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Haemonetics Cell Saver Elite+ - User Manual

Haemonetics Cell Saver Elite+
230 pages
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User Manual
Not for use with software
prior to revision AQ
130859-US(AA)
October 2022

Table of Contents

Other manuals for Haemonetics Cell Saver Elite+

Questions and Answers

Summary

Publication Information

Copyright and Proprietary Notices

Describes copyright, reproduction, and reverse engineering prohibitions.

Disclaimer and Document Updates

Covers manual's purpose, liability, and change policy.

Trademarks, Legal Restrictions, and Contact Information

Lists trademarks, Rx Only status, and worldwide contacts.

Introduction to Cell Saver Elite+

Device and System Overview

Introduces the device, system, purpose, and indications for use.

Essential Performance, Contraindications, and Features

Details core performance, usage restrictions, and system capabilities.

Performance Characteristics and Specifications

Outlines performance data, vacuum suction, and protocol specs.

Blood Product Quality Criteria and Test Results

Presents quality control criteria and test outcomes.

Document and Device Symbols

Explains symbols used in the manual and on the device.

Device Specifications and Components

Device Classification and Physical Characteristics

Details classification, dimensions, weight, and environmental needs.

Electrical and Laser Specifications

Covers electrical input, leakage, and laser parameters.

Ordering Information and Replaceable Parts

Lists disposable components and user-replaceable parts.

Equipment Description

System Overview and Major Components

Introduces the chapter and main system parts.

Front Panel and Top Deck Components

Describes device cover, sensors, pump, and handle.

Valve Module and Centrifuge System

Details the valve module and centrifuge components.

Rear and Side Panel Components

Describes rear/side panel parts like power entry and connections.

User Interface Elements

Covers touch screen, status beacon, barcode reader, and keys.

GUI Navigation and Control Pads

Explains GUI, status indicators, suction, menu, and phase pads.

Device Settings and System Configuration

Details accessing and managing device settings.

Cart Components and Assembly

Describes cart parts and how to install the device.

Disposable Components Description

Disposable Component Overview

Introduces available single-use components.

Reservoir, A&A Line, and Vacuum Line

Describes key fluid collection and transfer components.

Processing Set Elements, Bags, and Centrifuge Bowl

Details tubing, bags, and the centrifuge bowl.

Sequestration Set Details

Describes the components of the sequestration set.

Safety and Patient Care Precautions

Device Handling, Storage, and Inspection

Covers proper procedures for device and component management.

Transporting the Device and Patient Care Safety

Provides transport guidelines and patient safety alerts.

General User Warnings and Hazards

Lists electrical, laser, mechanical, and communicable disease hazards.

Preventing Procedure Problems and Hemolysis Risks

Offers advice on avoiding issues like hemolysis and flow restrictions.

Reinfusion Precautions and Anticoagulant Use

Details critical warnings for reinfusion and anticoagulant management.

Factors Affecting Processing Time

Lists factors influencing cell salvage and sequestration times.

General Operation: Cell Salvage

Initial Device Preparation and Setup

Covers connecting power, positioning, and waste bag setup.

Component Installation for Cell Salvage

Guides installing processing sets, tubing, and the bowl.

Connecting Reservoir and Setting up Saline

Details connecting the reservoir and saline solution.

Intraoperative Procedure Steps and Functions

Explains initiating, phases, and additional functions.

Emergency and Manual Operation Modes

Details Emergency Mode, Quick Transfer, and Manual Mode.

Procedure Completion and Record Keeping

Guides ending procedures and accessing records.

General Operation: Sequestration

Initial Device Preparation for Sequestration

Covers power, positioning, and waste bag setup.

Sequestration Component Installation

Guides installing sequestration components.

Performing a Sequestration Procedure

Details initiating and executing the sequestration process.

Collecting Plasma Fractions and Emptying Bowl

Explains collecting PPP, PRP, and emptying the bowl.

Ending, Changing, and Completing Sequestration

Guides ending early, switching to Cell Salvage, and completing cycles.

