EZ Smart 606 User manual

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Table of Contents
Introduction..........................................................................................................................
About the Product.............................................................................................................
About the EZ Smart-606 Meter....................................................................................
About the EZ Smart-606 Test Strips..............................................................................
About the EZ Smart-606 Test Strip vial..........................................................................
About the Glucode Chip.........................................................................................
Installing/Replacing the battery.....................................................................................
Setting up the Meter............................................................................................................
Coding your EZ Smart-606 Meter...........................................................................................
The Control Solution Test...........................................................................................................
Testing your Blood Glucose Level...........................................................................................
Preparing the Test Strip...................................................................................................
Obtaining a blood sa ple....................................................................................
Applying blood sa ple to the EZ Smart-606 Test Strip.........................................................
Memory Features..............................................................................................................
Care and Storage.............................................................................................................
isplay Messages.........................................................................................................
Specifications....................................................................................................
Li itations of the Procedure...........................................................................................
Service and Warranty.......................................................................................................
Customer Service............................................................................................................................
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About the Product
Your EZ Smart-606 Syste is ade up of several co ponents. This booklet is designed to guide
you through the operation of the syste with detailed directions and pictures.
Introduction
Congratulations on choosing the EZ Smart-606 Syste , the latest advance ent in biosensor
technology. Adopted for its ease of use and quick response ti e, the EZ Smart-606 has the ability
to process accurate results utilizing only a s all volu e of blood for in vitro diagnostics. The EZ
Smart-606 Syste s intended use is to provide a convenient and safe onitoring syste for
diabetic individuals. This is an over the counter(OTC) product.
Technically, blood glucose is oxidized enzy atically when the electrical current generated by
glucose oxidation is easured. The advantage of using the Syste co es fro the EZ Smart-
606 Test Strips, which is specially designed to allow the onitoring of your blood glucose level
quickly and easily. What akes the EZ Smart -606 Test Strip so special is on how blood sa ples
are drawn. Our unique design allows you to use a s all a ount of blood to produce results in only
a short ti e.
Your EZ Smart-606 System contains:
vEZ Smart-606 Meter
vOne vial of EZ Smart-606 Test Strips (10 strips)
vOne Glucode Chip (outside the strip vial)
vOne Lancing Device (Optional for co pact kit)
vTen Lancets (Optional for co pact kit)
vOne carrying case
v
vLog book (Optional for co pact kit)
vQuick Reference Guide
vOne vial of Control Solution (Optional for
co pact kit)
Note: 25, 50 test strips vial can be purchased individually.
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About the EZ Smart-606 Meter
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The FRONT
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1. isplay Your test results are displayed here.
The large, easy to read screen guides you
through the test by using nu bers and
sy bols.
2. M Button
3. S Button
4. Test port This is where you insert the Test
Strip into the Meter.
The BACK
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5. Battery Cover
6. Unit Switch Switch for ol/l or g/dL.
7. Label
8. Reset Button Press this button to re-set
the syste .
9. Glucode Chip Insert the Glucode Chip for
coding.
P. 4
About the EZ Smart-606 Test Strip
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The EZ Smart-606 Test Strip is used to perfor the blood glucose test in conjunction with the EZ
Smart-606 Meter. Each strip can be used only once.
The EZ Smart-606 Test Strip consists of the following parts:
1.Confirmation Window This is where you can confir that enough blood has been applied to
the target area.
2.Targe t Area This is where blood is drawn into the EZ Smart-606 Te st S tr ip .
3.Contact Bar This end of the EZ Smart-606 Test Strip is inserted into the Test Port to activate the
EZ Smart-606 Meter. (white side face up)
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About the EZ Smart-606 Test Strip Via
EZ Smart-606 Control Solution Range
Code Number Exp. Date
Lot Number
About the G ucode Chip
The Glucode Chip is used to ensure that your EZ Smart-606 Meter provides you with accurate
results. Before perfor ing the blood glucose test or starting a new strip vial, please check your
EZ Smart-606 Meter with the Glucode Chip to ensure proper perfor ance (further instructions
for use of the Glucode Chip is provided on page 7). After checking your Meter, the Glucode Chip
is also used to code setting.
CODE Nu ber
vNote: Always use the Glucode Chip to ensure your EZ Smart-606 Meter is perfor ing properly.
vO NOT isplace your Glucode Chip.
P. 6
Insta ing/Rep acing the battery
The EZ Smart-606 Meter uses one 3-Volt lithium battery (CR-2032).
When to Replace the Battery
When the battery is low, the Meter will show a warning signal. When this
display appears, it is ti e to replace a new battery. When the low battery
warning signal is shown, the EZ Smart-606 Meter will provide accurate results
for approxi ately 50 ore easure ents.
How to Replace the Battery
1. Fro the back of the Meter, gently slide and re ove the battery cover.
2. Insert a 3-Volt lithiu battery (CR-2032) with the + side facing up.
3. Slide battery cover back into place.
Setting Up the Meter
To turn the Meter on, first pull the plastic tab out from the battery chamber, then press the reset button
located at the back of the Meter and proceed with the following instructions.
