Clever Choice HD Owner's Manual - User Manual

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BLOOD GLUCOSE MONITORING SYSTEM

Distributed by

Simple Diagnostics

P.O.Box 128,Williston Park,NY 11596 USA

24-HOUR TOLL-FREE TELEPHONE ASSISTANCE

1-877-DIABETK 1-877-342-2385

www.SimpleDiagnostics.com

For in vitro diagnostic use only

Read instructions before use

For self-testing

Sistema de Vigilancia de la Glucosa en Sangre

Distributed por:

Simple Diagnostics

P.O.Box 128,Williston Park,N

Y 1

1596 USA

LINEA DE

ATENCION

CLIENTE LAS 24-HORAS A

L DIA

(GRATUI

TO)

1-877-DIABETK 1-877-342-2385

www.SimpleDiagnostics.com

Para uso diagnostico in-vitro

Lea las instrucciones antes de utilizar

Para autoanalisis

Manual

del Usuario

BEFORE YOU BEGIN……………………………………………5
ABOUT YOUR SYSTEM…………………………………………6
INTRODUCTION TO THE SYSTEM……………………..6
ABOUT ALTERNATIVE SITE TESTING (AST)………………..7
CONTENTS OF THE KITS………………………………………9
SETTING THE METER AND DELETING THE MEMORY......13
1. Setting the date and time…………………………..…..13
2. Deleting the Memory…………………………………..14
3. Setting the alarm……………………………………….14
THE TWO MEASURING MODES……………………………..15
TESTING WITH BLOOD SAMPLE…………………………….16
Comparing Meter and Laboratory Results……………..22
CONTROL SOLUTION TEST………………………………….23
VIEWING RESULTS ON THE METER……………………….24
Recalling the Stored Test Results………………………24
Reading the Average of Blood Glucose Results………25
CARE AND STORAGE FOR YOUR SYSTEM………………26
Cleaning and Disinfection……………………………….26
METER SPECIFICATION………………………………………28
DISPLAY MESSAGE………………………………………..….31

Do not place the device in liquid, nor put it where it could fall

into liquid.
2

The following basic safety notice should always be taken.

Use the device only for the intended use described in this

manual.
4.

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

Do not make the device come into contact with surfaces

which

are too hot to touch.

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

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

been damaged.
8.

Read all the manual, 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.

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.

BEFORE YOU BEGIN

Installing the battery

2. If replacing the batteries, please remove the used batteries.
3. Insert 2 new (AAA) batteries with correct +/- direction.
4. Close the battery cover.

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.

■ 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 and the alternative sites
including the palm, the forearm, the upper arm, the calf and the
thigh. 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 to be used by a single person and should not be
shared.

■ 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. The System should
not be used for the diagnosis of or screening for diabetes, nor for
neonatal use. Alternative site testing should be done only during
steady – state times (when glucose is not changing rapidly).

■ The “CLEVER CHOICE” Test Strips are for use with the Blood
Glucose Meter to quantitatively measure glucose in fresh
capillary whole blood samples drawn from the fingertips, palm,
forearm, upper arm, calf and thigh.

■ The CLEVER CHOICE control solutions is intended for use with
the System, to check that the glucose meter and test strips are
working properly and that you are doing the test correctly. These
solutions contain a known range of glucose, as indicated on the
strips vial bottles.

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

AST in this system can be used only during steady-state blood
glucose conditions described in the section of “About AST”.

Test principle
The test is based on the measurement of electrical current gen-
erated by the reaction of glucose with the reagent of the strip. The
meter measures the current and displays the corresponding blood
glucose level. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.

ABOUT ALTERNATIVE SITE TESTING (AST)

Important: There are limitations for doing AST.
Please consult your healthcare professional before you do AST.

What is AST ?
Alternative site testing (AST)
means that people use parts of the
body other than the fingertips to
check their blood glucose levels.
This system allows you to test on
the palm, the forearm

，

the upper

arm, the calf

，

or the thigh with the

equivalent results to fingertips
testing.

Fingertips feel pain more readily because they are full of nerve
endings (receptors). At other body sites, since nerve endings are
not so condensed, you will not feel as much pain as at the fingertip.

