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NIPRO Diagnostics True Metrix Pro User Manual

NIPRO Diagnostics True Metrix Pro
63 pages
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(using TRUE METRIX
®
PRO Test Strips with GDH-FAD Enzyme)
For assistance please call:
Customer Care 1-800-803-6025
www.niprodiagnostics.com
Professional Monitoring
Blood Glucose System
© 2015 Nipro Diagnostics, Inc. TRUE METRIX, TRUEmanager and the Nipro Diagnostics logo are trademarks of Nipro Diagnostics, Inc. MKT0523 Rev. 2
*TRUE METRIX is intended for self-monitoring blood glucose only and not for multiple patient use. Only TRUE METRIX PRO is intended for multiple-patient use.
Comprehensive Resource Guide
for Healthcare Professionals
(Policies, Processes, and Procedures)
Information in this guide is specific
for healthcare professionals using the
TRUE METRIX
®
PRO Professional
Monitoring Blood Glucose System*
in a multiple-patient clinical setting.
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NIPRO Diagnostics True Metrix Pro Specifications

General IconGeneral
BrandNIPRO Diagnostics
ModelTrue Metrix Pro
CategoryBlood Glucose Meter
LanguageEnglish

Summary

Introduction to TRUE METRIX PRO System

Understanding System Use, Safety, and Testing

Covers intended use, safety information, and testing methods for the system.

System Components and Design Features

Reviews system components and key design features of the blood glucose monitoring system.

Clinical Performance and White Papers

Examines clinical white papers on proven product performance and accuracy.

Limitations and Interfering Substances

Reviews system limitations, including physiological and pharmacological interfering substances.

Blood Glucose Testing Process

Details the process for performing blood glucose testing using various specimens.

Quality Control, Maintenance, and Storage

Covers processes for quality control, product maintenance, and system operating conditions.

Diabetes Data Management Options

Discusses selecting diabetes data management options for data retrieval and management.

Staff Training Program Overview

Outlines a training program for staff focused on safe use of the product in a clinical setting.

Intended Use Statement

Safety Guidelines and Precautions

General Safety Precautions and Best Practices

Adheres to standard precautions, uses auto-disabling lancing devices, and avoids test strip reuse.

Cleaning and Disinfection Procedures

Details meter cleaning and disinfection to prevent pathogen transmission, using specific wipes.

EMC Safety Information

Addresses electromagnetic immunity and emission requirements for meter operation.

System Specifications

Meter Specifications Overview

Lists meter specifications including result range, sample size, test time, and battery life.

Chemical Composition of Test Strips and Control Solution

Details the chemical composition of TRUE METRIX PRO Test Strips and Control Solution.

Operating Conditions

Specifies the system's operating ranges for temperature, humidity, hematocrit, and altitude.

CLIA Requirements

System Components

TRUE METRIX PRO Meter

Visual representation of the TRUE METRIX PRO meter used for blood glucose testing.

TRUE METRIX PRO Test Strip Vial

Displays the vial containing TRUE METRIX PRO Test Strips for blood glucose monitoring.

TRUE METRIX PRO Test Strips

Shows the individual TRUE METRIX PRO Test Strips used with the glucose meter.

TRUE METRIX Control Solution Levels

Illustrates the three levels of TRUE METRIX Control Solution for system calibration.

Meter Key Features

Meter Design Elements

Meter Display Screen Explained

Test Strip Design and Technology

Control Solution Usage and Handling

Performance Characteristics for Healthcare Professionals

ISO 15197:2003 Accuracy Standards

Outlines the ISO accuracy standards for blood glucose monitoring systems.

Fingertip Capillary Blood Accuracy

Presents accuracy data for TRUE METRIX PRO fingertip capillary blood results compared to YSI.

Forearm Capillary Blood Accuracy

Shows accuracy data for TRUE METRIX PRO forearm capillary blood results compared to fingertip.

Precision and Venous Blood Accuracy

Limitations of Use for TRUE METRIX PRO

General Usage Restrictions and Precautions

Lists general limitations, including not sharing meters and proper storage of supplies.

Specific Testing Limitations and Patient Considerations

Covers limitations for specific patient groups, critically ill, and factors affecting results like altitude and hematocrit.

Drug and Substance Interactions

Details limitations regarding drug interactions, ascorbic acid, and uric acid interference.

Interference Testing Results

Meter Setup Procedures

Setting Up Time and Date

Step-by-step guide for setting the time and date on the TRUE METRIX PRO meter.

