sorin XTRA User manual

Operator’s Manual
SOFTWARE VERSION 2.00
20077/021 US
FOR US MARKET ONLY

20077/021 US XTRA Operator’s Manual
XTRA® is a registered trademark.
Microsoft® and Windows® are registered trademarks of the Microsoft
Corporation.
Manufacturer:
LivaNova Deutschland GmbH
Lindberghstrasse 25
D-80939 München Germany
Tel: [phone]
Fax: [phone]
Distributor in U.S.A.
LivaNova USA, Inc.
14401 West 65th Way
Arvada, Colorado USA 80004
Tel: [phone]
Tel: [phone]
Fax: [phone]

XTRA Operator’s Manual 20077/021 US
Table of Contents
Chapter 1: Introduction and Safety
About the Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Introducing the XTRA System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Contraindication for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Storage and Transporting Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Electrical Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Installation of the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Unpacking and Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Storage and Transport Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Addresses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Return of Used Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
For North American Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
For International Customers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Disposal in Accordance with Environmental Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Chapter 2: Overview
Advantages of Intra- and Postoperative Red Cell Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Description of the XTRA System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
How the XTRA System Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Collection and Anticoagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Reinfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
The Basic XTRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Options Available with XTRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Programmability Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Emergency Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Vacuum System (XVAC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Preoperative Sequestration Option (PPP and PRP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Data Management Options (USB, Printer, RS232) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Quality Control Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Chapter 3: System Description
Machine Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Hooks and Tray Holders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
IV Pole and Reservoir Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Reservoir Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Touch Screen Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Centrifuge Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Clamps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Processing Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Air Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Quality Control Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
XVAC Vacuum Module (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

20077/021 US XTRA Operator’s Manual
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Order Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Disposable Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Collection Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Bowl Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Procedure Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Selecting the Disposable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Selecting the Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Order Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Anticoagulant Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Wash Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
Accessories and Optional Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
Chapter 4: Installing the Disposables
Setup for Standby Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Supplies Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Setup for Whole Blood Separation Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Setup for Intraoperative Red Cell Recovery and Reinfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Supplies Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Step-by-step Procedures for Installing Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Step 1: Installing the Blood Collection Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Step 2: Connecting the Suction Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Step 3: Setup of the Vacuum Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Step 4: Installing the Bowl Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Step 5: Connecting Wash Lines to the Saline solution Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Step 6: Hanging the Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Other Setups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Blood Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Procedure for Removing Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Chapter 5: Processing
Operating the Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Screen Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
The Displets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Modification of Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Running a Case With the XTRA System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Loading the Pump Segment for a New Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Processing a Cycle in Automatic or 1 Touch Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Pausing and Resuming the Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Ending the Current Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Unloading the Pump Loop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Emptying the RBC Line Without Ending the Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Closing the End of Case Screen Without Ending the Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Retaining Case Data Between Power Cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Dealing With Expected Warnings During a Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Reservoir Empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Wash Bag Empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
RBC Bag Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Waste Bag Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Factory Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
The Autotransfusion Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23
Popt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Pstd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Pfat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Post-op . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Protocol Parameters (ATS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
The Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Automatic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

XTRA Operator’s Manual 20077/021 US
1 Touch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Selecting the Active Protocol and Operating Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Set the Active Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Set the Active Operating Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Touch Screen User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Alarms Disabled Confirmation Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Ready Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38
Processing Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39
Fat Removal Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41
Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-44
End of Case Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50
Help Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Past Cases Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Automatic Reseparation Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-55
Stop Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-55
Power Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-55
Chapter 6: Special Cycles
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Enabling Purge and Prime IV Special Cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
The Special Cycles Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Returning Fluid to the Reservoir: the Return Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Adding Fluid to a Partially Filled Bowl: The Concentrate Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Priming the Reinfusion Line: Prime IV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Removing Air From the RBC Bag: The Purge Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Reinfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Connecting the Blood Administration Set to the XTRA RBC Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Chapter 7: Automated Functions
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Enabling Optional Automated Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Autostart Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Continue Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Last Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Double Volume Wash Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Better Quality Wash (BQW) Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Better Empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Chapter 8: Configuring XTRA
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
The Settings Tab of the Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Configuration Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
How to Enter the Configuration Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Exit From the Configuration Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Predefined Feature Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Configuration Mode Screen Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Chapter 9: Programmability Option
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Enabling Programmability Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Creating Custom Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Entering Values and Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Creating a New Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Adjusting Parameters of a Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Renaming a Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Changing the Wakeup Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Deleting a Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

