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Rightest GM700 Pro 2 - User Manual

Rightest GM700 Pro 2
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101-3GM762-XXX
EN(US)
Rev. Date: 2021-01
User’s Manual
GM700 Pro 2
Rx Only
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 2369 2388
Fax: +886 4 2261 7586
Email: info@bionime.com
http://www.bionime.com
Made in Taiwan
USA Customer Service Center:
Ontario, CA 91761, USA
Tel: +1 888 481 8485
Fax: +1 909 781-6970
http://www.bionimeusa.com
Service hour: Mon. to Fri.
8:00 AM to 5:00 PM PST.
For EMERGENCY, please contact the
healthcare professional.
Blood Glucose Monitoring System

Questions and Answers

Summary

Preface

Welcome and Usage Instructions

Expresses gratitude for choosing the product and advises careful reading of the manual.

CLIA Complexity

CLIA Waiver Status

Details the test's status under Clinical Laboratory Improvements Amendments (CLIA).

Indication for Use

System Intended Use

Describes the system's purpose for point-of-care, in-vitro diagnosis for multiple patients.

RIGHTEST Blood Glucose Meter

Meter Components Overview

Identifies key parts of the meter like the display, buttons, and barcode scanner.

RIGHTEST Charging Hub

Charging Hub Connectivity

Details the LAN and power ports on the charging hub for data transfer and charging.

RIGHTEST Test Strips

Test Strip Features and Handling

Explains the sample port, handle, indication symbol, and viewing window.

Temperature Effects on Strips

Advises on waiting periods after temperature changes before using meter or strips.

Auto-Code Holder Functionality

Sample Size and Limitations

Covers sample volume recommendations, interfering substances, and product limitations.

Product Safety Information

General Safety, Battery, and Charging Hub

Outlines safety for device operation, battery care, and charging hub usage.

Touch Screen, Scanning, and Static Protection

Details safe use of touch screen, barcode scanner, and static discharge prevention.

Network Security and Biohazard Disposal

Covers secure network use and proper disposal of biohazardous waste.

Installation Procedures

System Initialization and Connection

Guides on installing the meter, charging hub, and system connection.

Battery Recharging and Status

Explains how to charge the battery and interpret charging status indicators.

General Operation

Powering, Saving Power, and User Login

Covers turning the device on/off, power saving modes, and user login procedures.

Device Settings and Bluetooth

Details adjusting device settings like volume/brightness and Bluetooth connectivity.

Blood Glucose Measurement

Patient Identification

Describes methods for searching and identifying patients before testing.

Test Strip Information Entry

Explains how to input test strip data via scanning or manual entry.

Test Strip Detection and Sample Application

Details the process of waiting for strip detection and applying blood samples.

Fingertip Blood Sample Collection

Provides steps for collecting fingertip blood samples, including cleaning and puncturing.

Alternative Site Sample Collection

Details sample collection from palm or forearm, including preparation steps.

Lancing Device Preparation

Guides on assembling and setting the depth for the lancing device.

Important Site Testing Information

Highlights considerations for fingertip vs. palm/forearm results and rapid glucose changes.

Test Result Checking

Explains how to view test results, patient information, and interpret conditions.

Safety Warnings for Testing

Covers warnings about strip usage, temperature, and biohazard waste disposal.

Test Notes and Patient History

Covers adding notes to results and viewing patient profiles and readings.

Quality Control

QC Frequency and Lock Function

Defines when to perform QC and the function of the QC lock mechanism.

Control Solution Information

Describes selecting control solution concentration and entering required information.

Performing Control Solution Tests

Details the steps for conducting control solution tests and preparing samples.

QC Result Interpretation

Explains how to check QC results, interpret Pass/Fail messages, and handle failures.

Advanced Quality Control

Linear QC and Analysis

Describes the process for performing linear quality control and analysis.

External Quality Control

Explains how to perform external quality control tests using third-party solutions.

Maintenance and Care

Meter Maintenance Guidelines

Provides rules for keeping the meter clean and functional, avoiding damage.

Safety Precautions and References

Covers user precautions for handling the device and lists relevant external references.

Cleaning and Disinfection

Details the procedures for cleaning and disinfecting the device and test strip port.

Contact Point Cleaning

Covers cleaning the device and charging hub metal contact points.

Error Messages and Troubleshooting

Troubleshooting Common Errors

Lists common error codes and their corresponding troubleshooting steps.

Operational and Temperature Limits

Highlights temperature limitations and provides other error message advice.

Device Specifications

Technical Specifications Summary

Lists key technical details of the meter and system components.

Customer Service and Warranty

Support Contact and Warranty Terms

Provides customer service contact information and details warranty coverage.

Symbols Guide

Understanding Document Symbols

Explains the meaning of various symbols used throughout the manual.

CLIA Waiver Study Results

Accuracy Data Tables

Presents results from accuracy studies comparing the device to a laboratory comparator.

FCC Compliance Statement

FCC Regulations and RF Exposure

Details compliance with FCC rules, interference, and RF exposure guidelines.

Rightest GM700 Pro 2 Specifications

General IconGeneral
Blood SampleCapillary whole blood
Sample Size0.75 µL
Measuring Time5 seconds
Operating Temperature10 - 40 °C (50 - 104 °F)
Operating Humidity10-90% RH
Hematocrit Range30-55%
Measuring Range10-600 mg/dL
Memory500 test results
Battery2 x AAA batteries

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