Food , medication , illness, stress and exercise can affect blood
glucose levels. Capillary blood at fingertip reflects these changes
faster than capillary blood at other sites. Therefore when testing
blood glucose during or immediately after meal, physical exercise,
or any other event, take a blood sample from your finger only.
You do AST

in the following instances:

●

In a pre-meal or fasting state (more than 2 hours since the
last

meal).

●

Two hours or more after taking insulin.

●

Two hours or more after exercising.

■

Alternative site testing(AST) should not be used to calibrate

continuous glucose monitoring systems (CGMs).

■

Results from alternative site testing should not be used in

insulin doses calculations.

●

You think your blood glucose is low.

●

You are unaware of hypoglycemia.

●

You are testing for hyperglycemia.

●

Your AST results do not match the way you feel.

●

Your routine glucose results are often fluctuating.

Lancing Device(optional)
Sterile Lancet(optional)

Owner’s Manual

■

A Meter

■

Carry case

■
■
■
■
■

Daily Log Book

■

Clever Choice Control solution (Optional)

●

The Lancing Device can be used for several times however

the lancet should be changed after each use.

●

Adjustable Automatic Lancing Device, sterile lancet and test

strips are not included in the standard kit.

●

There are three levels for the control solutions: low, normal

and high available, please contact the place of purchase for
more information.

●

You can toll free service hotline: 1-877-342-2385, Available

24 hours a day/7 days a week, except USA Federal Holidays
(Simple Diagnostics) to buy all of the items.

If any items are missing from your kit or opened prior to use,
please contact local customer services or place of purchase for
assistance.

MEMORY SYMBOL

Appears when you

review the memory

MEASUREMENT UNIT

Appears with the test

result in mg/mL

BLOOD DROP SYMBOL

Flashes when it is ready

to apply the blood sample

TEST RESULT AREA

Displays glucose results

TIME

DATE

TEST STRIP SYMBOL

Appears when the meter

is turned on

DAY

AVERAGE

Indicate that the displayed

test result is an average

value

8 CTL SYMBOL

Appears when doing a

control test and indicates

that the result won't be

stored in the memory.

LOW BATTERY SYMBOL

Appears when the battery

power is low

ALARM SYMBO

Appears when set the alarm

Blood Glucose Meter

STRIP PORT

Where you insert the test strip.

The meter will turn on

automatically

STRIP EJECTOR

Slide forward to eject the test strip after test

LCD DISPLAY

It guides you through the test using symbols and simple

messages

“M” Button

It is used to turn on the meter, enter the memory mode
“S” BUTTON

It is used to set up the meter

DATA PORT

Located at the side, is for cable connection.

Test Strip

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

following parts:

Absorbent Hole

Apply a drop of blood here. The blood will be

drawn in automatically.
Confirmation window

This is where you confirm if enough blood has

been applied to the absorbent hole of the strip.

Test Strip handle

Hold this part to insert the strip into the slot.

Contact bars

Insert this end of the test strip into the meter.

Push it in firmly until it will go no further.

Attention!

Test results might be wrong if the contact

Bar is not fully inserted into the test slot.

The front side of the test strip should face

up when inserting the test strip.

Frente Reverso

Press “S” then “ ” “dEL " will display with flashing “no” or “yES”.

Press “M” until “yES” flashing, Press the S button 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, when

“no” flashing, press the S button to skip this step.

You may set up any or all of the alarms (1~4). When the meter is

displaying “On” or “OFF”, press the “M” button to turn on or turn

off the first alarm.

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, “12” equals 2012).Press “M” button
until the correct year appears. Press “S”.

1.2 Setting the month

With the month flashing, press “M” until the cor-

rect 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 hour

With the hour flashing, Press “M” until the cor-

rect hour appears. Press “S”.

1.5 Setting the minute

With the minute flashing, Press “M” until the cor-

rect minute appears. Press “S”.

Press the “S” button to select “On”, then to set the hour. When

the hour is flashing, press the “M” button to add an hour. When

the correct hour is set, press the “S” button to confirm and go to

set the minutes. Press the “M” button to add one minute. When

the correct minute is set, press the S button to confirm and go

to the next alarm setting.

If you want to turn off an alarm, press the S button to find the

right alarm number and press the M button to change from “O

n”

to “OFF”.

