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Abbott FreeStyle Optium Neo H User Manual

Abbott FreeStyle Optium Neo H
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Operators
Manual
Blood Glucose and Ketone Monitoring System

Questions and Answers:

Abbott FreeStyle Optium Neo H Specifications

General IconGeneral
Test Time5 seconds
Sample Size0.6 μL
Battery Type2 x CR2032 coin cell batteries
Sample TypeCapillary whole blood
DisplayLCD
Measurement Range1.1 to 27.8 mmol/L
Operating Conditions10°C to 40°C

Summary

Symbols Reference

General Symbol Definitions

Explains common symbols like consult instructions, temperature, manufacturer, and regulatory marks.

Specific Symbol Definitions

Defines symbols for batch code, date of manufacture, UDI, and battery directive.

Intended Use

System Overview and Purpose

Describes the meter, its intended use for quantitative measurement of glucose and ketones.

Sample and Usage Guidelines

Details sample types, strip compatibility, and restrictions for meter usage.

Important Precautions and Safety

Covers safety, infection risk, reading instructions, and handling with children.

How the System Works

Explains the process of measuring glucose or ketone via test strip reaction.

Package Contents and Materials

Lists included items and necessary materials not provided with the meter.

Meter Overview

Device Components and Ports

Details the display, ports, and buttons of the meter.

Test Strip Insertion Area

Explains where to insert the test strip and the target area for sample application.

Logbook Access Functionality

Explains how to access the meter's logbook feature.

Meter Symbols Reference

Logbook and Test Status Symbols

Symbols for logbook, meter ready, control solution, and ketone tests.

Indicator and Mode Symbols

Symbols for out-of-range indicators, setup mode, and battery status.

Blood Test and Control Symbols

Symbols related to venous blood tests and control solution testing.

Using the Meter

Powering the Meter On and Off

Instructions on how to power the meter on and off using buttons or strip insertion.

Initial Meter Screen Check

Guidance on verifying the meter screen during startup for proper function.

Setting Up the Meter

Setting the Time and Date

Comprehensive guide to setting the meter's time and date parameters accurately.

Configuring Meter Alerts

Setting Out-of-Range Indicators

Step-by-step guide to setting low and high glucose thresholds for alerts.

Enabling Quality Control Reminders

Instructions for setting up periodic reminders for quality control tests.

Preparing for Testing

Meter Calibration Process

Detailed steps for calibrating the meter using the provided calibrator.

Calibrator Usage and Verification

How to insert the calibrator and verify the LOT number match.

Confirming the LOT Number

LOT Number Matching Verification

Explains where to check the LOT number and what to do if it doesn't match.

Performing a Test

Test Site Preparation and Strip Insertion

Guidance on selecting sites, preparing, and inserting test strips.

Blood Sample Application

Detailed steps for applying the blood sample to the test strip and the countdown.

Result Display and Meter Shutdown

How to view results and properly turn off the meter after testing.

Neonatal Heel Stick Sample

Heel Stick Sample Collection

Procedures for collecting blood samples from a neonatal heel.

Sample Application Techniques

Methods for applying the collected blood to the test strip.

Understanding Blood Glucose Results

Glucose Result Interpretation

Explains units, ranges, and the significance of low/high glucose readings.

Low Blood Glucose Indicators

Explains the meaning of the red arrow and "LO" display for low glucose.

High Blood Glucose Results

High Glucose Indicators Explained

Explains yellow arrow, "KET" blinking, and "HI" display for high glucose.

Actions for High Glucose

Steps to take when high blood glucose results are observed.

Understanding Ketone Results

Ketone Measurement Range and Values

Details the expected range and units for blood ketone measurements.

Interpreting High Ketone Levels

Explains high ketone readings and what they signify, including DKA risk.

Logbook and Data Viewing

Viewing Logbook Events

Instructions for accessing and reviewing stored test results and events.

Viewing Glucose Averages

How to view and interpret 7, 14, and 30-day blood glucose averages.

Performing Control Tests

Control Test Procedure Steps

Step-by-step guide for performing control solution tests.

Interpreting Control Results

How to view and check if control solution results fall within the expected range.

Transferring Meter Data to Computer

Data Transfer Requirements and Safety

Lists necessary items for data transfer and safety warnings.

Troubleshooting Errors

Temperature and Meter Errors

Explains error codes E-1 and E-2 and their solutions.

Sample, Procedure, and Strip Errors

Covers errors E-3, E-4, E-5, E-6, E-7, and E-9 and their resolutions.

Meter Maintenance

Battery Replacement Procedure

Detailed steps for safely replacing the meter's batteries.

Battery Notes and Disposal

Important information on battery installation, settings, and proper disposal.

Cleaning the Meter

Cleaning Supplies and Procedure

Lists required supplies and steps for cleaning the meter's exterior.

Important Cleaning Precautions

Warnings against submerging the meter or getting liquids in ports.

Troubleshooting Common Issues

Meter and Test Strip Problems

Solutions for insertion, battery, connection, and general strip/meter issues.

Test Start Failures

Addresses issues preventing the test from starting after sample application.

Meter Specifications

Technical Performance Metrics

Details assay method, shutoff, measurement range, memory, and computer requirements.

Physical and Environmental Specs

Covers power source, size, temperature, weight, and EMC information.

Reporting Serious Incidents

Incident Reporting Procedure

How to report serious incidents to Abbott Diabetes Care and authorities.

Definition of Serious Incident

Clarifies what constitutes a serious incident for reporting purposes.

Warranty Statement

Limited Warranty Coverage Details

Details the 2-year warranty period and Abbott's obligations.

Warranty Exclusions and Disclaimers

Outlines what is not covered by the warranty and legal disclaimers.

Limitation of Liability

Liability Limitations and Exclusions

States Abbott's liability limits for incidental or consequential damages.

Jurisdictional Liability Variations

Notes that local laws may affect warranty and liability exclusions.

Customer Contact and Distribution Info

Abbott Contact Information by Region

Provides contact details for Abbott Diabetes Care in various regions.

Distribution and Trademark Information

Lists distributors and trademark ownership information.

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