Table of Contents
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Table of Contents
Related Manuals for sorin 75220
Summarization of Contents
Chapter 1: Introduction and Safety
General Warnings
Indicates serious consequences and possible dangers for user or patient safety.
General Precautions
Provides essential guidelines for safe and correct operation of the unit.
Installation of the Unit
Details requirements and procedures for installing the XTRA and XVAC systems.
Storage and Transport Conditions
Specifies environmental conditions for storing and transporting the unit.
Electrical Requirements
Specifies electrical connection requirements and safety compliance.
Service Information
Information on contacting LivaNova for technical support and maintenance.
Disposal in Accordance with Environmental Regulations
Guidelines for proper disposal of the system and its components.
Chapter 2: Overview
Description of the XTRA System
Overview of the XTRA system's components and capabilities.
How the XTRA System Works
Explains the intraoperative and postoperative processing steps.
Options Available with XTRA
Details programmable options like Programmability, Emergency, and XVAC.
Chapter 3: System Description
Machine Components
Identifies and illustrates the major components of the XTRA system.
Touch Screen
Describes the user interface and its interactive elements.
Centrifuge Assembly
Details the centrifuge arm, plate, and lid, including safety features.
Clamps
Explains the function and operation of the three clamps controlling fluid flow.
Disposable Description
Illustrates and labels the disposable components used with the XTRA.
Chapter 4: Installing the Disposables
Step-by-step Procedures for Installing Disposables
Provides detailed instructions for setting up all disposable components.
Step 1: Installing the Blood Collection Reservoir
Guide for correctly installing the blood collection reservoir.
Step 4: Installing the Bowl Set
Instructions for properly installing the centrifuge bowl set.
Procedure for Removing Disposables
Step-by-step process for safely removing all disposable components.
Chapter 5: Processing
Operating the Touch Screen
How to interact with the XTRA system via the touch screen interface.
Screen Structure
Overview of the layout and components of the processing screens.
Running a Case With the XTRA System
Step-by-step guide for performing a processing case.
The Fill Phase
Details the blood collection and centrifugation process.
The Wash Phase
Explains the saline wash process to remove contaminants.
The Empty Phase
Describes the process of transferring concentrated RBCs to the RBC bag.
Dealing With Expected Warnings During a Cycle
Information on common warnings and appropriate operator responses.
Factory Protocols
Explains the predefined processing methods available on the system.
Chapter 6: Special Cycles
Description
Overview of special cycles for unique processing circumstances.
Returning Fluid to the Reservoir: the Return Cycle
Allows returning blood from the bowl back to the reservoir.
Adding Fluid to a Partially Filled Bowl: The Concentrate Cycle
Used to complete filling the bowl from the RBC bag when reservoir is low.
Priming the Reinfusion Line: Prime IV
Simplifies priming the reinfusion line with saline wash solution.
Removing Air From the RBC Bag: The Purge Cycle
Allows the operator to remove air accumulated in the RBC bag.
Reinfusion
Describes methods for reinfusing processed red blood cells.
Chapter 7: Automated Functions
Description
Overview of automated functions for processing with the XTRA system.
Autostart Function
Automatically initiates the first Fill phase based on reservoir blood volume.
Continue Function
Sequentially processes cycles without operator intervention.
Last Bowl
Automates case conclusion by processing remaining blood.
Double Volume Wash Function
Doubles the wash volume for a single cycle.
Better Quality Wash (BQW) Function
Optimizes Wash phase via centrifuge decelerations and accelerations.
Better Empty
Solves incomplete bowl emptying by activating a special Empty phase.
Chapter 8: Configuring XTRA
Description
Overview of settings and optional features that can be configured.
The Settings Tab of the Menu Screen
Accesses basic system settings without a password.
Configuration Mode
Password-protected screen for general system configuration.
Setting the Enabled Protocols
Configures which processing protocols are available.
Setting the Wakeup Configuration
Determines initial system configuration at power on.
Warnings Tab
Configures alarm volumes, tones, durations, and bag warnings.
Chapter 9: Programmability Option
Description
Details the operator's ability to create custom protocols.
Enabling Programmability Option
Requires enabling 'User Protocols' in Configuration Mode.
Creating Custom Protocols
Steps to create, modify, and delete custom protocols.
Adjusting Parameters of a Protocol
How to modify parameters during runtime or via Protocol/Mode tab.
Renaming a Protocol
Steps to rename an existing custom protocol.
The Protocol/Mode Tab
Interface for selecting protocols, modes, and automations.
Chapter 10: Preoperative Sequestration (PPP and PRP)
Description
Overview of the XTRA's ability to separate plasma and platelets.