The date, time 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.

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.

CTL testing with the control solution

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 dis-

play a flashing blood drop.

2. Press M to select General or CTL mode.

TESTING WITH BLOOD SAMPLE

To reduce the chances of infection:

●

Choose a clean, dry work surface.

●
●

Always use a new and sterile lancet. Lancets 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. Simplif-

ying or changing the test procedure may produce inaccurate

results.

Cocking

Control

Release

Button

Lancet Holder

Depth Indicator

A Clear Cap

Arrow

Adjustable Tip

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

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

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.

Screw off the cap of the lancing device.

Insert a lancet into the lancet holder and

push down firmly until it is fully in place.

Twist the protective disk until it separates

from the lancet.

Replace the lancing device cap. Turn the

cap until it is snug but not too tight.

The adjustable tip offers 5 levels of skin penetration.

Twist the adjustable tip in either direction until

the number lines up with the arrow:

1-2 for soft or thin skin,

3 for average skin,

4-5 for thick or calloused skin.

Slide the cocking control back until it clicks.

If it does not click the device may have

been cocked when the lancet was inserted.

The lancing device is now ready for use.

Set aside for later use.

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.

On the lancets and the lancing device.

Please follow the suggestions below before obtaining a drop

of blood:

●

Rub the puncture site for about 20 seconds before penetration.

● Use a clear cap while setting the lancing device for AST.

Wash and dry your hands before starting.

● Select the puncture site either at the fingertips or another

body

part (please see section “Alternative Site Testing”

(AST) on how to select the appropriate sites).

● Clean the puncture site using cotton moistened with 70%

alcohol and let it air dry.
Fingertip testing
Hold the lancing device firmly against the side

of your finger. Press the release button. You

will hear a click, indicating that the puncture

is complete.

Blood from sites other than the fingertip
A clear cap, together with the kit, makes it

easier to get a drop of blood for AST. When

you want to obtain blood from sites other

than the finger, replace the lancing device

cap with the clear cap. Turn the clear cap

until it is snug but not too tight, and then

slide the cocking control back until it clicks.

Choose a different spot each time you test. Repeated

punctures at the same spot may cause soreness and calluses.

■

Please consult your health care professional before you

begin AST.

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

might

contain tissue fluid, which may a

fect the test result.

Performing a Blood Glucose Test
Step 1.

Wash hands with soap and warm water.
Step 2.

Remove a test strip from its vial. With clean, dry hands, you may

touch the test strip anywhere on its surface. Do not bend, cut or

modify the test strips in any way. Remove the test strip from the

vial and use it instantly.
Step 3.

Insert the test strip into the meter's test port and the meter is

turned on. The time and date appears on the screen.

NOTE: Be sure to use CLEVER CHOICE test strips, other test

strips may not produce accurate results.

Step 4

When the blood drop symbol flashes on the

screen, you may select the appropriate measure-

ment mode, for selecting the measurement mode

of Control(CTL) or General, please refer to the

“THE TWO MEASURING MODES” section.

Step 5

Apply your blood to the absorbent hole of the test strip.

Step 6

As soon as enough blood has filled the confir-

mation window of the test strip, you will hear a

beep letting you know the test has begun. A

countdown of 5 seconds starts.

Note: make sure the confirmation window of the Test Strip is

completely filled with your blood sample.

Step 7

Your blood glucose level, along date and time

appears on the display. Blood glucose results

are automatically stored in the memory.

The results obtained from this meter are plasma-calibrated. This

helps you and your physician or other qualified healthcare

provider to compare your meter results with laboratory tests.

Reference to the instructions given by your physician or other

qualified healthcare provider, do not deviate from these instructions

on the basis of the result without first consulting your physician.

Step 8

Eject the used test strip and remove the lancet. To

eject the test strip, point the strip at a disposal

container for sharp objects. The meter will switch

itself off automatically after the test strip is ejected.

Please wash hands thoroughly with soap and

water after handling the meter, lancing device, or

test strips.

Reference value:
Time of day

People without diabetes

Before breakfast (fasting) <100 mg/dL
Two hours after meals <140 mg/dL
Source: American Diabetes Association. Standards of Medical

Care in Diabetes-2012.Diabetes Care 2012,35

（

Suppl.1)S11-S63.

