Sejoy BG-710b Manuel utilisateur

Owner’s Booklet

BG-710b Blood Glucose Monitoring System

Advanced Diabetes Management System

Contents

Important Safety information ······································

Important Health-Related information ···························

Meter (battery included) ···········································

Test Strips ···························································

Lancing Device ······················································

Lancet ·······························································

Control Solution ·····················································

Setting the date and time ··········································

Setting the measuring unit ········································

Setting the test reminder ·········································

Computer connection ···········································

Preparing the lancing device ······································

Blood sampling ······················································

Testing ·······························································

Interpreting unexpected test results ·····························

When to perform a control test ···································

Performing a control test ·········································

Understanding out-of-range control test results ···············

Maintenance ·························································

Replacing the battery ··············································

Introduction ··························································

Getting to know your system ··································

Setting up your meter···············································

Testing your blood glucose ·····································

Memory and averages ···········································

Control solution testing ··········································

Comparing Your Meter Result to a Laboratory Result ········

Limitations ····························································05

Troubleshooting ························································

Technical information ·················································

Specifications ··························································

Disposing of the meter, test strips, lancets and batteries ·····

Warranty ·································································

Symbol Index ····························································

Traceability ·······························································

Performance Characteristics ········································

FCC Information ························································

Caring for your system ················································· 36

Introduction

Thank you for choosing Sejoy BG-710b blood glucose monitoring

system. Before you start testing, carefully read this .Owner’s Booklet

Intended Use

Test Principle

Peel off the insulation film from battery compartment before first use.

The strip measures glucose by using amperometric technology

employing a glucose dehydrogenase reaction.When whole blood or

control solution is drawn into the tip of a test strip,glucose in the

sample reacts with chemicals and produces an electrical current. The

meter measures electrical current and calculates amount of glucose.

The glucose result is displayed as a calculated plasma value.

The Sejoy BS-602 Test Strips are used with the Sejoy BG-

Glucose Meters to quantitative measuring blood glucose with fresh

capillary whole blood from the finger or venous blood.The system is

intended for use outside the body (in vitro diagnostic use) by people

with diabetes at home and by health care professional in a clinical

setting as an aid to monitor theeffectiveness of diabetes control.

It should not be used for the diagnosis.

710b Blood

• Venous whole samples collection and preparation should be obtained

by healthcare professionals.

Introduction

Important Safety information

Warning

• During normal testing, any blood glucose meter or lancing device may

come in contact with blood. All parts of the kit are considered

biohazardous and can potentially transmit infectious diseases from

blood borne pathogens, even after you have performed cleaning and

disinfecting.

• The meter and lancing device should never be used by more than one

person. Do not share the meter and lancing device with anyone, including

family members, due to the risk of infection from blood borne pathogens.

• Cleaning and disinfecting the meter and lancing device destroys most,

but not necessarily all, blood borne pathogens.

• If the meter is being operated by a second person who is providing testing

assistance to the user, the meter and lancing device should be cleaned

and disinfected prior to use by the second person.

• Disinfect the meter and lancing device before allowing anyone else to

handle them. Do not allow anyone else to test with the meter or lancing

device.

• It is important to keep the meter and lancing device clean and disinfected.

Clean and disinfect the lancing device once per week to remove visible dirt or

other material for safe handling and/or prior to disinfecting.

For instructions on how to clean and disinfect the meter and lancing device,

see Chapter Maintenance.

• Wash hands thoroughly before and after handling the meter, lancing device,

or test strips.

• Choking hazard. Small parts. Keep away from children.

• Strong electromagnetic fields may interfere with the proper operation of the

meter. Do not use this meter close to sources of strong electromagnetic

radiation.

• To avoid electrostatic discharge, do not use the meter in a very dry

environment, especially one in which synthetic materials are present.

Introduction

Important Health-Related information

·Patients undergoing oxygen therapy may receive inaccurate results.

·Some people with diabetes do not experience symptoms of low blood

sugar (hypoglycemia). Others, such as children or people who are

unconscious or have certain disabilities, may not be able to

communicate their symptoms to caregivers. For these reasons, do

not change any treatment without first talking to your doctor

·Run a control test when you open a new box of test strips or if you think

that your test result is incorrect. Running a control test lets you know

that the meter and test strips are working properly.

·DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT

THAT DOES NOT MATCH HOW YOU FEEL OR IF YOU BELIEVE THAT

YOUR TEST RESULT COULD BE INCORRECT. If your blood sugar

result doesn’ t match how you feel and you have followed the instructions

in this manual, follow your doctor’s instructions, or call your doctor.

·Children should be taught how to use the meter and any other medical

products appropriately

·Being severely dehydrated or losing a lot of water may give you false

(low) test results. If you think you’re suffering from dehydration, call

your doctor right away.

·If you have followed all the instructions in this booklet and still have

symptoms that don’t seem to match your test results – or if you have

questions – talk to your doctor.

Introduction

·The system is designed for using with whole blood samples. Do not use

serum or plasma samples.

·BS-602 blood glucose test strip: more than 70% of the hematocrit

ratio will affect the measurement results. Please contact your doctor

to determine your hematocrit ratio.

·Some substances may cause false results with enzymatic tests.

Introduction

Limitations

Substance Concentration

The interference listed below have been tested and shown no apparent

influence on results at the normal or higher therapy levels.

Other interfering substances in ISO 15197 Annex A are not verified, it may

also affect the test results.

Substance

Acetaminophen

Bilirubin

Creatinine

Gentisic acid

Haemoglobin

Ibuprofen

L-Dopa

Methyl-DOPA

Tolbutamide

Triglycerides

Xylose

EDTA

Substance

Ascorbic acid

Cholesterol

Dopamine

Glutathione

Heparin

Icodextrin

Maltose

Salicylate

Tolazamide

Uric acid

Pralidoxime Iodide

Galactose

Concentration

1.11 mmol/L (20 mg/dL)

2.22 mmol/L (40 mg/dL)

0.56 mmol/L (10 mg/dL)

1.25 mmol/L (22.5 mg/dL)

1111.11 mol/L (20000 mg/dL)

2.78 mmol/L (50 mg/dL)

0.03 mmol/L (0.5 mg/dL)

0.22 mmol/L (4 mg/dL)

5.55 mmol/L (100 mg/dL)

83.33 mmol/L (1500 mg/dL)

2.78 mmol/L (50 mg/dL)

11.11 mmol/L (200 mg/dL)

Concentration

0.17 mmol/L (3 mg/dL)

27.78 mmol/L (500 mg/dL)

1.1 mmol/L (20 mg/dL)

2.17 mmol/L (39 mg/dL)

500 IU/dL

60.8 mmol/L (1094.4 mg/dL)

555.56 mmol/L (10000 mg/dL)

3.33 mmol/L (60 mg/dL)

0.56 mmol/L (10 mg/dL)

1.33 mmol/L (24 mg/dL)

0.83 mmol/L (15 mg/dL)

Getting to know your system

a. Meter (battery included)

b. Test Strips

c. Lancing Device

d. Sterile Lancet

e. Control Solution

INCLUDED WITH YOUR KIT

WARNING: Keep the meter and testing supplies away from young

children. Small items such as the battery cover, batteries, test strips,

lancets, protective covers on the lancets, and control solution vial

cap are choking hazards.

Manufacturer of Lancing Device and Sterile Lancet

REP

Manufacturer of Lancing Device and Sterile LancetShandong Lianfa

Medical Plastic Products Co.. Ltd.No.1

Shuangshan Sanjian Road, 250200, Zhangqiu City, Jinan, Shandong,

PEOPLE'SREPUBLIC OF CHINA

ShanghaiInternational Holding Corp. GmbH (Europe)EC| REPEiffestrasse 80,

20537 Hamburg Germany

Beijing Ruicheng Medical Suplies Co., Ltd.

No. 558 Zhangzikou, Yangsong Town, Huairou District, 10400 Bejing, China

Lotus NL B.V.

EC REPKoningin Julinaplein 10, le Verd,2595AA, The Hague, Netherlands.

CE:0123 for sterile lancet

CE:for lancing device;

CE:0123 for sterile lancet

CE:for lancing device;

REP

Getting to know your system

a. Meter

Strip Port

LCD

“M”Button

Battery Compartment

Battery Cover

Bluetooth

Display

Measuring Unit

Test Strip Reminder

Apply Blood Sample Reminder

Memory

Test Result

Alarm Clock Reminder

Date And Time

Average

Voice

Low Battery Reminder

Temperature is rangeout of

Hypoglycemia

alarm

High blood

ketone alarm

Ketone?Ketone?

HypoHypo

HCT Result

Eject Button

“D O W N”Button

“U P” Button

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