Glucoracy G-425-2 User manual

User Manual

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Read this before using

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

DANGER - Misuse of this electrical device can cause

electrocution, burns, fire and other HAZARDS.

Basic safety precautions should always be taken, including

all those listed below.

Close supervision is necessary when equipment is used

by, on, or near children, handicapped persons or invalids.

The following basic safety notices should always

be taken:

1. Do not place the device in liquid, nor put it where it

could fall into liquid.

2. The following basic safety notices should always be taken.

3. Use the device only for the intended use described in

this manual.

4. Do not use adjunct which are not supplied by the producer.

5. Do not make the device come into contact with surfaces

which are too hot to touch.

6. Do not use the device where aerosol sprays are being

used.

7. Do not use the device if it is not working properly, or if

it has been damaged.

8. Read all the manuals, and practice the test, and then use

the product to test your blood glucose. Do all quality control

checks as directed and consult with a diabetes expert.

Dear Glucoracy Blood Glucose Monitoring System

G-425-2 Owner:

Thank you for choosing this system!

This manual contains important information you must

know about the system.

Please read it thoroughly and carefully.

The system provides No Code function which means that

you don't need to calibrate your meter making it easier for

the user to monitor blood glucose at home.

Important safety instructions

The meter and lancing device are for single patient use.

Do not share them with anyone including other family

member! Do not use on multiple patients!

All parts of the kit are considered biohazardous and can

potentially transmit infectious diseases even after you

have performed cleaning and disinfection.

Changes or modifications not expressly approved by

the party responsible for compliance could void the

user’s authority to operate the equipment.

Installing the battery

1. Open the battery cover on the back of meter.

2. If replacing the batteries, please remove the used batteries.

3. Insert 2 new (AAA) batteries with correct +/- direction.

4. Close the battery cover.

►The Blood Glucose Monitoring System is not intended

for use on neonates.

►The Blood Glucose Monitoring System is not intended

for use on artery blood, neonates’ serum and plasma.

►The system can be used up to an altitude of 10744 feet.

►The following substances at levels greater than normal

or therapeutic levels may cause significant interference

(affect the result by greater than 10%) resulting in an

inaccurate result: ascorbic acid, uric acid, hemoglobin，

acetaminophen, Dopamine, L-dopa and Tolbutamide

etc. These sub- stances do not affect test results in

normal concentration but may affect test results in high

concentration. Do not use haemolysis sample, icterus

sample or high lipemia samples.

►Patients undergoing oxygen therapy may yield falsely

lower results.

►Not used for patients in a hyperglycemic-hyperosmolar

state, with or without ketosis.

►Not for use on critically ill patients.

►Not to be used for patients who are dehydrated,

hypertensive, hypotensive or in shock.

►Very low (less than 20%) or very high (more than 60%)

red blood cell count (hematocrit) can lead to incorrect

test results. If you do not know your hematocrit level,

please consult your health care provider.

►High temperature (more than 104°F) and low temperature

(less than 50°F) may lead to incorrect test results.

►High humidity (more than 85%) and low humidity (less

than 10%) may lead to incorrect test results.

Environment Protection – Waste electrical products should

not be disposed of with household waste. Please recycle

where facilities exist. Check with your local Authority or

retailer for recycling advice.

Limitations of use: Before Your Begin

■ The System is intended for use outside the body (in vitro

diagnostic use). It is for single-patient use. It should be used

only for testing glucose (sugar) and only with fresh capillary

whole blood samples taken from the finger. The system is

intended for use at home. It should not be used for the

diagnosis of diabetes or for the testing of newborns.

■ The System is intended for self-testing outside the body

(in vitro diagnostic use) by people with diabetes at home

as an aid to monitor the effectiveness of diabetes control.

Alternative site testing should be done only during steady

– state times (when glucose is not changing rapidly).

■ The blood glucose test strips are for use with the Blood

Glucose Meter to quantitatively measure glucose in fresh

capillary whole blood samples drawn from the fingertips.

■ This device is not intended for use in healthcare or assisted-use

settings such as hospitals, physician’s offices, or long-term

care facilities because it has not been determined to be safe

and effective for use in these settings, including for routine

assisted testing or as part of glycemic control procedures.