Reinfusion Precautions and Product Removal

Lists precautions for RBC reinfusion and plasma product removal.

Protocol Settings

Working with Settings Groups

Covers creating, editing, locking, applying, and deleting settings groups.

Cell Salvage and Sequestration Default Settings

Lists default parameters for both protocols.

Enabling Quick Transfer and Manual Mode

Guides enabling advanced operational modes.

Records Management

Overview and Procedure Records

Introduces the records section and details procedure records.

Managing Disposables and Events Data

Covers adding, editing, deleting disposables and viewing events.

Device Records and Exporting Data

Details device information and exporting records.

Help System Navigation

Help System Overview and Access

Introduces the help system features and how to access it.

Navigating Help Menus and Performing Searches

Guides browsing topics and searching for keywords.

Cleaning and Maintenance

Cleaning Procedures and Supplies

Covers cleaning schedules, supplies, and exterior surface cleaning.

Device Component Cleaning

Details cleaning optical lenses, centrifuge well, fluid detector, and pump.

Filter Maintenance and Fuse Replacement

Covers air filter maintenance and fuse replacement.

Power Cord Inspection and Customer Service

Details power cord checks and customer support contacts.

Troubleshooting Common Issues

Vacuum and Air Flow Problems

Addresses issues with vacuum and air flow/aspiration.

Touch Screen and Device Cover Issues

Covers problems with touch screen responsiveness and cover locking.

Event Messages and Troubleshooting Scenarios

Lists event messages and their corrective actions.

IEC;EN 60601-1-2 Standard Requirements

Operation Precautions and Electromagnetic Compatibility

Details operational considerations for EMC and safety.

System Performance Data

Cell Salvage Performance Metrics

Presents data on HCT, RBC recovery, and washouts for different modes.

Cart Assembly Instructions

Installing the Device onto the Cart

Provides step-by-step visual guide for cart assembly.

Summary

Publication Information

Copyright and Proprietary Notices

Describes copyright, reproduction, and reverse engineering prohibitions.

Disclaimer and Document Updates

Covers manual's purpose, liability, and change policy.

Trademarks, Legal Restrictions, and Contact Information

Lists trademarks, Rx Only status, and worldwide contacts.

Introduction to Cell Saver Elite+

Device and System Overview

Introduces the device, system, purpose, and indications for use.

Essential Performance, Contraindications, and Features

Details core performance, usage restrictions, and system capabilities.

Performance Characteristics and Specifications

Outlines performance data, vacuum suction, and protocol specs.

Blood Product Quality Criteria and Test Results

Presents quality control criteria and test outcomes.

Document and Device Symbols

Explains symbols used in the manual and on the device.

Device Specifications and Components

Device Classification and Physical Characteristics

Details classification, dimensions, weight, and environmental needs.

Electrical and Laser Specifications

Covers electrical input, leakage, and laser parameters.

Ordering Information and Replaceable Parts

Lists disposable components and user-replaceable parts.

Equipment Description

System Overview and Major Components

Introduces the chapter and main system parts.

Front Panel and Top Deck Components

Describes device cover, sensors, pump, and handle.

Valve Module and Centrifuge System

Details the valve module and centrifuge components.

Rear and Side Panel Components

Describes rear/side panel parts like power entry and connections.

User Interface Elements

Covers touch screen, status beacon, barcode reader, and keys.

GUI Navigation and Control Pads

Explains GUI, status indicators, suction, menu, and phase pads.

Device Settings and System Configuration

Details accessing and managing device settings.

Cart Components and Assembly

Describes cart parts and how to install the device.

Disposable Components Description

Disposable Component Overview

Introduces available single-use components.

Reservoir, A&A Line, and Vacuum Line

Describes key fluid collection and transfer components.

Processing Set Elements, Bags, and Centrifuge Bowl

Details tubing, bags, and the centrifuge bowl.

Sequestration Set Details

Describes the components of the sequestration set.

Safety and Patient Care Precautions

Device Handling, Storage, and Inspection

Covers proper procedures for device and component management.

