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sorin XTRA - User Manual

sorin XTRA
304 pages
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Operator’s Manual
SOFTWARE VERSION 2.00
20077/021 US
FOR US MARKET ONLY

Table of Contents

Other manuals for sorin XTRA

Questions and Answers

Summary

Chapter 2: Overview

Description of the XTRA System

Details the XTRA system components, including its automated and programmable options.

How the XTRA System Works

Details the three stages of blood processing: Fill, Wash, and Empty.

Chapter 3: System Description

Machine Components

Illustrates and labels the major components of the XTRA system from front and back views.

Touch Screen Display Panel

Describes the control panel's components, including the touch screen display and physical Stop button.

Centrifuge Assembly

Locates and describes the centrifuge arm, plate, and lid, including safety features.

Clamps

Explains the function of three clamps used to control fluid flow during normal processing.

Processing Pump

Describes the processing pump's role in moving fluids and its operational rates.

Air Detector

Explains the ultrasonic air detector's function in sensing air and detecting empty conditions.

Quality Control Indicators

Describes indicators that monitor blood quality during processing.

XVAC Vacuum Module (Option)

Describes the optional vacuum module that connects to the XTRA cart for negative vacuum pressure.

Disposable Description

Shows a front view of the XTRA with the disposable set installed, labeling key components.

Collection Set

Describes the XTRA Collection Set, its components, and available configurations.

Blood Collection Reservoir

Details the XTRA Blood Collection Reservoir, its capacity, graduated scale, and port descriptions.

Aspiration Line

Describes the dual lumen tubing for mixing anticoagulant with aspirated blood.

Vacuum Line

Describes the clear plastic tubing used to create vacuum in the blood collection reservoir.

Bowl Set

Contains tubing harness, centrifuge bowl, waste bag, and RBC bag for processing blood.

Rapid Latham Centrifuge Bowl

Designed for concentration and separation of blood components with available sizes indicated by collar ring color.

Waste Bag

Describes the 10-liter waste bag with a slide clamp and drain valve for collecting overflow fluid.

Primary Red Blood Cells Bag (RBC)

Describes the one-liter primary RBC bag provided with the Bowl Set, including its ports.

Procedure Set

Equivalent to Collection Set CARDIO and Bowl Set, containing all components for blood collection and processing.

Anticoagulant Solution

Provides instructions for preparing and adjusting the anticoagulant solution flow rate.

Wash Solution

Recommends sterile normal saline as the wash solution and its availability in various sizes.

Chapter 4: Installing the Disposables

Setup for Intraoperative Red Cell Recovery and Reinfusion

Details the setup procedures for intraoperative red cell recovery and reinfusion.

Step 1: Installing the Blood Collection Reservoir

Provides step-by-step instructions for installing the blood collection reservoir.

Step 2: Connecting the Suction Line

Guides the user through preparing anticoagulant solution and connecting the dual lumen suction line.

Step 3: Setup of the Vacuum Line

Instructs on attaching the vacuum line to the XVAC system and reservoir, and regulating vacuum levels.

Step 4: Installing the Bowl Set

Provides step-by-step instructions for installing the bowl set, including opening the centrifuge arm and lid.

Step 5: Connecting Wash Lines to the Saline solution Containers

Guides on connecting wash lines to saline solution containers and spiking the solution bag.

Step 6: Hanging the Waste Bag

Provides instructions for removing and hanging the waste bag on the machine's panel.

Procedure for Removing Disposables

Details the steps for safely removing disposable sets after case completion.

Chapter 5: Processing

Operating the Touch Screen

Explains how to interact with the touch screen, including button states and important notes.

Screen Structure

Details the components of a typical autotransfusion processing screen.

Modification of Parameters

Explains how to modify parameters displayed in text boxes on various screens.

Running a Case With the XTRA System

Covers running intraoperative and postoperative protocols, including touch screen interface.

Unloading the Pump Loop

Details the procedure for unloading the pump loop to start a new case or shut down the machine.

Retaining Case Data Between Power Cycles

Explains how to resume an interrupted case by retaining case data after power loss.

Emergency

Provides a special protocol variation to minimize operator intervention in emergencies.

Selecting the Active Protocol and Operating Mode

Explains how to select protocols and operating modes from the Protocol/Mode tab.

Power Loss

Provides steps to manually empty the bowl and remove the disposable set after a power loss.

Chapter 6: Special Cycles

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 bowl filling from the RBC bag when reservoir volume is insufficient.

Priming the Reinfusion Line: Prime IV

Pumps wash solution into the RBC bag and empty line to simplify reinfusion line priming.

Removing Air From the RBC Bag: The Purge Cycle

Allows the operator to remove accumulated air from the RBC bag.

Reinfusion

Describes methods and precautions for reinfusing processed red blood cells under physician supervision.

Chapter 7: Automated Functions

Autostart Function

Automatically initiates the first Fill phase based on reservoir blood volume.

Continue Function

Allows automatic sequential processing of multiple cycles without operator intervention.

Last Bowl

Automates case conclusion by processing remaining blood and emptying the RBC line.

Double Volume Wash Function

Doubles the wash volume for a single cycle when a bowl cannot be completely filled.

Better Quality Wash (BQW) Function

Optimizes Wash phase using centrifuge accelerations and decelerations.