20077/021 US XTRA Operator’s Manual
The Protocol/Mode Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Mode Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Protocol Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Mode Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Save Modifications and Close Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Chapter 10: Preoperative Sequestration (PPP and PRP)
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Enabling the Preoperative Sequestration Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Overview of Preoperative Sequestration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Sequestration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Order Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Setup for Preoperative Sequestration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Supplies Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Installing the Blood Collection Reservoir, Connecting the Aspiration Line,
Setup of the Vacuum Line, Installing the Bowl Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Connecting the 4-Way Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Connecting and Hanging the Blood Transfer Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
Connecting the Blood Bag Connection Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Selecting the Active Protocol and Operating Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Running a Preoperative Sequestration Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Processing Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Loading the Pump Segment for a New Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
Processing a Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
The Concentrate Cycle (With the PPP/PRP Protocols) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Dealing With Expected Warnings During a Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Whole Blood Bag Empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
PPP Bag Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
PRP Bag Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
RBC Bag Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Finishing Preoperative Separation and Preparing for Blood Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-19
Tally Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
The Preoperative Sequestration Factory Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
Overview of the Preoperative Sequestration Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
PPP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
PRP1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-23
PRP2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-23
Protocol Parameters (PPP and PRP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Preoperative Sequestration Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
Spill Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
Chapter 11: Data Download Option
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Enabling Data Download Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
XTRA Output Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
USB Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
RS232 Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Case Data Download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Entering and Modifying Optional Case Data Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Selecting Past Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Selecting the Output Device for Data Download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Sending Tallies to the Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Sending Tallies to the XTRA USB Memory Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Sending Tallies to the Stöckert Data Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
Sending Tallies to a PC Through the RS232 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
XTRA Data Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
General Report Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Additional Cycle Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11

XTRA Operator’s Manual 20077/021 US
Chapter 12: Quality Management Option
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Enabling Quality Management Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Hematocrit (Hct) Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Supernatant Removal Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Waste Line Color Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Warnings Related to Waste Line Color Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Chapter 13: Vacuum Module
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
Intraoperative Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
Postoperative Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
Setting Wakeup Values for Vacuum Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
Preliminary Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
Performing a Blood Collection Procedure With the XVAC Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
XVAC Used Through the XTRA System Touch Screen Interface (Remote Control) . . . . . . . . . . . . . . . . . . . 13-3
Use of the XVAC System Through the XVAC Control Panel (Local Control) . . . . . . . . . . . . . . . . . . . . . . . . 13-6
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
List of Fatal Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
Alarm Management in Local Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
Alarm Management in Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
Chapter 14: Troubleshooting
General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Supervision and Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Alarms and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Visual Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2
Audible Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2
Stop Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3
Alarms and Warnings During Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3
During Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-8
Equipment Malfunctions (Fatal Errors) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-23
Therapy Concerns Unrelated to the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-25
Quality of Salvaged Blood and Blood Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-27
Chapter 15: Maintenance
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-1
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-1
General Maintenance Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-1
Routine Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-2
Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-2
List of Operator-Replaceable Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-6
Pump Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-6
Centrifuge Well Fluid Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-8
Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-9
Regular maintenance checks by authorized service technicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-9
Machine Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-9
Chapter 16: Technical Data
Technical Features of the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-1
Operating Features of the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-2

20077/021 US XTRA Operator’s Manual
Chapter 17: Warranty
Limited warranty and contractual conditions for LivaNova medical equipment . . . . . . . . . . . . . . . . . . . . . . . . . 17-1
Warranty expiry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-1
Contents and necessary requirements of the Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-1
Appendix A: Safety Standards EN 60601-1-2
Information on electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Guidance and manufacturer’s declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Appendix B: Approvals and Test Certificate
EMC Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
EMC Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
EMC Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Electrical and Mechanical Safety Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Appendix C: Quick Operating Instructions
Appendix D: Recommended Fluid Bag Configurations
Appendix E: Symbols and Abbreviations
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
Electrical Symbols on the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
Symbols on the Unit and on the Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Units Conversion Table and Measuring Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

XTRA Operator’s Manual 20077/021 US
List of Figures
Chapter 1: Introduction and Safety
Chapter 2: Overview
Figure 2-1 Position of Separated Whole Blood Components in Centrifuge Bowl ........................................................2-3
Chapter 3: System Description
Figure 3-1 XTRA Front View .................................................................................................................................3-1
Figure 3-2 XTRA Rear View ...................................................................................................................................3-2
Figure 3-3 Front Handle (left), Rear Handle (center), and Rear Transport Handle (right) .........................................3-3
Figure 3-4 Hooks on Left Side of XTRA .................................................................................................................3-3
Figure 3-5 Left: Disposable Tray on Tray Holders; Right: Waste Bag on Right-Side Hooks .......................................3-4
Figure 3-6 Cart ..................................................................................................................................................3-4
Figure 3-7 Spring Lever Releases Cart ..................................................................................................................3-5
Figure 3-8 Lifting Body from Cart .........................................................................................................................3-5
Figure 3-9 XTRA Body and Cart .............................................................................................................................3-6
Figure 3-10 Reservoir and IV Pole .........................................................................................................................3-6
Figure 3-11 Reservoir Holder .................................................................................................................................3-7
Figure 3-12 XTRA Touch Screen Display Panel ........................................................................................................3-8
Figure 3-13 Centrifuge Assembly ...........................................................................................................................3-9
Figure 3-14 Centrifuge Well Fluid Container ......................................................................................................... 3-10
Figure 3-15 Left: Clamps With Clamp Lid Open | Right: Clamp Lid Closed and Latched .......................................... 3-11
Figure 3-16 Visible Parts of the XTRA Processing Pump ........................................................................................... 3-12
Figure 3-17 Location of the Air Detector ............................................................................................................... 3-12
Figure 3-18 Location of the Hematocrit and Waste Line Color Indicators ................................................................. 3-13
Figure 3-19 Left: Vacuum Module | Right: Integrated Vacuum Module ................................................................ 3-13
Figure 3-20 XVAC Release Screw ........................................................................................................................... 3-14
Figure 3-21 XVAC Control Panel ............................................................................................................................ 3-14
Figure 3-22 XTRA With Disposable Set Installed (Front View) ................................................................................. 3-15
Figure 3-23 XTRA With Disposable Set Installed (Top View) .................................................................................... 3-16
Figure 3-24 XTRA Collection Kit (CARDIO TOP) ...................................................................................................... 3-17
Figure 3-25 XTRA Collection Reservoir (TOP version) ............................................................................................. 3-18
Figure 3-26 Collection Reservoir Lid Ports ............................................................................................................ 3-18
Figure 3-27 Left: Reservoir with TOP Outlet | Right: Reservoir with BOTTOM Outlet .............................................. 3-19
Figure 3-28 Aspiration Line .................................................................................................................................. 3-20

