Clever Choice HD Owner`s manual

Clever Choice HD Owner`s manual
Distributed by
Simple Diagnostics
P.O.Box 128,Williston Park,NY 11596 USA
For in vitro diagnostic use only
Read instructions before use
For self-testing
Sistema de Vigilancia de la Glucosa en Sangre
del U
Distributed por:
Simple Diagnostics
P.O.Box 128,Williston Park,NY 11596 USA
Para uso diagnostico in-vitro
Lea las instrucciones antes de utilizar
Para autoanalisis
DANGER - Misuse of this electrical device can cause
electrocution, burns, fire and other HAZARDS.
BEFORE YOU BEGIN……………………………………………5
Basic safety precautions should always be taken, including
all those listed below.
ABOUT YOUR SYSTEM…………………………………………6
Close supervision is necessary when equipment is used by,
on, or near children, handicapped persons or invalids.
CONTENTS OF THE KITS………………………………………9
1. Do not place the device in liquid, nor put it where it could fall
into liquid.
1. Setting the date and time…………………………..…..13
2. The following basic safety notice should always be taken.
2. Deleting the Memory…………………………………..14
3. Use the device only for the intended use described in this
3. Setting the alarm……………………………………….14
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 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.
Comparing Meter and Laboratory Results……………..22
Recalling the Stored Test Results………………………24
Reading the Average of Blood Glucose Results………25
Cleaning and Disinfection……………………………….26
METER SPECIFICATION………………………………………28
DISPLAY MESSAGE………………………………………..….31
Installing the battery
■ 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.
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.
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 to be used by a single person and should not be
■ 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.
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 generated 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.
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
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.
A Meter
Carry case
Owner’s Manual
Daily Log Book
Lancing Device(optional)
Sterile Lancet(optional)
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.
Appears when you
review the memory
Appears with the test
result in mg/mL
Flashes when it is ready
to apply the blood sample
Displays glucose results
Appears when the meter
is turned on
If any items are missing from your kit or opened prior to use,
please contact local customer services or place of purchase for
Indicate that the displayed
test result is an average
Appears when doing a
control test and indicates
that the result won't be
stored in the memory.
Appears when set the alarm
Appears when the battery
power is low
Blood Glucose Meter
Test Strip
Each strip can be used only once. The test strip consists of the
following parts:
Where you insert the test strip. The meter will turn on
Located at the side, is for cable connection.
Slide forward to eject the test strip after test
It guides you through the test using symbols and simple
5 “M” Button
It is used to turn on the meter, enter the memory mode
It is used to set up the meter
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.
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.
Press “S” then “
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 correct month appears. Press “S”.
” “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.
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 correct hour appears. Press “S”.
1.5 Setting the minute
With the minute flashing, Press “M” until the correct minute appears. Press “S”.
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.
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.
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.
2. Press M to select General or CTL mode.
If you want to turn off an alarm, press the S button to find the n”
right alarm number and press the M button to change from “O
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 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.
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. Simplifying or changing the test procedure may produce inaccurate
testing with the control solution
A Clear Cap
Lancet Holder
Depth Indicator
Adjustable Tip
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.
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
● 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.
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.
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.
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 fmay a fect the test result.
Step 4
When the blood drop symbol flashes on the
screen, you may select the appropriate measurement mode, for selecting the measurement mode
of Control(CTL) or General, please refer to the
Step 5
Apply your blood to the absorbent hole of the test strip.
Step 6
As soon as enough blood has filled the confirmation 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.
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
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:
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
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
meter.The “ ” symbol will flash with the time and date displayed 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.
◆ 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: or
contact Metrex at 800-841-1428 for product or technical
information. CaviWipes are also available at
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
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 healthcare provider’s instruction.
1. Each disinfection step requires a pre-cleaning step.
2. If the meter is being operated by a second person who is providing 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
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)
“CDC Clinical Reminder: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne
Pathogens” (2010)
6. Table: A list of the signs of potential deterioration
(Physical and in performance)
What do you see?
The buttons do
not work
The device does
not work
What to do?
Stop using and contact local customer
services or place of purchase for
assistance, or toll free service hotline:
Stop using and contact local customer
services or place of purchase for assistance, or toll free service hotline:
Discoloration of the
buttons , meter
casing or lancing
Stop using and contact local customer
services or place of purchase for assistance, or toll free service hotline:
Corrosion, crazing,
embrittlement, cracking of the buttons,
meter casing, display
or lancing device
Stop using and contact local customer
services or place of purchase for assistance, or toll free service hotline:
Cloudiness of the
Stop using and contact local customer
services or place of purchase for assistance, or toll free service hotline:
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
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 indication
Do this:
The aging
of the strip
The meter cannot be
turned on when Inserting the test strip
several times.
please contact local customer services or place
of purchase for assistance,
or toll free service hotline:
The clouding of the
The aging
of the electronic
The content displayed please contact local cuson the lens cannot be tomer services or place
of purchase for assistance,
recognized clearly.
or toll free service hotline:
The results are not
accurate when the
test strips are in
normal mode.
please contact local customer services or place of
purchase for assistance,
or toll free service hotline:
※ The blood Monitoring System is not intended for use on neonates.
※ 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 substances 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.
※ The following compounds, when determined to in excess of
their limitation, may produce inaccurate results:
Ascorbic acid
Uric acid
※ Patients undergoing oxygen therapy may yield falsely lower
※ 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.
Blood glucose level is The message indicates
very low blood sugar. You
lower than 20mg/dl
should consult with your
healthcare professional.
Blood glucose level is This indicates sever
higher than 600 mg/dl hyperglycemia (high
blood glucose).
You should seek immediate medical assistance.
Meter is ready to test Please place a drop of
control solution under control solution onto the
test well of test strip.
the CTL state.
Battery power is low.
Please change the
Use a used test strip.
Please use a new strip
and re-test.
Error massage indicates Try again with a new
that you may remove the test strip.
strip after applying blood
to the absorbent hole.
Problem with the meter.
Re-test with a new test
strip. If the problem is
still unsolved, please
call the Customer Care
Line for help.
Environmental temperature is lower than
10 (50 ) or higher
than 40 (104 )
Please test at an environmental temperature
Display remains 1. Battery may be
1.Install the Battery
blank after the
installed improperly. correctly.
test strip has
2. Battery power is
2.Replace with new
been inserted
too low for use.
into the Meter. 3. Too much time has 3.Reinsert the Test
passed between
Strip into the
inserting the Test
Strip and performing the test.
4. Test Strip has not
been fully inserted
into the Meter.
4. Reinsert the Test
Strip into the Meter.
Test results 1. Not enough sample 1. Redo test with new
test strip and make
in the Test Strip.
are incon
sure that enough
2. Test Strip or Control
sistent or
Solution has expired. sample has been
Solution test 3. Test Strip has been
2. Redo test with new
damaged due to
results are
test strip.
heat or humidity so
not within
that sample cannot 3. Perform a Control
the specified
Solution test using a
be applied or the
new Test Strip. If
speed of applying
results are still out of
sample is too slow.
range, replace with
4. System is not pernew vial of Test Strips.
forming due to the
environment being 4. Bring System to a
room temperature
above or below
environment and
room temperature.
wait approximately 30
minutes before performing a new test.
The Meter countdown did
not start.
Test Strip has not
been inserted
Use a new Test Strip
and redo the test.
VER 1.1
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