EasyManua.ls Logo

Abbott i-STAT Alinity - User Manual

Abbott i-STAT Alinity
296 pages
Print Icon
To Next Page IconTo Next Page
To Next Page IconTo Next Page
Loading...

Table of Contents

Other manuals for Abbott i-STAT Alinity

Question and Answer IconNeed help?

Do you have a question about the Abbott i-STAT Alinity and is the answer not in the manual?

Abbott i-STAT Alinity Specifications

General IconGeneral
Sample TypeWhole blood, plasma, serum
Humidity10% to 90% non-condensing
Device TypePoint-of-care analyzer
ConnectivityWi-Fi, Ethernet, USB
Power SourceRechargeable lithium-ion battery, AC adapter
Operating Temperature15°C to 30°C
DisplayTouchscreen LCD
Test CartridgesSingle-use cartridges
Sample Volume17-95 µL depending on test
Time to Results2 to 10 minutes
Regulatory ApprovalsFDA, CE Mark
Battery LifeApprox. 8 hours

Summary

Foreword

i-STAT ALINITY INSTRUMENT - END USER LICENSE AGREEMENT

Regulatory compliance

Safety Regulations

Details safety regulations for electrical equipment and battery use across different regions.

EMC Regulations

Outlines electromagnetic compatibility regulations for the i-STAT Alinity system.

Radio;Telecommunication Regulations

Lists country-specific radio and telecommunication regulations and type approvals.

1.1 - Complete i-STAT Alinity System Overview

i-STAT Alinity System Components

Describes the main components of the i-STAT Alinity system, including instrument, base station, and accessories.

1.2 - i-STAT Alinity Instrument

Intended Use

Specifies the intended use of the i-STAT Alinity instrument for in vitro diagnostic testing.

Principles of Operation

Explains the operational principles of the i-STAT Alinity instrument's subsystems.

More Options

Details the selections and information available via the "More Options" button on the instrument.

1.3 - i-STAT Alinity Results Screen

Interpreting Results

Explains how to interpret various analyte results, including calculated and suppressed values.

1.4 - i-STAT Alinity Rechargeable Battery

Overview

Introduces the Lithium-Ion rechargeable battery as the instrument's power source.

Description

Explains how the battery enables testing, recharges, and indicates battery level.

1.5 - i-STAT Alinity Base Station

Overview

Describes the primary function of the Base Station for charging the battery.

Description

Lists the functions of the Base Station, including charging, powering, and connectivity.

1.6 - i-STAT Alinity Electronic Simulator

Overview

Describes the Electronic Simulator as a quality control device for instrument evaluation.

Principles of Operation

Explains how the Electronic Simulator verifies electronic and thermal functionality.

1.7 - Perform Electronic Simulator Testing

1.8 - i-STAT Alinity Printer

Overview

Introduces the portable printer for printing test results and quality control information.

Principles of Operation

Details the process for printing patient results wirelessly or via the Base Station.

1.9 - Manufacturers Quality System Instructions

1.10 - Liquid Quality Controls

i-STAT Controls and i-STAT TriControls

Describes aqueous-based control solutions for verifying cartridge integrity.

Storage

Provides guidelines for storing control solutions refrigerated or at room temperature.

1.11 - Calibration Verification (Cal Ver)

Calibration Verification Testing and Solutions

Explains the procedure for verifying instrument calibration stability and reagent lot impact.

1.12 - i-STAT Cartridges

Overview

Describes i-STAT cartridges containing test reagents for generating results.

Cartridge Specifications

Details shelf life, preparation, and storage requirements for i-STAT cartridges.

1.13 - Software Updates

Software Update and Installation using USB memory device via Base Station

Provides a step-by-step guide for updating instrument software using a USB memory device.

Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wired Network Connection

Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wireless Network Connection

2.1 - AlinIQ NCi - Network Connectivity for i-STAT

Before beginning

Lists prerequisites and IT department involvement needed for network configuration.

Have available

Lists required equipment and software for network configuration.

Installing NCi

AlinIQ NCi - General Section

Configuration Name

Specifies how to name the network configuration file for instruments.

AlinIQ NCi - Proxy Server Connection

AlinIQ NCi - Wireless Network Connection

Network Name (SSID)

Defines the name of the wireless local area network (WLAN).

Authentication Type

Controls WPA type, authentication method, and cipher types for wireless security.

AlinIQ NCi - Wired Network Connection

AlinIQ NCi - Save the Network Connectivity (ancc) file

AlinIQ NCi - Copy NC (ancc) file onto a USB memory stick

AlinIQ NCi - Upload an NC (ancc) file to an instrument

AlinIQ NCi - Customization and Connectivity

AlinIQ NCi - Determining Success or Failure

Network Connectivity for i-STAT Alinity Worksheet

3.1 - AlinIQ CWi - Customization Workspace for i-STAT

Workspaces

Describes the three workspaces within CWi: Manage Profiles, Manage Users, Manage Organization.

3.2 - Manage Healthcare Organization

Overview - Healthcare Organization

Defines the Healthcare Organization identifier and the role of the Primary Manager.

3.3 - Manage Users

Overview

Explains user roles and permissions within the CWi application.

Best Practices

Provides recommendations for defining users and managing HCO managers.

3.4 - Manage and Assemble Profiles

Creating a Category

Guides the user through the process of creating a category for profile customization.

Category Index

Lists required and optional categories used for building instrument profiles.

*Quality Settings Category

Electronic Simulator

Configures settings for the Electronic Simulator testing schedule.

QC Notifications

Sets up how the instrument responds to quality control testing results.

Cal Ver Test Settings

Configures settings for calibration verification test acceptability and results display.

Cartridge Lot QC Settings

Configures user-defined cartridge QC settings for compliance and lot number management.

Liquid QC (Quality Control) Schedules

Defines a liquid quality control testing schedule, including frequency and timing.

User Defined Message Category

Training Settings Category

Basic Functions

Controls access to training mode and workspace for creating training scenarios.

Training Scenarios

Allows creation of user-defined training scenarios for consistent operator learning.

STATNotes Category

Items

Explains how to build STATNotes using items, sets, and predefined items.

Result Notes Category

Data Entry

Describes creating a Data Entry item to prompt for information via keypad or scanning.

Selection List

Guides creating a list of items for operator selection.

Selection List with Text box

Explains creating lists with text boxes for customized operator responses.

Repeat Test Item

Prompts the operator to answer "Yes" or "No" if a repeat test is needed.

Action Range Comment

Prompts the operator to select a comment for patient results within the action range.

QC Auto Fail Comment

Applies a comment when QC Pass/Fail determination is set to Auto via eVAS.

Manage Sets

Describes creating Result Notes sets from available Result Notes items.

Create Result Notes

Guides the creation of result notes sets for patient or control pathways.

Connectivity Settings Category

Connectivity Map

Configures connections to remote systems for data transmission and reception.

Assemble a Profile

Related product manuals