Please work with your doctor to determine a target range that

works best for you.

The meter provides you with whole blood equivalent results. The

result you obtain from your meter may differ somewhat from your

laboratory result due to normal variation. Meter results can be

affected by factors and conditions that do not affect laboratory

results in the same way. To make an accurate comparison

between meter and laboratory results, follow the guidelines below.
Before going to the lab:

■

Do a control solution test to make sure that the meter is

working properly.

■

Fast for at least eight hours and then do comparison tests,

if possible.

■

Take your meter with you to the lab.

While staying at the lab:
Make sure that the samples for both tests test are taken and

tested within 15 minutes of each other.

■

Wash your hands and then obtain a blood sample

■

Never use your meter with blood that has been collected in

a gray top test tube.

■

Use fresh capillary blood only.

meter.The “ ” symbol will flash with the time and date dis-

played on the

CONTROL SOLUTION TEST

Material needed:

●

Glucose Meter

●

Clever Choice Test strips

●

Clever Choice Control solution

When to do a control solution test:

◆

When you open a new vial of test strips

◆

When you suspect that the meter or test strips are not

working

properly.

◆

If your blood glucose test results are not consistent with

how you feel.

◆

After the test strips are exposed to extreme conditions.

◆

After dropping the meter.

The control solution is to check that the meter and the test

strips can work together as a system and work correctly.

Step 1
Insert the test strip to turn on the meter. Insert the test strip into

the meter. Wait for the meter to display the drop symbol.
Step 2

You may press “M” button to select CTL mode, for
selecting the CTL mode, please refer to the “THE
TWO MEASURING MODES” section.
Step 3
Apply the control solution

Shake the control solution vial thoroughly before use.
Squeeze out a drop and wipe it off, then squeeze another drop

and place it on the tip of the vial cap.
Hold the meter to move the absorbent hole of test strip so it

touches the drop. Once the confirmation window fills completely,

the meter will begin counting down.

To avoid contaminating the control solution, do not directly

apply control solution onto a strip.

The result of the control solutions test appears on the display.

The result will not be stored under CTL mode.
The result of the control solutions test should be within the range
printed on the test strip vial label. If the test results falls outside
the specified range printed on test strip vial label, repeat the test.
Results falling outside the specified range may be caused by:

■

Error in performing the test

■

Expired or contaminated Control Solution

■

Expired or contaminated Test Strip

■

Malfunction of your Meter

If you continue to get control solution test results that fall outside
of the range printed on the vial, the system may not be working
properly, Do not use the meter. Please contact your customer
support immediately. 24-hour toll free service hotline:
1-877-342-2385

Your meter stores the 500 most recent blood glucose test results

with dates and times. It also provides 7-, 14-, 21-, 28-, 60- and 90

-day averages of your blood glucose test

results.

Note: The control solution readings are not included in the

average of your results.

1.Start with the meter off, press the button to turn on the

screen.

2.Press again, the most recent test results with date and time

will display. Press “M” once more and the next most recent test

results will appear. Each time you press and release “M”, the

meter will recall up to your last 500 test results in order. Press

the “S” to turn off the meter. When the memory is full, the oldest

result is dropped and the newest result is added.

Reading the Average of Blood Glucose Results
When the meter is off, press and hold the “M” button until the DAY

AVG flashing, release button then 7-day average results appear

with “n024” (means 24 records to be averaged) on the screen.

Press the “M” button to review the 14-, 21-,28-, 60- and 90-day

general averages. Press the S button to turn off the meter.
Note: The control solution readings are not included in the

average of your results.

CARE AND STORAGE FOR YOUR SYSTEM

◆

Handle the meter with care. Dropping or throwing the meter

may cause damage to the device.

◆

Don't expose the Blood Glucose Monitoring System, Test strip,

and Control Solution, to extreme conditions, such as high

humidity, heat, freezing cold or dust. The storage conditions

for the test strips are 39

86 , Humidity

＜

85%RH. Storage

conditions for the meter are -40

131 , Humidity

＜

80%RH.

◆

Always wash your hands with soap and water and rinse and

dry completely before handling the Blood Glucose Monitoring

system and Test strip.