20077/021 US XTRA Operator’s Manual
Figure 3-29 Vacuum Line .................................................................................................................................... 3-20
Figure 3-30 Cardio Kit ......................................................................................................................................... 3-21
Figure 3-31 Bowl Set .......................................................................................................................................... 3-21
Figure 3-32 Cross-Section of Latham Centrifuge Bowl ............................................................................................ 3-22
Figure 3-33 Waste Bag ........................................................................................................................................ 3-23
Figure 3-34 Red Blood Cells (RBC) Bag ................................................................................................................. 3-24
Figure 3-35 Procedure Set ................................................................................................................................... 3-26
Chapter 4: Installing the Disposables
Figure 4-1 Raising the Reservoir Holder ................................................................................................................4-3
Figure 4-2 Positioning the Blood Collection Reservoir on the Reservoir Holder .........................................................4-4
Figure 4-3 Positioning the Blood Collection Reservoir on the Reservoir Holder ........................................................4-5
Figure 4-4 Positioning the Blood Collection Reservoir on the Reservoir Holder ........................................................4-6
Figure 4-5 Machine Top .......................................................................................................................................4-7
Figure 4-6 Inserting the Centrifuge Bowl ..............................................................................................................4-8
Figure 4-7 Inserting the Bowl in Order to Avoid Wobbling ......................................................................................4-8
Figure 4-8 Seating the Pump Loop Cartridge (Left); Latching the Clamp Lid (Right) .................................................4-9
Figure 4-9 Connecting the Bowl Set to the Top of the Blood Collection Reservoir .....................................................4-9
Figure 4-10 Connecting the Bowl Set to the Bottom of the Blood Collection Reservoir ................................................4-9
Figure 4-11 Connecting the Wash Lines (Yellow) to the Washing Solution ............................................................... 4-10
Figure 4-12 Connecting the Waste Bag ................................................................................................................ 4-11
Chapter 5: Processing
Figure 5-1 Example of an Enabled Button .............................................................................................................5-1
Figure 5-2 Example of in Inactive (Left) and Active (Right) Toggle Button ...............................................................5-1
Figure 5-3 Example of a Disabled Button ..............................................................................................................5-1
Figure 5-4 Typical Autotransfusion Processing Screen Structure .............................................................................5-2
Figure 5-5 Reservoir Displet (Open and Closed) ....................................................................................................5-3
Figure 5-6 Vacuum Displet ...................................................................................................................................5-3
Figure 5-7 RBC’s Displet ......................................................................................................................................5-4
Figure 5-8 Waste Bag Displet ...............................................................................................................................5-4
Figure 5-9 PPP/PRP Displet ..................................................................................................................................5-4
Figure 5-10 Processing Displet ...............................................................................................................................5-4
Figure 5-11 A Text Box Before and After Being Selected for Editing .........................................................................5-5
Figure 5-12 Rear Panel of the XTRA ........................................................................................................................5-6
Figure 5-13 Setup Screen ......................................................................................................................................5-7
Figure 5-14 Ready Screen .....................................................................................................................................5-8

