Sejoy BG-202 Manuel utilisateur

Owner’s Booklet

BG-202 Blood Glucose Monitoring System

Advanced Diabetes Management System

BG-202

Contents

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

Meter ··············································································································

Test Strip ··········································································································

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

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

Included in your kit ························································································

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

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

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

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 ···························································································

Meter maintenance ··························································································

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·············································

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

Limitations ····································································································

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

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

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

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

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

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

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

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

Appendix ·································································································································

Introduction

Thank you for choosing Sejoy BG-202 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 oxidase 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.

• • Venous whole samples collection and preparation should be obtained

•

••

by healthcare professionals.

The Sejoy BS-102 Test Strips are used with the Sejoy BG-202 Blood Glucose

Meter to quantitative measure blood glucose with fresh capillary whole blood

or venous whole blood. The system is intended for in vitro diagnostic home-use

and by healthcare professional in a clinical setting as an aid to monitor the

effectiveness of diabetes control. This system is not for use in the diagnosis of

diabetes mellitus, screening nor for testing newborns.

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

disinfection.

• 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

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 included. 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 glucose

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 fresh capillary whole blood, Do not use

arterial blood, serum or plasma.

·Do Not test on neonatal sample(new born).

·Inaccurate test results may be obtained at high altitude more than about 3048

meters above sea level.

·BS-102 blood glucose test strip: less than 30% or more than 55% 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

The interference listed below have been tested and shown no apparent

influence on results at the normal or higher therapy levels.

Acetaminophen

Ascorbic acid

Ibuprofen

2.0 mg/dL

4.2 mg/dL

Levodopa

Creatinine

Dopamine

No clear range of effective drug concentration

1.5 mg/dL

0.04 mg/dL

Tetracycline

0.5 mg/dL

Urate

8.0 mg/dL

Other interfering substances in EN ISO 15197 : 2015 Annex A are not

verified, it may also affect the test results.

Getting to know your system

a. Meter (battery included)

b. Test Strips

c. Lancing Device

d. Sterile Lancet

e. Control Solution

f. Carrying case

INCLUDED IN YOUR KIT

WARNING: Keep the meter and testing supplies away from

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

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

cap are choking hazards.

In-door glucose measurement is recommended.

Manufacturer of Lancing Device and Sterile Lancet

EC REP

Manufacturer of Lancing Device and Sterile L an cetShandong Lianfa

Medical Plastic Products Co.. Ltd.No.1

Shuangshan Sanjian Road, 250200, Zha ng qiu City, Jinan, Shandong,

PEOPLE'SREPUBLIC OF CHINA

ShanghaiInternational Holding Corp . Gm bH ( Eu rope)EC| REPEiffestrasse 80,

20537 Hamburg Germany

Beijing Ruicheng Medical Suplies C o. , Lt d.

No. 558 Zhangzikou, Yangsong Tow n, H uairou District, 10400 Bejing, China

Lotus NL B.V.

EC REPKoningin Julinaplein 10, le Verd, 25 95AA, The Hague, Netherlands.

CE:0123 for sterile lancet

CE:for lancing device;

CE:0197 for sterile lancet

CE:for lancing device;

EC REP

Battery Compartment

Battery Cover

BG-202 BLOOD

GLUC OSE METE R

For tes ting gl ucose in whole blood wi th the

Sejoy BS -102 Blood G lucos e Test Stri ps

BG-20210060 20000000

0197

CR 203 2 (DC 3V)

Hangzhou Sejoy Electronics &

Instruments Co.,Ltd.

ECREP

Shanghai International

Holding Corp.GmbH (Europe)

MADE I N CHINA

For In vitro D iagno stic Use only

The mete r is intended t o be used for t he quan titative

measu rement of gluc ose in ca pilla ry whole bloo d

℃

For tes ting gl ucose in whole blood wi th the

Sejoy BS -102 Blood G lucos e Test Stri ps

0197

CR 203 2 (DC 3V)

Hangzhou Sejoy Electronics &

Instruments Co.,Ltd.

ECREP

Shanghai International

Holding Corp.GmbH (Europe)

MADE I N CHINA

For In vitro D iagno stic Use only

The mete r is intended t o be used for t he quan titative

measu rement of gluc ose in ca pilla ry whole bloo d

℃

AVG

mg/dL mmol/L

MEM

Getting to know your system

a. Meter

Display

Measuring Unit

Test Strip Reminder

Apply Blood Sample Reminder

Memory

Temperature is out of range

Low Battery Reminder

Test Result

Month

Date

Alarm Clock Reminder

Time

Average

mmol/L

BG-202

Strip Port

LCD

“M”Button

“S” Button

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