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SD CodeFree User Manual

SD CodeFree
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L21CF1ENR2
Issue date : 2012.08
C-4th&5th Floor Digital Empire Building 980-3,
Yeongtong-dong, Yeongtong-gu, Suwon-si, Kyonggi-do, Korea
01GM11/01GC11 series
TEL : +82-31-300-0400 FAX : +82-31-300-0499
For further information on
please contact your
SD BIOSENSOR, Inc.
Representative
User Instruction
Guide
BLOOD GLUCOSE MONITORING SYSTEM
No
Coding
www.sdbiosensor.com
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SD CodeFree Specifications

General IconGeneral
Test Time5 seconds
CodingNo coding required
Operating Temperature10-40°C (50-104°F)
Operating Humidity10-90% RH
Blood SampleCapillary whole blood
Battery LifeApproximately 1, 000 tests
Measurement Range20 - 600 mg/dL (1.1 - 33.3 mmol/L)
Memory500 test results

Summary

Chapter 1: Understanding Your New System

Before You Start Testing

Crucial preliminary steps and safety information before commencing blood glucose testing.

Special Information for Healthcare Providers and Caregivers

Specific guidance tailored for medical professionals and individuals providing care.

Indication for Use (Purpose of the Device)

Clearly defines the intended purpose and application of the blood glucose monitoring system.

Product Description and Principle of Use

Details the meter's features and the underlying scientific principle of operation.

Complete SD CodeFree™ Blood Glucose Monitoring System

Lists all the items included as part of the complete SD CodeFree™ monitoring system.

The SD CodeFree™ Meter Overview

Identifies and explains the various parts and display features of the meter.

The SD CodeFree™ Test Strip

Explains the proper handling and application of the SD CodeFree™ test strip.

SD CodeFree™ Accessories

Details the available accessories designed to complement the SD CodeFree™ system.

Changing the Meter Battery

Provides step-by-step instructions for safely replacing the meter's battery.

Meter Setup and Configuration

Guides users through initial meter setup, including alarms, date, and time settings.

Proper Test Strip Usage Guidelines

Outlines essential information and precautions for using SD CodeFree™ test strips correctly.

Chapter 2: Control Solution Test

Performing a Control Solution Test

Step-by-step instructions for executing a control solution test to ensure system accuracy.

Troubleshooting Control Solution Tests

Addresses common issues encountered during control solution tests and offers solutions.

Chapter 3: Testing Your Blood Glucose

Obtaining a Blood Sample

Detailed guide on preparing the lancing device and collecting a blood sample.

Performing a Blood Glucose Test

Comprehensive instructions for conducting a blood glucose test with the meter.

Alternative Site Testing (AST) Procedures

Explains how to perform blood glucose tests using sites other than the fingertip.

Interpreting Blood Glucose Results

Guidance on understanding and interpreting the blood glucose readings displayed by the meter.

Chapter 4: Using the Meter Memory

Searching Stored Test Results

Instructions for reviewing past blood glucose readings stored in the meter's memory.

Downloading Results to a Computer

Information on transferring test data from the meter to a computer via software.

Chapter 5: Maintenance and Troubleshooting

Performing the Check Strip Test

Procedure for using a check strip to confirm the meter's operational status.

Cleaning the Blood Glucose Meter

Recommended methods for cleaning the meter to maintain its optimal performance.

Meter Maintenance, Testing, and Transportation

Guidelines for proper care, testing, and safe transport of the monitoring system.

Cleaning the Lancing Device

Instructions for cleaning and disinfecting the lancing device to ensure hygiene.

Screen Messages and Troubleshooting

Explains common screen messages and provides troubleshooting steps for error conditions.

Warnings, Precautions, and Limitations

Essential safety warnings, precautions, and limitations associated with system use.

Chapter 6: Product Technical Information

System Specifications

Detailed technical specifications of the SD CodeFree™ blood glucose monitoring system.

Electromagnetic Compatibility

Information on the meter's compliance with electromagnetic compatibility standards.

Annex 1: Information for Healthcare Professionals

Annex 2: Symbols and Labels

Meter Label Symbols

Explains the meaning of symbols found on the meter's labeling.

Package Symbols for the BGM System

Describes the various symbols used on the packaging of the BGM system.

Test Strip Container Symbols

Details the symbols present on the test strip container label.

Annex 3: References

Annex 4: Supplies and Accessories