XTRA Operator’s Manual 20077/021 US
Figure 5-15 Fill Phase of the Processing Screen .......................................................................................................5-9
Figure 5-16 Wash Phase of the Processing Screen ................................................................................................. 5-10
Figure 5-17 Empty Phase of the Processing Screen ............................................................................................... 5-11
Figure 5-18 Fill Phase Paused .............................................................................................................................. 5-12
Figure 5-19 Wash Phase Paused .......................................................................................................................... 5-12
Figure 5-20 Wash Phase Paused with Pfat protocol ............................................................................................... 5-13
Figure 5-21 Empty Phase Paused ......................................................................................................................... 5-13
Figure 5-22 End of Case Screen ........................................................................................................................... 5-15
Figure 5-23 Reservoir Empty Warning .................................................................................................................. 5-18
Figure 5-24 Wash Bag Empty Warning ................................................................................................................. 5-19
Figure 5-25 RBC Bag Full Warning ....................................................................................................................... 5-20
Figure 5-26 Waste Bag Full Warning .................................................................................................................... 5-21
Figure 5-27 Disposable Setup for ATS Protocols .................................................................................................... 5-23
Figure 5-28 Emergency Activation Screen ............................................................................................................. 5-27
Figure 5-29 Ready Screen in Manual Mode ........................................................................................................... 5-32
Figure 5-30 Fill Phase in Manual Mode ................................................................................................................. 5-32
Figure 5-31 Wash Phase in Manual Mode ............................................................................................................. 5-33
Figure 5-32 Empty Phase in Manual Mode ............................................................................................................ 5-33
Figure 5-33 Protocol/Mode Tab ............................................................................................................................ 5-34
Figure 5-34 Example Alarms Disabled Confirmation Screen .................................................................................... 5-36
Figure 5-35 Setup Screen .................................................................................................................................... 5-37
Figure 5-36 Ready Screen ................................................................................................................................... 5-38
Figure 5-37 Fill Phase of the Processing Screen ..................................................................................................... 5-39
Figure 5-38 Wash Phase of the Processing Screen ................................................................................................. 5-40
Figure 5-39 Empty Phase of the Processing Screen ............................................................................................... 5-41
Figure 5-40 Fat Removal – Wash processing screen .............................................................................................. 5-42
Figure 5-41 Fat Removal - Empty processing screen .............................................................................................. 5-42
Figure 5-42 Fat Removal – Conc processing screen ............................................................................................... 5-43
Figure 5-43 Tally Tab of the Menu Screen ............................................................................................................ 5-44
Figure 5-44 ID Tab of the Menu Screen ................................................................................................................ 5-46
Figure 5-45 Protocol/Mode Tab of the Menu Screen .............................................................................................. 5-47
Figure 5-46 Settings Tab of the Menu Screen ....................................................................................................... 5-48
Figure 5-47 Reset Confirmation Screen ................................................................................................................. 5-49
Figure 5-48 End of Case Screen ........................................................................................................................... 5-50
Figure 5-49 Help Screen ...................................................................................................................................... 5-51
Figure 5-50 Past Cases Screen ............................................................................................................................. 5-52

20077/021 US XTRA Operator’s Manual
Figure 5-51 Automatic Reseparation Screen .......................................................................................................... 5-55
Chapter 6: Special Cycles
Figure 6-1 Special Cycles Screen ..........................................................................................................................6-1
Figure 6-2 Return Screen ....................................................................................................................................6-2
Figure 6-3 Concentrate Screen .............................................................................................................................6-3
Figure 6-4 Prime IV Screen (Paused) ....................................................................................................................6-5
Figure 6-5 Purge Screen ......................................................................................................................................6-6
Figure 6-6 Top: “Y”-Type Blood Administration Set with Integral Filter
Bottom: Filter with “Y”-Type Blood Administration Set ...........................................................................6-9
Chapter 7: Automated Functions
Figure 7-1 Autostart Activation Screen ..................................................................................................................7-2
Figure 7-2 Last Bowl Activation Screen .................................................................................................................7-4
Chapter 8: Configuring XTRA
Figure 8-1 Settings Tab of the Menu Screen .........................................................................................................8-2
Figure 8-2 Configuration Mode Password Screen ...................................................................................................8-3
Figure 8-3 Features Tab of the Configuration Mode ...............................................................................................8-4
Figure 8-4 Protocol Set Tab of the Configuration Mode ..........................................................................................8-6
Figure 8-5 Wakeup Tab of the Configuration Mode ................................................................................................8-7
Figure 8-6 Display Tab of the Configuration Mode .................................................................................................8-8
Figure 8-7 Warnings Tab of the Configuration Mode ..............................................................................................8-8
Figure 8-8 ID Tab of the Configuration Mode Screen ........................................................................................... 8-10
Figure 8-9 Edit Field List Screen ......................................................................................................................... 8-11
Figure 8-10 Language Tab of the Configuration Mode ........................................................................................... 8-12
Chapter 9: Programmability Option
Figure 9-1 Keyboard Screen (Caps & Numbers ON) ...............................................................................................9-2
Figure 9-2 Fill Phase Screen With Modifiable Parameter .........................................................................................9-4
Figure 9-3 Protocol/Mode Tab of the Menu Screen ................................................................................................9-7
Chapter 10: Preoperative Sequestration (PPP and PRP)
Figure 10-1 Sequestration Set ............................................................................................................................. 10-3
Figure 10-2 Sequestration Set 4-Way Connection .................................................................................................. 10-6
Figure 10-3 Blood Transfer Bag Setup: For PPP, PRP1, and PRP2 Procedures .......................................................... 10-7
Figure 10-4 Hang the Blood Transfer Bags, Keeping the Inlet Line Facing Up .......................................................... 10-7
Figure 10-5 Connecting the Blood Bag Connection Line ......................................................................................... 10-8
Figure 10-6 Setup Screen .................................................................................................................................. 10-10