■ Use of this device on multiple patients may lead to transmission

of Human Immunodeficiency Virus (HIV), Hepatitis C Virus

(HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

■ When the following phenomenon happens, the user should

stop using meter and contact customer service:

-The test result of control solution exceeds the range of vial labeled.

-The meter fails to display relative information;

-The meter does not respond when inserted test strips;

-The meter damaged severely (eg. Broken case, screen chalkboard)

Warnings

Intended Use

INTRODUCTION TO THE SYSTEM

ABOUT YOUR SYSTEM

■

The Glucoracy Blood Glucose Monitoring System is

comprised of Glucoracy Blood Glucose Meter and

Glucoracy Blood Glucose Test Strips.

■

The Glucoracy Blood Glucose Monitoring System is intended

to be used for the quantitative measurement of glucose

(sugar) in fresh capillary whole blood samples drawn from

the fingertip. The Glucoracy Blood Glucose Monitoring

System is intended to be used by a single person and

should not be shared. It is intended for self-testing outside

the body (in vitro diagnostic use) by people with diabetes

at home as an aid to monitor the effectiveness of diabetes

control. The Glucoracy Blood Glucose Monitoring System

should not be used for the diagnosis of or screening for

diabetes. The Glucoracy Blood Glucose Monitoring System

is not for use in neonates.

Overview of the lancing device

A.Device Cap

B.Handle

C.Needle Cap

D.Needle Holder

E.Device Body

F.Connecting Collar

G.Adjustable Tip

H.Release Button

I .Ejection Button

J .Device Control Cap on the

Lancets and the Lancing Device.

If your lancing device differs from the one shown here, please

refer to the manufacturer’s manual to ensure proper usage.

NOTE:

To reduce the chance of infection:

●

Never share a lancet or the lancing device.

●

Always use a new, sterile lancet. Lancets are for single use only.

●

Avoid getting hand lotion, oils, dirt, or debris when handling the

lancets.

1. Screw the device cap off. 2. Put the needle into the needle

holder until it reaches the bottom.

3. Screw the needle cap and

put it in the recycling dustbin.

4. Cover the cap 5. Adjust the proper level

(usually level 3)

6. Aiming at the sterilized part

for blood-taking, press the

blue release key to finish

blood taking.

7. Screw the device cap. 8. Push the ejection button and

discard the used lancet in

appropriate container.

9. Cover the device cap.

NOTE:

The adjustable tip offers 5 levels of skin penetration. Twist the

adjustable tip to the proper level:

1-2 level for soft or thin skin

3 level for average skin

4-5 level for thick or calloused skin

Setting up the lancing device

NOTE:

■

The date, time, unit and memory deletion can ONLY be set in

the setting mode.

■

When the meter is in setting mode, if no button is pressed within

3 minutes, the meter will turn off.

■

No set up necessary, meter is pre-set. Meter is pre-set for Eastern

Standard Time. Please refer to page 13 of this manual for set

up instruction.

Setting the meter and deleting the memory

1. Setting the date and time

1.1 Setting the year

Press and Hold “S” button for 3 seconds, until

the last two digits of the year will flash on the

screen (for example, “14” equals 2014). Press

“M” button until the correct year appears.

Press “S”.

1.2 Setting the month

With the month flashing, press “M” until the

correct month appears. Press “S”.

1.3 Setting the day

With the day flashing, Press “M” until the

correct day appears. Press “S”.

1.4 Setting the AM/PM

With the AM or PM flashing, Press “M” until

the correct one appears. Press “S”.

1.5 Setting the hour

With the hour flashing, Press “M” until the

correct hour appears. Press S“.

1.6 Setting the minute

With the minute flashing, Press “M” until the

correct minute appears. Press “S”.

2. Deleting the Memory

2.1 Press “S” , then “dEL” will display

with flashing “M”.

2.2 Press “M” once to confirm delete,

press “M” button again to delete

ALL memory. The meter then

displays “OK”, which means that

the memory is deleted. If you don’t

want to delete the memory, press

the S button to skip this step. The

meter will automatically turn “OFF”,

and the set up will be completed.

Meter Screen Display Message Test Strip

1) Blood drop symbol

Flashes when it is ready to apply the blood sample.