1. Select unit, g/dL or ol/l on the back.
Code Setting and Unit Selection
2. Plug the Glucode Chip into the Glucode Chip slot for strip coding.
P. 7
Coding your EZ Smart-606 Meter
Each batch of EZ Smart-606 Test Strip is encoded with a nu ber that ust atch one of the code
nu bers stored in the EZ Smart-606 Meter. In order to ensure an accurate result, the code nu ber
on the display ust also atch the code nu ber found on the EZ Smart-606 Test Strip vial.
1. Insert the EZ Smart-606 Glucode Chip into the Glucode Chip slot.
The EZ Smart-606 Meter will auto atically be encoded.
Note: Code the EZ Smart-606 Meter whenever you start a new
Test Strip vial.
2. All seg ents of the LCD display will appear indicating that the EZ
Smart-606 Meter is functioning properly. Then a beep will sound,
followed by the code nu ber.
3. Match the code nu ber on the EZ Smart-606 Meter display with
the code nu ber on the EZ Smart-606 Test Strip vial. If the code
atches, you ay begin to test.
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The Contro So ution Test
The Control Solution is used to check and ensure that the EZ Smart-606 Meter and EZ Smart-606
Test Strip are working together properly and that you are perfor ing the test correctly. For an
accurate reading, check the syste with the EZ Smart-606 Control Solution on a routine basis
(approxi ately once a week).
NOTE :
1. Control Solutions are required but not supplied.
2. There are three EZ Smart-606 Control Solutions at different desired range of aqueous
glucose (Low, Nor al or High). For ore infor ation about the EZ Smart-606 Control Solution,
Please read your EZ Smart-606 Control Solution package insert. Two sets of control solution
should be used, a high level and a low level control solution of your choice.
1. Insert a EZ Smart-606 Te st S tr ip ,
white side face up, Contact Bars
end first, into the test port. The
EZ Smart-606 Meter will auto-
atically turn on.
To perform a Control Solution test:
2. All seg ents of the LCD dis-
play will appear, indicating
that the EZ Smart-606 Meter
is functioning properly.
3. A beep will sound and the code nu ber will appear followed by a flashing S
sy bol. Be sure the code nu ber on the display atches the code nu ber on the
EZ Smart-606 Test Strip vial. If the code nu bers do not atch, code the EZ
Smart-606 Meter by using Glucode Chip, accordingly.
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4. After the S sy bol appears, press the M button for 3 sec to switch the
ctl sy bol. The ctl sy bol indicates that the Meter will ark your current
test as a Control Solution test. Now you are ready to apply the Control Solution.
5. Discard the first drop of Control Solution and apply a s all drop of Control
Solution onto your fingertip. Then, place this drop of Control Solution onto the
target well area.
6. As soon as enough solution has been drawn into the Confir ation Window, the
EZ Smart-606 Meter will beep and begin counting down fro 8 to 1 and the
Control Solution test result will appear.
Caution: Please remember that in order to prevent contamination, follow
the above instructions for preforming the Control Solution test.
Results falling outside the specified range may be caused by:
vError in perfor ing the test
vExpired or conta inated Control Solution
vExpired or conta inated EZ Smart-606 Te st S tr ip s
vI proper coding of the EZ Smart-606 Meter
vEZ Smart-606 Meter alfunction
Comparing Control Solution Results
The EZ Smart-606 is functioning properly if the result falls inside the specified range printed on the Test
Strip vial. If the test result falls outside the specified range, repeat the test.
Note: The result will not be stored into the e ory and will not be incorporated
into the average in the ctl ode.
O NOT use the syste if the proble persists. Please call Tyson Bioresearch, Inc., Custo er Services
at [phone] or website of www.tysonbio.com
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Testing your B ood G ucose Leve
Before testing blood glucose, you need the following ite s:
1. EZ Smart-606 Meter
2. EZ Smart-606 Test Strip
3. Adjustable Auto atic Lancing Device
4. Sterile Lancet
5. Glucode Chip
vNever share a lancing device and lancet with another person.
vAlways use a new and sterile lancet. Lancets are for single use only.
v
Always use a new EZ Smart-606 Test Strip. Test Strips are for single use only.
v o not get lotion, oil, dirt or debris in or on the lancet and lancing device.
Caution: To reduce the chances of infection:
Preparing the Test Strip
1.Wash hands using
soap and war
water.Rinse and
dry thoroughly.
2.Pull out an EZ
Smart-606 Te s t
Strip fro the vial
and re-cap the
vial i ediately.
3.Insert the Test
Strip white side
face up, into the
test port
.
4. A beep will sound and the code nu ber will appear followed by a flashing S
sy bol. Now you are ready to obtain a blood sa ple.