XTRA Operator’s Manual 20077/021 US
Figure 10-7 Ready Screen (PRP2) ...................................................................................................................... 10-11
Figure 10-8 Sequestration Fill Phase of the Processing Screen .............................................................................. 10-12
Figure 10-9 Spill Phase (PPP) of the Processing Screen ........................................................................................ 10-13
Figure 10-10 Empty Phase of the Processing Screen ............................................................................................. 10-15
Figure 10-11 Concentrate Screen (Preoperative Protocols) ..................................................................................... 10-16
Figure 10-12 Tally Tab of the Menu Screen (PRP2) ............................................................................................... 10-20
Figure 10-13 Disposable Setup for Sequestration Protocols .................................................................................... 10-21
Figure 10-14 Spill PPP Phase of the Processing Screen (Paused) ............................................................................ 10-25
Figure 10-15 Spill PRP Phase of the Processing Screen .......................................................................................... 10-26
Chapter 11: Data Download Option
Figure 11-1 Data Ports Panel on Rear of Machine .................................................................................................. 11-1
Figure 11-2 Integrated Dot-Matrix Printer ............................................................................................................. 11-2
Figure 11-3 Tally Tab of the Menu Screen ............................................................................................................ 11-3
Figure 11-4 ID Tab of the Menu Screen ................................................................................................................ 11-4
Figure 11-5 Past Cases Screen ............................................................................................................................. 11-5
Figure 11-6 Destination Drop-Down Menu (Expanded) .......................................................................................... 11-6
Chapter 12: Quality Management Option
Figure 12-1 Location of the Hct and WLC Indicators .............................................................................................. 12-1
Chapter 13: Vacuum Module
Figure 13-1 XVAC Vacuum Module ....................................................................................................................... 13-1
Figure 13-2 Vacuum Line Connecting Reservoir to Inlet Port .................................................................................. 13-3
Figure 13-3 Cable connections from the XVAC module to the XTRA system ............................................................... 13-4
Figure 13-4 XVAC Rear Panel ................................................................................................................................ 13-4
Figure 13-5 Vacuum Displet ................................................................................................................................. 13-4
Figure 13-6 XVAC Control Panel ............................................................................................................................ 13-6
Chapter 14: Troubleshooting
Figure 14-1 Example Warning Screen ................................................................................................................... 14-2
Chapter 15: Maintenance
Figure 15-1 Power Supply Cable (A); Serial Cable and Vacuum Pump Power Supply (B) ........................................... 15-2
Figure 15-2 Clamps and Pump Loop Ejector .......................................................................................................... 15-4
Figure 15-3 Centrifuge Well ................................................................................................................................. 15-4
Figure 15-4 Removal of the Overflow Trap from the Vacuum Pump ........................................................................ 15-5
Figure 15-5 Composition of the Overflow Trap ...................................................................................................... 15-5

20077/021 US XTRA Operator’s Manual
Figure 15-6 Sensors Located on Machine Top ....................................................................................................... 15-6
Figure 15-7 Sensors Located on Machine Top ....................................................................................................... 15-7
Figure 15-8 Replacement of the Paper Roll ........................................................................................................... 15-8
Figure 15-9 Removal of the Centrifuge Well Fluid Container ................................................................................... 15-8
Chapter 16: Technical Data
Chapter 17: Warranty
Appendix A: Safety Standards EN 60601-1-2
Appendix B: Approvals and Test Certificate
Appendix C: Quick Operating Instructions
Appendix D: Recommended Fluid Bag Configurations
Appendix E: Symbols and Abbreviations

