Endomedical Bravo User Manual

www.endomedical.ca
3
Information
Important Information .........................................................................
4
Specifications .........................................................................................6
Bravo™ Blood Glucose Monitoring System .........................................7
Bravo™ Blood Glucose Test Strip .........................................................8
Bravo™ Blood Glucose Meter ............................................................10
Bravo™ Blood Glucose Meter Display ...............................................11
Preparation
Setting up Your System .......................................................................
12
Adjusting the Date and Time ..........................................................................12
Setting the Sound On/OFF ...............................................................................15
Setting the ‘Test Result Reset’ .........................................................................16
Checking the System ...........................................................................17
Control Solution Testing ..................................................................................18
Comparing the Control Solution Test Results .................................................20
Testing
Using the Lancing Device ....................................................................
21
Preparing the Lancing Device ..........................................................................22
Preparing the Meter and Test Strip .................................................................24
Flagging Post-meal Test Results ......................................................................24
Applying Blood Sample ...................................................................................25
Discarding Used Lancets ..................................................................................27
Alternative Site Testing .......................................................................28
HI and Lo Messages .............................................................................31
Target Blood Glucose Ranges .............................................................32
Additional Functions
Meter Memory ....................................................................................
33
Viewing Test Results Stored in the Meter’s Memory......................................33
Setting the Alarm Function ................................................................35
Setting the Post-meal Alarm (PP2 alarm) .......................................................35
Setting the Time Alarm (alarm 1~3)................................................................36
Maintenance
Putting in or Replacing the Batteries .................................................
38
Caring for Your System .......................................................................39
Understanding Error and Other Messages ........................................40
General Troubleshooting ....................................................................42
Performance Characteristics ...............................................................43
Warranty Information .........................................................................47
TABLE OF CONTENTS

Endomedical Bravo Specifications

General

Brand	Endomedical
Model	Bravo
Category	Blood Glucose Meter
Language	English

Summary

Important Information

Intended Use and Limitations

Defines the Bravo™™ Blood Glucose Monitoring System's purpose and limitations for in vitro diagnostic use.

Key Symbols Explained

Explains important symbols found in the user manual, packaging, and product inserts.

Critical Safety Precautions

Lists essential safety advice and actions for abnormal glucose levels.

Product Specifications

Technical Specifications

Details measurement range, sample size, test time, power, memory, size, and weight.

Operating Environment Ranges

Specifies temperature, relative humidity, and hematocrit parameters for operation.

System Components List

Illustrates and lists all items included in the Bravo™™ Blood Glucose Monitoring System.

Bravo™™ Blood Glucose Test Strip

Test Strip Functionality

Explains how the test strip works, including contact bars and confirmation window.

Test Strip Usage Warnings

Provides critical warnings regarding test strip storage, expiration, and handling.

Measurement Unit Setting

Informs about the default unit (mmol/L) and how to change it.

Bravo™™ Glucose Meter Overview

Meter Key Components

Identifies meter parts like Data Port, S button, ▲/▼ buttons, and Test Strip Port.

Meter Display Indicators

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

Display Unit Confirmation

Confirms the meter is set to mmol/L and how to verify or change units.

System Setup and Configuration

Entering System Settings Mode

Instructions on how to access the meter's system setting menu.

Setting Date and Time

Step-by-step guide to set the year, month, date, and time on the meter.

Setting Hour and Minute

Detailed steps to set the hour and minute for the meter's time display.

Configuring Sound Alerts

Guide to enable or disable meter sound alerts and beep notifications.

System Checking Procedures

Resetting Test Results

Procedure to delete all stored test results from the meter's memory.

Control Solution Testing Guide

Instructions on using control solution to check meter and strip functionality.

Performing Control Solution Test

Step-by-step guide on how to conduct a control solution test for accuracy.

Comparing Control Solution Results

How to compare test results with the printed range and actions for out-of-range results.

Control Solution Result Comparison

Factors Affecting Control Results

Lists factors that can cause out-of-range control solution test results.

Using the Lancing Device

Lancing Device Parts

Identifies lancing device components like adjustable tip, lancet holder, and release button.

Lancing Device Safety Precautions

Safety for using the lancing device, including single-use lancets and site selection.

Lancing Device Preparation

Hand and Site Preparation

Instructions for washing hands and sample site before lancing.

Lancet Insertion and Cocking

Steps for inserting a new lancet and cocking the lancing device.

Selecting Skin Penetration Depth

Guide to selecting the appropriate skin penetration depth for the lancing device.

Meter and Test Strip Preparation

Inserting Test Strip into Meter

How to correctly insert the test strip into the meter's test strip port.

Flagging Post-Meal Test Results

How to mark a test result as post-meal using the specific icon.

Applying Blood Sample

Obtaining Blood Sample Drop

Procedure for obtaining a blood sample using the lancing device.

Applying Sample to Test Strip

Instructions for applying the blood sample to the test strip confirmation window.

Discarding Used Lancets

Safe Lancet Disposal

Step-by-step guide on how to safely dispose of used lancets.

Lancet Single-Use Warning

Emphasizes single-use lancets and avoiding sharing or reuse for safety.

Alternative Site Testing (AST)

Understanding AST

Explains Alternative Site Testing and its purpose for pain reduction.

Acceptable AST Scenarios

Lists times when AST is appropriate, such as fasting or before meals.

When Fingertip Testing is Required

Identifies scenarios where fingertip testing is mandatory for accuracy.

AST Precautions and Messages

AST Usage Guidelines

Provides precautions for AST, such as not ignoring symptoms and consulting professionals.

HI Message (Hyperglycemia)

Describes the 'HI' message for high blood glucose and recommended actions.

LO Message (Hypoglycemia)

Explains the 'LO' message for low blood glucose and required steps.

Blood Glucose Targets and Memory

Recommended Blood Glucose Ranges

Table showing target ranges based on time of day, from healthcare professionals.

Meter Memory Capacity

Details the meter's ability to store 250 results and how full memory is handled.

Viewing Meter Memory

Accessing Stored Test Results

Instructions to turn on the meter and view stored test results and averages.

Viewing Test Result Averages

How to navigate through average total, pre-meal, and post-meal test results.

Setting Alarm Functions

Overview of Alarm Types

Overview of the four alarm types: one post-meal and three time-set alarms.

Configuring Alarms

Setting the Post-Meal Alarm (PP2)

Steps to enable or disable the post-meal alarm (PP2) on the meter.

Setting Time-Based Alarms (1-3)

Guide to configure up to three time-set alarms on the meter.

Meter Maintenance and Care

Battery Replacement Procedure

Instructions for opening the compartment and replacing meter batteries.

System Cleaning and Storage

How to clean the meter exterior and store components safely.

Important Care Precautions

Lists important precautions for meter care, storage, and usage environment.

Understanding Error Messages

Error Code Explanations and Actions

Details common error messages (Er1-Er6) and the recommended actions.

Troubleshooting and Performance

General Troubleshooting Guide

Provides solutions for common issues like blank display, test failures, or inaccurate results.

Performance Accuracy Data

Presents accuracy data comparing the meter to a laboratory instrument.

Accuracy Metrics by Glucose Level

Specific accuracy metrics for glucose concentrations below and above 4.2 mmol/L.

Precision Studies

Within Run Precision Analysis

Details precision study results for single-run measurements.

Total Precision Analysis

Presents precision study results considering total variation.