2) Low battery symbol

Appears when the battery power is low.

3) Test strip symbol

Appears when the meter is turned on.

4) Test result area

Displays glucose results

5) Measurement unit

Appears with the test result in mg/dL

6) CTL symbol

Appears when doing a control test and indicates that the result

won’t be stored in the memory

7) Memory symbol

Appears when you review the memory

8) Date

9) Time

Each strip can be used only once. The test strip consists of the

following parts:

Attention!

Test results might be wrong if the contact

bar is not fully inserted into the test slot.

NOTE: The front side of the test strip should

face up when inserting the test strip.

1-Absorbent hole

Apply a drop of blood here. The blood will

be drawn in automatically.

2-Confirmation window

This is where you confirm if enough blood has

been drawn into the absorbent hole of the strip.

3-Test strip handle

Hold this part to insert the test strip into the

slot.

4-Contact bars

Insert this end of the test strip into the meter.

Push it in firmly until it will go no further.

Test principle

The System uses electrochemical methodologies. The System

quantitatively measures blood glucose levels using an Amperometric

method. The method involves detecting the current produced from

glucose oxidation. The strength of the current produced by the

reaction depends on the amount of glucose in the blood sample.

The electrons generated during this reaction are transferred from

the blood to the electrodes. The magnitude of the resultant current

is proportional to the concentration of glucose in the specimen.

The current level is converted into a readout displayed on the meter.

Contents of the kits

NOTE:

■

A Meter

■

Owner’s Manual

■

Test Strips

■

Lancing Device

■

Sterile Lancet

Blood Glucose Meter

1. Strip port

Where you insert the test strip into strip port, the meter will

turn on automatically.

2. Strip ejector

Slide forward to eject the test strip after test.

3. LCD Display

It guides you through the test using symbols and simple

messages

4. "M" Button

It is used to turn on the meter to enter the memory mode

5. "S" Button

It is used to set up the meter

■ The Lancing Device can be used for several times, however

the sterile lancet should be changed after each use.

■ Control solution is not included in the standard kit.

■ There are three levels for the control solutions: level 1,

level 2 and level 3 available, please contact the place of

purchase for more information.

If any items are missing from your kit or opened prior to use,

please contact local customer services or place of purchase

for assistance.

NOTE：

●

Choose a different spot each time you test. Repeated punctures

at the same spot may cause soreness and calluses.

●

It is recommended to discard the first drop of blood as it might

contain tissue fluid, which may affect the test result.

Fingertip testing

Hold the lancing device firmly against the

side of your finger. Press the release key.

You will hear a click, indicating that the

puncture is complete.

Preparing the puncture site

Stimulating blood perfusion by rubbing the puncture site prior to

blood extraction has a significant influence on the glucose value

obtained. Blood from a site that has not been rubbed exhibits a

measurably different glucose concentration than blood from the

finger. When the puncture site was rubbed prior to blood extraction,

the difference was significantly reduced.

Please follow the suggestions below before obtaining a drop of blood:

●

Rub the puncture site for about 20 seconds before penetration.

●

Select the puncture site at the fingertips.

●

Clean the puncture site using cotton moistened with 70% alcohol

and let it air dry.

Modes Use when

General test (not display)

CTL

Any time of day without regard

to time since last meal

Testing with the control solution

Testing with blood sample

CAUTION:

To reduce the chances of infection:

●

Choose a clean, dry work surface.

●

Never share a lancing device and lancet with another person.

●

Always use a new and sterile lancet. Lancets are for single use only.

●

Always use a new test strip. Test strips are for single use only.

●

Avoid getting lotion, oils, dirt or debris in or on the lancet and

lancing device.

Note: Before testing, please read the following steps thoroughly

and carefully, please relax and do the test step by step.

Simplifying or changing the test procedure may produce

inaccurate results.

The two measuring modes

The meter provides you with two modes for measuring, General

and CTL. The CTL mode should be used when a control solution

is being tested. See the table below.

You can switch between each mode by:

1. Start with the meter turned off. Insert a test strip to turn on the

meter, the screen will display a flashing blood drop, time and date.

2. Press “S” to select General or CTL mode.

G-425-2 Blood Glucose Monitoring System