Transporting the Device and Patient Care Safety

Provides transport guidelines and patient safety alerts.

General User Warnings and Hazards

Lists electrical, laser, mechanical, and communicable disease hazards.

Preventing Procedure Problems and Hemolysis Risks

Offers advice on avoiding issues like hemolysis and flow restrictions.

Reinfusion Precautions and Anticoagulant Use

Details critical warnings for reinfusion and anticoagulant management.

Factors Affecting Processing Time

Lists factors influencing cell salvage and sequestration times.

General Operation: Cell Salvage

Initial Device Preparation and Setup

Covers connecting power, positioning, and waste bag setup.

Component Installation for Cell Salvage

Guides installing processing sets, tubing, and the bowl.

Connecting Reservoir and Setting up Saline

Details connecting the reservoir and saline solution.

Intraoperative Procedure Steps and Functions

Explains initiating, phases, and additional functions.

Emergency and Manual Operation Modes

Details Emergency Mode, Quick Transfer, and Manual Mode.

Procedure Completion and Record Keeping

Guides ending procedures and accessing records.

General Operation: Sequestration

Initial Device Preparation for Sequestration

Covers power, positioning, and waste bag setup.

Sequestration Component Installation

Guides installing sequestration components.

Performing a Sequestration Procedure

Details initiating and executing the sequestration process.

Collecting Plasma Fractions and Emptying Bowl

Explains collecting PPP, PRP, and emptying the bowl.

Ending, Changing, and Completing Sequestration

Guides ending early, switching to Cell Salvage, and completing cycles.

Reinfusion Precautions and Product Removal

Lists precautions for RBC reinfusion and plasma product removal.

Protocol Settings

Working with Settings Groups

Covers creating, editing, locking, applying, and deleting settings groups.

Cell Salvage and Sequestration Default Settings

Lists default parameters for both protocols.

Enabling Quick Transfer and Manual Mode

Guides enabling advanced operational modes.

Records Management

Overview and Procedure Records

Introduces the records section and details procedure records.

Managing Disposables and Events Data

Covers adding, editing, deleting disposables and viewing events.

Device Records and Exporting Data

Details device information and exporting records.

Help System Navigation

Help System Overview and Access

Introduces the help system features and how to access it.

Navigating Help Menus and Performing Searches

Guides browsing topics and searching for keywords.

Cleaning and Maintenance

Cleaning Procedures and Supplies

Covers cleaning schedules, supplies, and exterior surface cleaning.

Device Component Cleaning

Details cleaning optical lenses, centrifuge well, fluid detector, and pump.

Filter Maintenance and Fuse Replacement

Covers air filter maintenance and fuse replacement.

Power Cord Inspection and Customer Service

Details power cord checks and customer support contacts.

Troubleshooting Common Issues

Vacuum and Air Flow Problems

Addresses issues with vacuum and air flow/aspiration.

Touch Screen and Device Cover Issues

Covers problems with touch screen responsiveness and cover locking.

Event Messages and Troubleshooting Scenarios

Lists event messages and their corrective actions.

IEC;EN 60601-1-2 Standard Requirements

Operation Precautions and Electromagnetic Compatibility

Details operational considerations for EMC and safety.

System Performance Data

Cell Salvage Performance Metrics

Presents data on HCT, RBC recovery, and washouts for different modes.

Cart Assembly Instructions

Installing the Device onto the Cart

Provides step-by-step visual guide for cart assembly.

Haemonetics Cell Saver Elite+ Specifications

General IconGeneral
Power Supply100-240 VAC, 50/60 Hz
User InterfaceTouchscreen display
Automated ProcessingYes
Relative Humidity20% to 80%, non-condensing
Data ManagementData logging and reporting
AnticoagulantCitrate
Wash VolumeAdjustable
Bowl Size125 mL, 225 mL
Processing TimeTypically 3-5 minutes per cycle
Operating Temperature10°C to 40°C
Storage Temperature-20°C to 60°C (-4°F to 140°F)
CategoryIntraoperative Blood Recovery System

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