Introduction and Safety
XTRA Operator’s Manual 20077/021 US 1-1
Chapter 1: Introduction and Safety
About the Operating Instructions
These instructions are intended for personnel responsible for the use and/or maintenance of the XTRA
Autotransfusion System, which is an autologous blood recovery system for intra- and postoperative
autotransfusion, as well as for preoperative sequestration. These instructions contain all the
information necessary for the understanding and use of the unit. Before operating the XTRA, read the
instructions carefully.
See “Installation of the Unit” on page 1-14 for unpacking and installation instructions.
Following this chapter, for the rest of the manual, information intended to alert the user to potentially
dangerous situations and to ensure correct and safe use of the device is indicated in the text in the
following three ways:
Note: A “Note” draws the operator’s attention to important operating procedures and conditions.
Introducing the XTRA System
The XTRA is an autologous blood recovery system which collects blood and then concentrates and
washes the red blood cells.
The XTRA can also be used to recover plasma during surgery. The Preoperative Sequestration or
Platelet Rich Plasma (PRP) function allows separation of blood drawn from the patient so that plasma
containing platelets and clotting factors can be returned to the patient.
The XTRA utilizes the Latham centrifuge bowl, designed specifically for blood processing during any
kind of surgical blood loss. The Latham bowl has a conic-side configuration and produces a high
quality red blood cell product at reduced processing times.
The XTRA may be used for processing:
• Blood shed by a patient during surgery
• Blood collected preoperatively from trauma patients (e.g., traumatic hemothorax)
• Blood collected postoperatively from chest or wound drains
• Blood in the heart-lung bypass circuit either during or after bypass
• Blood collected for the purpose of autologous preoperative sequestration
This manual is intended for users of the XTRA. The procedures recommended in this book have been
developed and tested to provide safe, reliable, and efficient operation of the XTRA. It is important that
all operators thoroughly understand the information in this manual before attempting to use the XTRA.
WARNING
A “Warning” indicates serious consequences and possible dangers
for the safety of the user and/or the patient. These situations may
result from the use of a device in normal operating conditions or
from its misuse. These warnings help define both the operating
limits and the measures to be taken in such situations.
CAUTION
A “Caution” indicates any possible precaution that the user must adopt in
order to guarantee the safe and correct operation of the unit.

Introduction and Safety
1-2 20077/021 US XTRA Operator’s Manual
This chapter of the manual addresses indications and contraindications for use; warnings, precautions,
and adverse effects; and information about service and returning used products. Following is an
overview of the remaining chapters of this manual.
Chapter 2: Overview Discusses the advantages of intra- and postoperative red cell
recovery, some of the clinical applications, and a brief
description of how the XTRA system works.
Chapter 3: System Description Provides a detailed description of the XTRA machine
components and disposable products.
Chapter 4: Installing the Disposables Presents step-by-step instructions for installing the XTRA
processing sets and other disposables.
Chapter 5: Processing Details the procedures for carrying out intraoperative
processing, including a full description of the ATS factory
protocols and the touch screen user interface.
Chapter 6: Special Cycles Explains the Purge, Prime IV, Return, and Concentrate cycles.
Chapter 7: Automated Functions Explains the Autostart, Continue, Last Bowl, Double Volume
Wash, Better Quality Wash, and Better Empty functions.
Chapter 8: Configuring XTRA Provides instructions for entering the password-protected
Configuration Mode Screen to make persistent configuration
changes to the XTRA.
Chapter 9: Programmability Option Provides information about modifying protocols and about
creating custom protocols using the Programmability
Option.
Chapter 10: Preoperative Sequestration (PPP and PRP) Details the procedures for carrying out preoperative
sequestration, including a full description of the PPP and
PRP factory protocols.
Chapter 11: Data Download Option Explains how to print and save case data and how to replace
the printer ribbon and paper.
Chapter 12: Quality Management Option Describes the waste transparency and hematocrit indicators
and their corresponding user interface elements.
Chapter 13: Vacuum Module Describes the XVAC vacuum system
Chapter 14: Troubleshooting Explains how to recognize and solve problems, including all
alarm conditions.
Chapter 15: Maintenance Covers routine cleaning and preventive maintenance.
Chapter 16: Technical Data Lists the equipment specifications, performance parameters,
and XTRA protocol settings.
Chapter 17: Warranty Limited warranty and contractual conditions for LivaNova
medical equipment.
Appendix A: Safety Standards EN 60601-1-2 Information on electromagnetic safety standards.
Appendix B: Approvals and Test Certificate Standards the XTRA complies with.
Appendix C: Quick Operating Instructions Several Quick Operating Instruction guides which cover several
aspects of setting up and processing with the XTRA system.
Appendix D: Recommended Fluid Bag Configurations Lists the recommended maximum amounts and the
distribution of fluids to be hung on the I.V. pole and handle
support pins of the XTRA.
Appendix E: Symbols and Abbreviations Lists the symbols and abbreviations used in this manual.