◆

Use CaviWipes (see below) to clean the Blood Glucose Monit

oring System.

◆

Discard the used lancet into a container for sharp objects.

Cleaning and Disinfection
The cleaning and disinfection is absolutely necessary for

the test procedure, because cleaning can insure the meter

works well (for example, display will be clear to see after

cleaning); and disinfection can avoid the infection to you

or to the other people, and the cross-infection. We strongly

warn that the device should be cleaned and disinfected

following use on every patient. And we suggest you use the

following product: CaviWipes (EPA registration number

：

46781-8

）

. You can purchase this product according to the

following information: visit the web site: www.metrex.com or

contact Metrex at 800-841-1428 for product or technical

information. CaviWipes are also available at www.amazon.

com or via a Google search.

The meter for single-patient use and the lancing devices

may be cleaned 5-6 times per day (Test 5-6 times every day),

so the meter will be cleaned and disinfect about 11000 cycles

that include cleanings plus disinfections (1 cycle = 1 cleaning

+ 1 disinfection) during its 5 years life cycle.
1. Before the test, the user should clean and wash hands. If you

are a caregiver, (not the patient), the please use disposable

gloves.

2. After test, take one wipe to clean the meter’s housing, buttons,

lens, mark, usb cover and support block, including its front and

back for 10 seconds for cleaning until there is no soil on the

surface. Then disinfect the meter’s housing, buttons, lens, mark,

usb cover and support block use another wipe for 2 min, keep

the surface wet for 2 min.

3. Take off the glove; discard carefully according to your health-

care provider’s instruction.

Note:

1. Each disinfection step requires a pre-cleaning step.

2. If the meter is being operated by a second person who is pro-

viding testing assistance to the user, the meter and lancing

device shall be cleaned and disinfected first.

3. The users should wash hands thoroughly with soap and water

after handling the meter, lancing device, or test strips.

4. If you have any questions you can dial the number

1-877-342-2385

5. Please refer to the following linkage for detail information:

“FDA Public Health Notification: Use of Fingerstick Devices

on More than One Person Poses Risk for

Transmitting

Bloodborne Pathogens: Initial Communication” (2010)

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/

ucm224025.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More

than One Person Poses Risk for Transmitting Bloodborne

Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick

-DevicesBGM.html

6. Table: A list of the signs of potential deterioration

(Physical and in performance)
What do you see?

What to do?

The buttons do Stop using and contact local customer

not work

services or place of purchase for

assistance, or toll free service

hotline:

1-877-342-2385
The device does Stop using and contact local customer

not work services or place of purchase for assi-

stance, or toll free service hotline:

1-877-342-2385
Discoloration of the Stop using and contact local customer

buttons , meter services or place of purchase for assi-

casing or lancing stance, or toll free service hotline:

device 1-877-342-2385
Corrosion, crazing, Stop using and contact local customer

embrittlement, crac- services or place of purchase for assi-

king of the buttons, stance, or toll free service hotline:

meter casing, display 1-877-342-2385

or lancing device
Cloudiness of the Stop using and contact local customer

lens services or place of purchase for assi-

stance, or toll free service hotline:

1-877-342-2385

1. Model: CLEVER CHOICE HD (with “Clever Choice” test strip

and Clever Choice control solution)

2. Machine size: 88mm (L)×55mm (W)×26mm(H)

3. Weight: 45g (excluding batteries)

4. Measuring method: Amperometric technology using glucose

oxidase

5. Result range: 20 mg/dL ~600 mg/dL(1.1 mmol/L ~33.3mmol/L)

6. Glucose Units: Either mg/dL or mmol/L (USA version preset

mg/dL only)

7. Memory : 500 blood glucose tests

8. Display: LCD display with backlight

9. Power source: DC 3V (AAA×2 alkaline batteries)

10. Battery Life: Approx. 500 normal tests

11. Storage Condition: Blood glucose Monitoring system (meter

and test strips): 39

86 , Humidity

＜

80%RH.