Better Empty

Solves incomplete bowl emptying by activating a further special Empty phase.

Chapter 8: Configuring XTRA

Configuration Mode

Accesses password-protected screen for general system configuration.

How to Enter the Configuration Mode

Provides steps to access the Configuration Mode Screen by entering a password.

Setting the Enabled Features

Explains how to enable/disable optional features from the Features tab.

Setting the Enabled Protocols

Allows configuration of available processing protocols (ATS, SEQ, Emergency, User).

Setting the Wakeup Configuration

Configures system's initial settings at power on, including ATS mode, Autostart, and Vacuum set points.

Setting the Rapid Selection of ID

Configures rapid selection of ID fields for use in the ID Tab of the Menu Screen.

Reset Options

Allows resetting machine configuration to factory defaults or deleting all cases from memory.

Chapter 9: Programmability Option

Enabling Programmability Option

Requires enabling "User Protocols" in Configuration Mode to create custom protocols.

Creating Custom Protocols

Guides on creating, modifying, and deleting custom protocols via the Protocol/Mode tab.

Creating a New Protocol

Step-by-step instructions for creating a new custom protocol by duplicating and customizing a base protocol.

Adjusting Parameters of a Protocol

Explains how to adjust protocol parameters at run time or from the Protocol/Mode tab.

Modifications Performed in the Protocol;Mode Tab

Details how to adjust programmable parameters via the Protocol/Mode tab.

Renaming a Protocol

Guides on renaming existing custom protocols using the Keyboard Screen.

Changing the Wakeup Protocol

Explains how to designate a protocol as the initially active protocol for new cases.

Deleting a Protocol

Guides on deleting existing custom protocols.

Chapter 10: Preoperative Sequestration (PPP and PRP)

Enabling the Preoperative Sequestration Protocols

Guides on enabling sequestration protocols via the Configuration Mode Screen.

Setup for Preoperative Sequestration

Outlines the setup differences for preoperative sequestration.

Running a Preoperative Sequestration Case

Covers running preoperative sequestration cases using dedicated SEQ protocols.

Loading the Pump Segment for a New Case

Guides on loading the pump loop tubing via the Setup Screen's Load button.

The Concentrate Cycle (With the PPP;PRP Protocols)

Used to complete bowl filling from the RBC bag or rewash RBC collection bag contents.

Finishing Preoperative Separation and Preparing for Blood Recovery

Steps to finish sequestration and prepare for blood recovery, including removing air and connecting lines.

Chapter 11: Data Download Option

Enabling Data Download Option

Requires enabling download methods in the Configuration Mode Screen Features tab.

Case Data Download

Explains where case data can be printed or downloaded from the interface.

Entering and Modifying Optional Case Data Fields

Guides on entering and modifying optional data fields in the ID tab.

Selecting Past Cases

Explains how to select past cases for display or saving from the End of Case or Tally tab.

Selecting the Output Device for Data Download

Guides on selecting the output destination for case data using a drop-down menu.

Sending Tallies to the Printer

Provides steps for printing current and past case data.

Sending Tallies to the XTRA USB Memory Device

Guides on saving current and past case data to a USB storage device.

Sending Tallies to the Stöckert Data Management System

Details steps for sending current and past case data to the Stöckert Data Management System.

Sending Tallies to a PC Through the RS232 Port

Explains PC connection requirements and data transmission via RS232 port.

Transferring Data From the Current Case

Steps for sending current case tally data to a PC via RS232 port.

Transferring Data From Past Cases

Steps for sending past case tally data to a PC via RS232 port.

Chapter 12: Quality Management Option

Enabling Quality Management Options

Explains that Hct, Supernatant Removal, and Waste Line Color indicators must be enabled.

Chapter 13: Vacuum Module

Setting Wakeup Values for Vacuum Module

Determines default vacuum mode and pressure set points based on last use or wakeup protocol.

Use of the XVAC System Through the XVAC Control Panel (Local Control)

Explains local control of the XVAC via its panel when XTRA interface is unavailable.

Chapter 14: Troubleshooting

Stop Button

A physical button to interrupt operations and return to the safe Ready Screen.

Alarms and Warnings During Setup

Lists warnings that may occur during the XTRA setup phase and their operator responses.

Equipment Malfunctions (Fatal Errors)

Describes fatal errors indicating unrecoverable hardware anomalies requiring technical intervention.

Chapter 15: Maintenance

Preventive Maintenance

Outlines regular maintenance checks by authorized service technicians.

Machine Repair

States that corrective maintenance must be performed by authorized Field Service Engineers.

Chapter 17: Warranty

Appendix C: Quick Operating Instructions

Setting Up the Disposables

Provides an overview of the operating procedures for setting up the disposables.

Setting the Active Protocol and Mode

Guides on setting the active protocol and operating mode via the Menu Screen.

Running an ATS Case

Provides an overview of running an ATS case, from disposable installation to case completion.

Running a PRP Sequestration Case

Provides an overview of running a PRP Sequestration case.

Creating a Custom Protocol

Provides an overview of creating a custom protocol.

Printing a Report for the Current Case

Illustrates printing a report from the Tally tab of the Menu Screen.

sorin XTRA Specifications

General IconGeneral
Brandsorin
ModelXTRA
CategoryMedical Equipment
LanguageEnglish

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