Overview of the Preoperative Sequestration Protocols
Details the PPP, PRP1, and PRP2 protocols for plasma/platelet collection.
Setup for Preoperative Sequestration
Steps for preparing the system for sequestration procedures.
Running a Preoperative Sequestration Case
Comprehensive guide for executing a sequestration case.
The Fill Phase
Details the blood collection and plasma/platelet separation process.
Spill Screen
UI for managing the Spill PPP and Spill PRP phases.
The Empty Phase
Describes transferring remaining components to the RBC bag.
Tally Information
How to view processed and collected volumes for sequestration cases.
Chapter 11: Data Download Option
Description
Overview of downloading processing tallies and information.
XTRA Output Devices
Description of integrated printer, USB, and RS232 ports for data transfer.
Case Data Download
Procedures for printing or downloading case data.
Sending Tallies to the Printer
Instructions for printing case data reports.
Sending Tallies to the XTRA USB Memory Device
Steps for saving case data to a USB storage device.
Sending Tallies to a PC Through the RS232 Port
Instructions for transmitting data to a PC via RS232.
Chapter 12: Quality Management Option
Description
Overview of indicators monitoring blood quality during processing.
Hematocrit (Hct) Indicator
Measures hematocrit of fluid entering and RBCs leaving the bowl.
Waste Line Color Indicator
Detects waste line color to assess wash quality.
Warnings Related to Waste Line Color Indicator
Explains quality warnings based on wash performance indicators.
Chapter 13: Vacuum Module
Description
Overview of the optional XVAC vacuum module and its components.
Operating Modes
Details the Intraoperative and Postoperative vacuum modes.
Performing an Intra or Post Blood Collection Procedure
Step-by-step guide for using the vacuum module for blood collection.
Alarms
Lists possible alarms, causes, and operator responses for the XVAC module.
Chapter 14: Troubleshooting
General Precautions
Emphasizes observing all alarms, warnings, and precautions for safe operation.
Alarms and Warnings
Explains the types of alerts (Warnings, Alarms, Fatal Errors) used by the system.
Alarms and Warnings During Setup
Lists and explains warnings that may occur during the setup phase.
During Processing
Details warnings and alarms that can occur during the processing cycle.
Equipment Malfunctions (Fatal Errors)
Lists fatal errors and required operator responses for hardware anomalies.
Quality of Salvaged Blood and Blood Product
Discusses quality issues and suggested measures to overcome them.
Chapter 15: Maintenance
Routine Maintenance
Importance and instructions for regular user maintenance.
Routine Visual Inspection
Guidelines for periodically inspecting the equipment for damage.
Cleaning and Disinfecting
Procedures for cleaning and disinfecting the XTRA system.
Sensors
Identifies and provides cleaning notes for various sensors.
List of Operator-Replaceable Parts
Lists parts that operators can replace, like the pump rotor.
Preventive Maintenance
Information on scheduled maintenance performed by authorized technicians.
Chapter 16: Technical Data
Technical Features of the Equipment
Lists specifications for unit and cart dimensions, display, keyboard, etc.
Operating Features of the Equipment
Details operational features like centrifuge speed and pump flow rates.
Chapter 17: Warranty
Limited warranty and contractual conditions for LivaNova medical equipment
Outlines the terms and conditions of the product warranty.
Cases in which the Warranty shall not be effective
Lists conditions under which the warranty is void.
Appendix A: Safety Standards EN 60601-1-2
Information on electromagnetic compatibility (EMC)
Details EMC requirements and guidance for the XTRA system.
Guidance and manufacturer's declaration – electromagnetic immunity
Specifies immunity test levels for electromagnetic disturbances.
Appendix B: Approvals and Test Certificate
EMC Standards
Lists the EMC standards the XTRA and XVAC equipment comply with.
Electrical and Mechanical Safety Standards
References safety standards for electrical and mechanical aspects.
Certification
Lists relevant certifications for quality assurance systems.
Appendix C: Quick Operating Instructions
Setting Up the Disposables
Provides a visual, step-by-step guide for setting up disposables.
Setting the Active Protocol and Mode
Quick guide on selecting protocols and operating modes.
Running an ATS Case
Brief instructions for performing an autotransfusion case.
Running a PRP Sequestration Case
Brief instructions for performing a PRP sequestration case.
Creating a Custom Protocol
Quick steps for creating user-defined processing protocols.
Appendix E: Symbols and Abbreviations
Electrical Symbols on the Unit
Identifies electrical symbols used on the device.
Symbols on the Unit and on the Packaging
Explains various symbols found on the unit and its packaging.
Abbreviations
Provides a list of abbreviations and units conversion tables.
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