12. Storage Condition (meter): -40

131 , Humidity

＜

80%RH

13. Operating conditions: 50

104 , Humidity:25%~80%RH

14. Blood Source: Fresh capillary whole blood

15. Blood Volume: Minimum 0.7 micro liter.

16. Use life: five years
NOTE: Factors affecting the life of the meter

The factor
The aging

of the strip

connector

The clou-

ding of the

lens

The aging

of the el-

ectronic

components

The indication

The meter cannot be

turned on when In-

serting the test strip

several times.

The content displayed

on the lens cannot be

recognized clearly.

The results are not

accurate when the

test strips are in

normal mode.

Do this:
please contact local cus-

tomer services or place

of purchase for assistance,

or toll free service hotline:

1-877-342-2385
please contact local cus-

tomer services or place

of purchase for assistance,

or toll free service hotline:

1-877-342-2385
please contact local cus-

tomer services or place of

purchase for assistance,

or toll free service hotline:

1-877-342-2385

※

The blood Monitoring System is not intended for use on neo-

nates.

※

The blood Monitoring System is not intended for use on

artery blood, neonates’ serum and plasma.

※

The Blood Glucose Meter should be used with “CLEVER

CHOICE” test strip.

※

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, 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 hae-

molysis sample, icterus sample or high lipemia samples.

※

The following compounds, when determined to in excess of

their limitation, may produce inaccurate results:

Compound
Ascorbic acid

Uric acid
Acetaminophen
Bilirubin
Dopamine

L-dopa
Methyldopa

Tolbutamide
Triglycerides

Hemoglobin

Limitation

＞

2mg/dL

＞

10mg/dL

＞

5mg/dL

＞

15mg/dL

＞

0.03mg/dL

＞

0.45mg/dL

＞

0.75mg/dL

＞

24mg/dL

＞

2000mg/dL

＞

250mg/dL

※

Patients undergoing oxygen therapy may yield falsely lower

results.

※

Not for use 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 hemarocrit level, please consult your

health care provider.

MESSAGE

WHAT IT MEANS
Blood glucose level is

lower than 20mg/dl

(1.1mmol/L)

Blood glucose level is

higher than 600 mg/dl

(33.3mmol/L)

Meter is ready to test

control solution under

the CTL state.

Battery power is low.

ACTION

The message indicates

very low blood sugar. You

should consult with your

healthcare professional.

This indicates sever

hyperglycemia (high

blood glucose).
You should seek imme-

diate medical assistance.
Please place a drop of

control solution onto the

test well of test strip.

Please change the

battery.

MESSAGE

WH AT IT MEANS

Use a used test strip.

Error massage indicates

that you may remove the

strip after applying blood

to the absorbent hole.
Problem with the meter.

Environmental tem-

perature is lower than

10 (50 ) or higher

than 40 (104 )

ACTION

Please use a new strip

and re-test.

Try again with a new

test strip.

Re-test with a new test

strip. If the problem is

still unsolved, please

call the Customer Care

Line for help.

Please test at an envi-

ronmental temperature

Display remains

blank after the

test strip has

been inserted

into the Meter.

1. Battery may be

installed improperly.

2. Battery power is

too low for use.

3. Too much time has

passed between

inserting the Test

Strip and perfor-

ming the test.

1.Install the Battery

correctly.

2.Replace with new

Battery.

3.Reinsert the Test

Strip into the

Meter.

4. Test Strip has not

been fully inserted

into the Meter.

4. Reinsert the Test

Strip into the Meter.

Test results

are incon

sistent or

Control

Solution test

results are

not within

the specified

range.

1. Not enough sample

in the Test Strip.

2. Test Strip or Control

Solution has expired.

3. Test Strip has been

damaged due to

heat or humidity so

that sample cannot

be applied or the

speed of applying

sample is too slow.

4. System is not per-

forming due to the

environment being

above or below

room temperature.

1. Redo test with new

test strip and make

sure that enough

sample has been

added.

2. Redo test with new

test strip.

3. Perform a Control

Solution test using a

new Test Strip. If

results are still out of

range, replace with

new vial of Test Strips.

4. Bring System to a

room temperature

environment and

wait approximately 30

minutes before per-

forming a new test.

The Meter co-

untdown did

not start.

Test Strip has not

been inserted

correctly.

Use a new Test Strip

and redo the test.

611-42500A-001

VER 1.1

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