Introduction and Safety
XTRA Operator’s Manual 20077/021 US 1-3
Indications for Use
The XTRA is indicated for use for intraoperative recovery of blood, washing of blood collected in the
postoperative period and preoperative sequestration (with indirect patient connection).
Typical clinical applications of autotransfusion include the following surgical specialties:
• Cardiovascular
• Orthopedics
•Thoracic
•Transplant surgery
• Emergency (trauma)
• Neurosurgery
• Obstetrics and gynecology
•Urology
Contraindication for Use
There are no known contraindications for the XTRA. However, the use of blood processed by this device
may be contraindicated under some circumstances (see Warning #22 and #23). The responsibility for
the use of the device in all cases belongs solely to the physician in charge.
General Warnings
1. The use of operating or maintenance procedures other than those published by LivaNova
(hereafter referred to as “the company”), or the use of accessory devices not recommended by
the company may result in patient injury or loss of life. The company will not be responsible for
patient safety or equipment performance if the procedures to operate, maintain, and calibrate the
XTRA system are other than those specified by company. Persons performing the procedures must
be appropriately trained and qualified.
Any equipment modifications must be performed by qualified persons and be approved in writing
by the company.
All electrical installations must comply with all applicable local electrical codes and company
specifications.
2. Read the instructions carefully prior to use. Prior to use, this manual must be thoroughly read and
understood by the personnel assigned to operate the system. Improper use may cause personal
injury and damage to the equipment. Improper use, repair or modifications by unauthorized
personnel may invalidate any warranty agreement. In XTRA displayed information and in these
instructions for use, the meaning of “fatal alarm” expression is considered as equivalent to “fatal
error”. The expression “fatal alarm” has been adopted because it is considered more familiar to
the user, but, from regulatory point-of-view, it must be considered as “fatal error”. In a similar
way, in XTRA displayed information and in these instructions for use, the meaning of “alarm”
expression is considered as equivalent to “information signal”.
3. The XTRA must be operated only by qualified personnel, trained in the use of the unit.
Qualified
and trained personnel
’ means personnel capable of operating according to the directions and
methods of use indicated in this manual.
4. Check the product thoroughly on delivery. Transportation and subsequent handling may cause
structural and functional damage to the unit.
5. XTRA should be overhauled by authorized service technicians every 12 months.
6. Disconnect the XTRA autotransfusion system from the power source prior to cleaning and
maintenance.
7. Do not use the XTRA in the presence of flammable agents because an explosion and/or fire may
result.

Introduction and Safety
1-4 20077/021 US XTRA Operator’s Manual
8. The availability of alarms does not relieve the operator of his or her obligation to carefully monitor
the entire system during operation. Unattended processing can lead to the development of
problems with the operation of the system and/or with the quality of the end product.
9. Do not touch any moving parts of the centrifuge or pump. Injury may result.
10. Besides making the unit not operational, hardware alarms also stop the vacuum pump.
11. The American Association of Blood Banks recommends the following guidelines for expiration of
salvaged blood:1
1American Association of Blood Banks.
Standards for Perioperative Autologous Blood Collection
and Administration
. 4th Edition. Bethesda, MD. 2010 Reference Standard 5.1.8A (Handling,
Storage, and Expiration of Perioperative Autologous Red Cell Blood Products).
Collection Type Storage temperature
Time from the Start
of Collection to
Expiration
Time from
Completion of
Processing to
Expiration
Special Conditions
Acute normovolemic
hemodilution (whole
blood)
Room temperature 8 hours N/A None
Acute normovolemic
hemodilution (whole
blood)
1-6 °C 24 hours N/A Storage at 1-6 °C shall
begin within 8 hours
of start of collection
Intraoperative blood
recovery with
processing
Room temperature N/A 4 hours None
Intraoperative blood
recovery with
processing
1-6 °C (N/A if bacterial
contamination is
suspected)
24 hours N/A Storage at 1-6 °C shall
begin within 4 hours
of completion of
processing
Intraoperative blood
recovery without
processing
Room temperature 6 hours N/A None
Shed blood under
postoperative or
posttraumatic
conditions with or
without processing
N/A 6 hours N/A None
Combined Intraoperative
and postoperative
blood recovery with
processing
Room temperature Postoperatively
processed units: 6
hours from the start
of postoperative
collection
Intraoperatively
processed units: 4
hours
None
Red Blood cells prepared
by apheresis and
intended for
transfusion
Room temperature 8 hours N/A None
Red Blood cells prepared
by apheresis and
intended for
transfusion
1-6 °C 24 hours N/A Storage at 1-6 °C shall
begin within 8 hours
of collection
Table 1-1 Guidelines for Expiration of Salvaged Blood