Setting Event Tags, Ketone Alert, and Test Reminders

Configuration of event tags, ketone alerts, and test reminders for the meter.

Quality Control Testing

Understanding Control Solution Levels

Explains the three levels of control solution used for quality control testing.

Quality Control Test Schedule and Guidelines

When to perform control tests, including before first use and after opening new strips.

How to Perform a Control Test

Detailed procedure for performing a control test using the TRUE METRIX PRO System.

Quality Control Testing Data Form

Blood Glucose Testing Procedure

Type of Blood Sample Information

Recommends capillary fingertip/forearm blood and discusses venous blood sample collection.

How to Perform a Blood Glucose Test

Step-by-step instructions for performing a blood glucose test using the TRUE METRIX PRO system.

Blood Glucose Testing Steps

Memory Features

Viewing Averages (7-, 14-, and 30-Day)

How to view average blood glucose results over different time periods in the meter's memory.

Viewing Test Results in Memory

Instructions for accessing and scrolling through stored test results in the meter's memory.

Diabetes Management Software

TRUEmanager Diabetes Management Software Overview

Introduces TRUEmanager software for managing blood glucose results and patient data.

Nipro Meter Software Compatibility

Shows compatibility of TRUEmanager software with Nipro meters and its installation media.

Diabetes Management Software Details

HL7 Interface Overview

Explains the HL7 interoperability module for data exchange with Electronic Medical Records.

TRUEmanager PRO Minimum Hardware and Software Requirements

Lists the minimum hardware and software requirements for installing TRUEmanager PRO on a client PC.

TRUEmanager Home Version Requirements

TRUEmanager Home Version Minimum Hardware and Software Requirements

Details the hardware and software requirements for the TRUEmanager Home version.

Troubleshooting Common Errors

Meter Does Not Turn On

Addresses issues when the meter does not turn on after test strip insertion.

Test Does Not Start or Meter Does Not Begin Testing

Troubleshoots issues where the test fails to start after sample application.

Troubleshooting Display Messages

Battery Replacement Guide

Cleaning and Disinfection

To Clean and Disinfect the Meter

Step-by-step guide for cleaning and disinfecting the TRUE METRIX PRO meter between uses.

System Storage Guidelines

TRUE METRIX PRO System Storage

Guidelines for storing the meter, control solution, and test strips to protect them.

TRUE METRIX PRO Test Strips Storage

Proper storage instructions for TRUE METRIX PRO test strips, including dating opened vials.

TRUE METRIX Control Solution Storage

Guidelines for storing TRUE METRIX Control Solution, including dating and temperature requirements.

Training Program Overview

Certificate Information

Details on the training certificate provided by Nipro Diagnostics for system use.

Certified Trainer Qualifications

Requirements and qualifications for becoming a Certified Trainer for the TRUE METRIX PRO System.

Approved Tester Qualifications

Requirements for personnel to become Approved Testers of the TRUE METRIX PRO System.

TRUE METRIX PRO Blood Glucose System Training Program Information

Training Session Preparation

Product Training Agenda (example)

An example agenda outlining topics, time estimates, and sources for training sessions.

Materials Checklist for Training

A list of materials required for conducting blood glucose and control testing training sessions.

Training Checklist for Personnel

Facility Personnel Training Completion

Checklist for confirming facility personnel have completed required reading and familiarization.

Facility Personnel Understanding Verification

Checklist to verify facility personnel's understanding of system use, specifications, and safety.

System Components Familiarization

Checklist to confirm familiarity with meter, test strips, and control solution components.

Training Checklist Details

Quality Control Tests Training

Checklist items covering understanding of quality control testing procedures and troubleshooting.

Blood Collection Training

Checklist items for understanding blood collection techniques, sample types, and facility procedures.

Blood Glucose Testing Demonstration

Checklist items for demonstrating proper blood glucose testing procedures and interpreting results.

Patient Blood Glucose Test Results Handling

Checklist for proper documentation, memory use, and biohazard disposal related to test results.

System Care, Cleaning, Disinfection, and Storage

Checklist for understanding meter care, cleaning, disinfection, battery replacement, and storage procedures.

Training Post Test

True or False Questions

True/False questions to assess understanding of the TRUE METRIX PRO System training material.

Multiple Choice Questions

Multiple choice questions to evaluate knowledge of the TRUE METRIX PRO System's features and procedures.

Training Post Test Answer Key

References

Test Strip Safety Data Sheet

Control Solution Safety Data Sheet

Quality Control Testing Data Form

Proficiency Testing Information

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