Tyson Bio HT100-B User Manual

The Tyson Bio HT100-B Blood Glucose Test Strips give accurate results when the following limitations are observed.
˙Use only capillary whole blood from nger, palm, and forearm.
˙Do not use for testing neonatal blood.
˙Altitude higher than 10745 feet may cause inaccurate results.
˙Severe dehydration and excessive water loss may lead to inaccurate blood glucose test results.
Consult your physician immediately if you believe you are suering from severe dehydration.
˙For single-patient use only and should not be shared.
˙Should not be used to test critically ill patients.
˙Inaccurate results may occur in severely hypotensive individuals or patients in shock.
˙Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
˙For In vitro diagnostic only.
˙For over the counter use.
˙Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly).
˙Alternative site measurements should never be used to calibrate continuous glucose monitors (CGMs).
˙Alternative site measurements should never be used for insulin dosing calculations.
Limitations
Warning
•This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician
oces, or long-term care facilities because it has not been cleared by FDA for use in these settings,
including for routine assisted testing or as part of glycemic control procedures.
•Use of this device on multiple patients may lead to transmission of Human Immunodeciency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

Tyson Bio HT100-B Specifications

General

Brand	Tyson Bio
Model	HT100-B
Category	Blood Glucose Meter
Language	English

Summary

Limitations

General Limitations

Lists conditions affecting blood glucose test strip accuracy.

Important Warning

Device not for healthcare settings; risk of pathogen transmission.

Introduction

Intended Use Statement

Defines the system's purpose for quantitative glucose measurement and target users.

Important Safety Instructions

Infectious Hazard and Single-Use Policy

States all parts are potentially infectious and for single-person use only.

About the System

Kit Contents

Lists all items included in the complete blood glucose monitoring kit.

About the Blood Glucose Meter

Meter Components and Functions

Identifies and describes the functions of the meter's parts and buttons.

Meter Display Information

Understanding Display Icons and Indicators

Explains the meaning of various icons and indicators on the meter's display.

About the Test Strip

Test Strip Anatomy

Details the parts of the blood glucose test strip and their purpose.

Test Strip Vial Label Details

Storage and Usage Guidelines

Provides instructions for storing test strips and their usage conditions.

Setting Up the Meter

Installing Batteries and Configuring Date/Time

Guides on battery installation and setting the meter's date and time.

Setting Reminder Alarms

Instructions for setting the meter's 4 reminder alarms.

Configuring HI/LO Alarms

Instructions to set high and low blood glucose alert thresholds.

Important Information for Testing

Pre-Test Precautions and Usage

Essential steps and considerations before performing a blood glucose test.

Performing a Test

Preparing and Inserting the Test Strip

Steps for correctly preparing and inserting a test strip into the meter.

Obtaining a Blood Sample

Lancing Device Operation and Unloading

Instructions on using the lancing device and safely unloading used lancets.

Applying a Blood Sample

Test Procedure and Safety Warnings

How to apply blood, store results, and safety notes for strip handling.

High and Low Readings

Interpreting HI/LO Indicators

Explains what "HI" and "LO" readings signify on the meter display.

Alternate Site Testing (AST)

AST Guidelines and Limitations

Information on testing on palm/forearm, including when, when not to use, and limitations.

Control Solution Testing

When and How to Perform Control Test

Scenarios requiring control tests and step-by-step instructions.

Interpreting Control Solution Results

How to determine if control solution results are within the expected range.

Memory Features

Viewing Stored Test Results

How to access and navigate through recorded test results.

Day Average Results

Calculating and Displaying Averages

How to view 7, 14, and 30-day average glucose readings.

Exiting Modes and Data Transfer

Exiting Memory Mode and Recording Results

How to exit modes and use the log book for recording results.

Transferring Results to Computer

Instructions for connecting the meter to a PC for data transfer.

Bluetooth Data Transfer

Bluetooth Setup and Data Transfer

Steps to set up Bluetooth and transfer test results to a mobile device.

Bluetooth Connectivity

Connecting Before and After Testing

Procedures to enable Bluetooth connection before and after blood glucose tests.

Cleaning and Disinfection

Cleaning and Disinfecting the Meter

Procedures for cleaning and disinfecting the blood glucose meter.

Care and Storage

Handling and Storage Recommendations

Guidelines for properly handling and storing the meter and accessories.

Display Messages

System Status and Temperature Indicators

Explains messages for system readiness, temperature, and battery status.

Alarm and Low Battery Indicators

Explains messages for preset alarms and low battery status.

Error Messages

Temperature and Battery Related Errors

Details error codes related to temperature and battery issues.

Meter and Test Strip Related Errors

Details error codes indicating problems with the meter or test strips.

Troubleshooting

Common Operational Issues and Solutions

Addresses common problems like incorrect strip insertion or blank display.

Specifications

Technical Specifications

Provides detailed technical parameters of the blood glucose meter.

Meter Storage and Icon Guide

Storage Conditions

Specifies the recommended temperature and humidity for meter storage.

Icon Description

Explains the meaning of various symbols and icons used on the meter.

Service and Warranty

Important Compliance and Warranty Information

States compliance with regulations and outlines manufacturer warranty terms.

Regulatory Notices

FCC Statement and Interference

Details FCC regulations regarding device operation and potential interference.

RF Exposure Compliance

Information regarding the device's compliance with RF radiation exposure limits.