Introduction and Safety
XTRA Operator’s Manual 20077/021 US 1-5
12. The American Association of Blood Banks recommends the following guidelines for expiration of
Perioperative Autologous Non-Red-Cell Blood Products:2
13. To minimize blood cell trauma, LivaNova recommends that vacuum levels no higher than (in
absolute value) 150 mmHg (20 kPa) be used when aspirating fluid from the surgical field.3
14. Carefully observe the system for leaks before and during use. Leakage may result in loss of
sterility or loss of blood and/or fluid. If leakage is observed before or during use, replace or
retighten the leaking component as appropriate.
15. To prevent interference with anticoagulation when using citrate anticoagulants, do not use wash
solutions containing calcium. Only sterile 0.9% normal saline (injectable or approved for cell
processing) should be used as a wash solution.
16. Be sure that every bowl to be processed is adequately filled and packed before washing.
Otherwise, the Wash cycle will be ineffective and the hematocrit will be low.
17. Washed, packed red cells are depleted of clotting factors. Patients should be monitored for the
presence of clotting abnormalities associated with the transfusion of large volumes of packed red
blood cells without clotting factors. Physicians should be prepared to institute the appropriate
therapy.
18. Do not reinfuse the patient’s blood from the primary RBC bag when it is connected to the XTRA
autologous transfusion circuit. Reinfusion from the primary reinfusion bag connected to the circuit
could lead to air embolism.
19. To minimize the complications of particulate matter infusion and the risk of air embolism, use of
an in-line microaggregate filter on the patient reinfusion line is STRONGLY RECOMMENDED.
20. Do not reinfuse under pressure (i.e., do not use a blood pressure cuff on the reinfusion bag).
Reinfusion under pressure could lead to air embolism.
21. To reduce risk of air embolism, remove all air from the primary reinfusion bag before handing the
bag over for reinfusion.
22. The physician ordering the use of this system and/or the surgeon operating the suction/collection
wand shall use discretion in the collection of the following substances:
2American Association of Blood Banks.
Standards for Perioperative Autologous Blood Collection
and Administration
. 3rd Edition. Bethesda, MD. 2007 Reference Standard 5.1.8 (Handling,
Storage, Transportation).
Collection Type Storage temperature Expiration Special Conditions
Platelet-rich plasma intended
for transfusion
Room temperature N/A Shall be used before the
patient leaves the operating
room or clinical procedure
area
Platelet-rich plasma intended
for topical use
Room temperature N/A Shall be used before the
patient leaves the operating
room or clinical procedure
area
Platelet-poor plasma intended
for topical use
Room temperature N/A Shall be used before the
patient leaves the operating
room or clinical procedure
area
Thrombin intended for topical
use
Room temperature Within 6 hours after
component preparation (or
not to exceed device
manufacture’s
recommendations)
Shall be used before the
patient leaves the operating
room or clinical procedure
area
Table 1-2 Guidelines for Expiration of Perioperative Autologous Non-Red-Cell Blood Products
3
Guidelines for blood recovery and reinfusion in surgery and trauma . Bethesda, MD; American
Association of Blood Banks, 1997: 19-22.

Introduction and Safety
1-6 20077/021 US XTRA Operator’s Manual
23. The following substances that are not considered in the American Association of Blood Banks
publication,4 should be added to the list:
Potentially harmful substance Effects Recommended action in order of
priority
Amniotic fluid Soluble component contains proteolytic
enzymes which could activate clotting.
Squamous cells could cause pulmonary
emboli
1. Do not aspirate into system
Fecal contamination Sepsis 1. Do not aspirate into system
2. Aspiration may be necessary in
emergency cases
Tumor cells Potential risk of metastasis 1. Do not aspirate into system
2. Aspiration may be necessary in
emergency cases
3. Irradiation of salvaged blood is always
recommended
Clotting Adjuncts
•Topical thrombin
•Fibrin Glue
Monofilament collagen
May activate clotting 1. Do not aspirate into system
2. Irrigate wound before resuming
salvage
Microfibrillar Collagen (e.g. Avitene) Causes platelet activation Do not aspirate into system
Betadine Reduces hemoglobin; seems to be a
reversible effect. May cause hemolysis;
may cause allergic reaction if patient is
sensitive to iodine
1. Do not aspirate into system
2. Irrigate wound before resuming
salvage
3. Thoroughly wash salvaged blood
Methylmethacrylate (fresh bone cement
only)
Toxicity; heat produced hemolysis 1. Do not aspirate into system
2. Irrigate wound before resuming
salvage
Gastric Fluids Contains proteolytic enzymes; could
activate clotting
1. Do not aspirate into system
2. Irrigate wound before resuming
salvage
3. Thoroughly wash salvaged blood
Antibiotics not licensed for intravenous use May be delivered in higher dose than
normal concentrations; potential serious
reactions (e.g. hypotension, shock).
1. Do not aspirate into system
2. Irrigate wound before resuming
salvage
Epinephrine May be delivered in higher than normal
concentrations. Studies show that the
catecholamines not removed. May
cause severe hypertension
1. Do not aspirate into system
2. Irrigate wound before resuming
salvage
Table 1-3 Suction/Collection Wand Substance Warnings
4Guidelines for blood recovery and reinfusion in surgery and trauma. Bethesda, MD; American
Association of Blood Banks, 1997: 19-22
Potentially harmful substance Effects Recommended action in order of
priority
Smoke produced on the operative site by
electrosurgical instrumentation
Carbonized particles may be aspirated
from the field and directed inside the
filter of the reservoir.
The smoke aspirated could produce a
brownish color on the vacuum line
connected to the reservoir
Keep away the aspirator from the
operative site during the use of
electrosurgical instrumentation.
Use evacuation systems to capture and
filter surgical smoke to remove odor,
particulates, and other potentially
hazardous by-products of electro
surgery procedures
Ceramic and metal debris released by
prosthetics materials
Effect of darkened tissue or clots (blue/
green/black) surrounding prosthesis
unknown to systemic circulation
Do not aspirate into system
Table 1-4 Addendum to Suction/Collection Wand Substance Warnings