VivaChek Fad Sync - User Manual

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Blood Glucose Monitoring System
Dear VivaChek™ Fad Sync System User,
Thank you for choosing the VivaChek™ Fad Sync Blood Glucose Monitoring
System! VivaChek™ Fad Sync Blood Glucose Monitoring System is designed for
easy test of blood glucose and helps you keep blood glucose under control.
Read this User’s Manual carefully before you use your meter system. This manual
will help you to get comfortable using the VivaChek™ Fad Sync Blood Glucose
Monitoring System and get reliable test results. Please keep your User’s Manual in
a safe place; you may want to refer it in the future.
Thank you again for choosing the VivaChek™ Fad Sync System.
Intended Use and Principle
VivaChek™ Fad Sync Blood Glucose Monitoring System is comprised of the
VivaChek™ Fad Sync Blood Glucose Meter (VGM08) and the VivaChek™ Ino
Blood Glucose Test Strips (VGS01) and VivaChek™ Fad Blood Glucose Test
Strips (VGS02). The VivaChek™ Fad Sync Blood Glucose Monitoring System is
intended to quantitatively measure the glucose concentration in fresh capillary
whole blood samples drawn from the fingertips. It is intended for use by persons
with diabetes at home as an aid to monitor the effectiveness of diabetes control. It
is not intended for neonatal use or for the diagnosis of or screening for diabetes.
This system is intended for self-testing outside the body (in vitro diagnostic use)
and should only be used by a single person and should not be shared.
This meter is not intended for use in healthcare or assisted-use settings such as
hospitals, physician offices, 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 meter on multiple patients may
lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus
(HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

Summary

Introduction and System Overview

Intended Use and Principle

Defines the purpose and basic working principle of the VivaChek™™ Fad Sync Blood Glucose Monitoring System.

Understanding Your Testing Tools

Meter System Overview

Provides a visual and descriptive overview of the VivaChek™™ Fad Sync Blood Glucose Meter and test strips.

Meter Display Symbols

Details the symbols and icons displayed on the meter, explaining their meaning for user understanding.

System Usage Guidelines and Safety

Meter Use and Precautions

Outlines general guidelines, precautions, and best practices for using the blood glucose monitoring system.

Critical Safety Information

Highlights critical safety instructions, including single-patient use and handling precautions to prevent disease transmission.

System Limitations and Biohazard Risks

Lists the limitations of the system's use and emphasizes the biohazardous nature of kit components.

System Setup and Configuration

Setting the Clock and Date

Guides users through the process of setting the correct time and date on the glucose meter for accurate record-keeping.

Setting the Time and Audio Feature

Instructs users on how to adjust the meter's time and configure audio alerts for user preference.

Connectivity and Independent Use

Pairing and Syncing with iPhone App

Details the steps for pairing the meter with an iPhone and syncing data wirelessly using the VivaGuard™™ app.

Using the Meter Without the App

Describes how to use the blood glucose meter without connecting to a smartphone or app.

Performing Blood Glucose Tests

Preparing the Test Strip

Provides step-by-step instructions on how to correctly prepare and insert a test strip into the meter.

Preparing the Lancing Device

Guides users on how to assemble and adjust the lancing device for blood sample collection.

Test Execution and Sample Handling

Obtaining and Applying Blood Sample

Explains how to lance the finger, obtain blood, and apply it to the test strip for measurement.

Test Completion and Disposal

Covers the meter's countdown, result storage, and proper disposal of used test strips.

Advanced Testing and Reference Information

Alternative Site Testing (AST)

Details the procedure and considerations for collecting blood samples from sites other than the fingertip.

Glucose Reference Ranges

Provides expected blood glucose values for individuals without diabetes, categorized by time of day.

Ensuring Test Accuracy and Reliability

Addressing Inconsistent Results

Offers steps to troubleshoot and resolve questionable or inconsistent blood glucose test results.

Performing and Interpreting Control Tests

Explains the purpose, procedure, and interpretation of control tests to verify meter and strip performance.

Data Management and Review

Meter Memory and Viewing Results

Explains how the meter stores results and how to access and review stored blood glucose test data.

Maintenance and Troubleshooting

Recharging the Battery

Provides instructions on how to recharge the meter's battery using various connection options and safety cautions.

System Care and Disinfection

Offers advice on system care and details the weekly cleaning and disinfection procedures for the meter.

Troubleshooting and Error Resolution

Troubleshooting Meter Error Codes

Explains common error codes (E1-E9, HI, LO) displayed by the meter and provides recommended solutions for each.

Understanding Blood Glucose Levels

Symptoms of High and Low Blood Glucose

Lists common symptoms associated with hypoglycemia (low blood glucose) and hyperglycemia (high blood glucose).

Technical Specifications and Warranty

System Specifications and Accuracy Data

Details the technical features, operational parameters, and accuracy performance of the VivaChek™™ Fad Sync Blood Glucose Monitoring System.

Product Warranty Information

Outlines the warranty terms and conditions for the VivaChek™™ Fad Sync Blood Glucose Monitoring System.

VivaChek Fad Sync Specifications

General

Product Type	Blood Glucose Meter
Connectivity	Bluetooth
Display	LCD
Test Time	5 seconds
Sample Type	Capillary whole blood
Operating Humidity	10-90% RH
Sample Size	0.5 µL
Measurement Range	20-600 mg/dL