Reminder: Make sure that the code nu ber on the display atches the code
nu ber displayed on the Test Strip vial. If the code nu ber on the display does
not atch the code nu ber on the Test Strip vial, code the Meter by using
Glucode Chip, accordingly.( See page 7)
P. 11
Obtaining a B ood Samp e
SAMPLE MAY BE OBTAINE FROM FINGER
For further instructions please see the insert provided with lancing device.
1. Unscrew and re ove the endcap of lancing device.
2. Insert the lancet into the lancet holder.
3. Twist and re ove the protective lancet cover to expose the sterile needle tip.
4. Recapping and unscrewing the endcap to the body of the lancing device.
5. Pull back on the cocking echanis until it co es to a stop.
6. Place the lancing device fir ly against the finger tip and press the release button.
PERFORM THE TEST
7. After sa pling, re ove the endcap containing the used lancet carefully.
8. Re ove the lancet fro the lancing device. Discard the used lancet properly in accordance with
local, state, and federal law.
App ying b ood samp e to the EZ Smart-606 Test Strip
1. After obtaining a blood
sa ple, place the drop onto
the test well of
the EZ Smart-606 Tes t
Strip.
2. Blood is auto atically
drawn into the EZ
Smart-606 Test Strip.

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3. As soon as enough blood has
filled the Confir ation Window
(see picture) of the Test Strip,
the EZ Smart-606 Meter will
beep and begin counting down
fro 8 to 1.
Confirmation Window
4. Your blood glucose result
will appear on the LCD
panel and will be stored into
the Meter e ory
auto atically.
Note:To ensure accurate results, make sure the Confir-
mation Window of the Test Strip is completely filled with
your blood sample.
5. The EZ Smart-606 results range between 20 to 600 g/dL (1.1 to 33.3 ol/l). If a
HI essage appears on your display, your EZ Smart-606 Meter has detected
that your blood glucose level is higher than 600 g/dL(33.3 ol/l). It is suggested
that you review your testing procedure and test again with a new EZ Smart-606
Test Strip to confir the result. If the same result occurs, consult your
healthcare professional immediately.
6. If a Lo essage appears on your display, your EZ Smart-606 Meter has de-
tected that your blood glucose level is lower than 20 g/dL (1.1 ol/l). It is
suggested that you review your testing procedure and test again with a new EZ
Smart-606 Test Strip to confir the result. If the same result occurs, consult
your healthcare professional immediately.
If no further tests are perfor ed, the EZ Smart-606 Meter will auto atically shut
off after 4 inutes.
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After finishing the test, we reco end using a tissue paper to re ove EZ Smart-
606 Test Strip fro the EZ Smart-606 Meter for proper disposal.
Caution:
Any change or administer of medication based on the EZ Smart-606 blood
glucose test results without the consent advice of a physician or
healthcare professional is not recommended.
Memory Features
The EZ Smart-606 Meter automatically stores the 28 most recent blood glucose results. It also provides you
with an average of your blood glucose test results.
1. Press the M button to
turn on the EZ Smart-
606 Meter.
2. All segments of the LCD display
will appear.
3. The 28 set data aver-
age will automati-
cally appear, and
flash for few seconds.
4. The most recent test result(1 st set) will
automatically appear.
Press the M button, the Meter displays
the data order release the M botton
shows its reading, accordingly. When the
28 memories are full, the oldest result is
removed and replaced with the newest
result.
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Exiting the Memory Mode
1. Press and release the M button to the end of the e ory(000 will show). Press the S button
again to turn the eter off.
2.Meter will shut down auto atically after 15 seconds with no further action.
Results arked as ctl (Control Solution) will not be averaged into the nor be stored into the
e ory.
Care and Storage
1. Handle the EZ Smart-606 Meter with care. Dropping or throwing the Meter ay cause da -
age to the device.
2. Do not expose the Meter, Test Strips, and Control Solution to extre e conditions, such as high
hu idity, heat, freezing cold or dust.
3. Always wash hands with soap and water and rinse and dry co pletely before handling the
Meter and Test Strips.
4. When cleaning the Meter, gently wipe the exterior surface using a da p soft cloth. O NOT
USE ANY ORGANIC SOLVENT for cleaning.
5. The Meter should be stored at roo te perature in a dry and clean space. O NOT STORE
IN IRECT SUNLIGHT OR AREAS WITH HIGH HUMI ITY AN /OR UST. It is advised
that you store the Meter and its accessories into the provided carrying case.
We have provided a log book for your recording convenience. To learn more about how to record
your results, please refer to the log book for further instructions.
P. 15
For healthcare professionals using this syste on ultiple patients, please be aware that all
ite s that co e in contact with hu an blood should be handled as potential biohazards.
Users should follow the guidelines for prevention of blood-borne trans ittable diseases in a
healthcare setting for potentially infectious hu an blood speci ens as reco ended in the
National Co ittee for Clinical Laboratory Standards, Protection of Laborator Workers from
Instrument Biohazards and Infectious Disease Transmitted b Blood, Bod Fluids and Tissue:
Approved Guideline.
NCCLS document M29-A [ISBN 1-56238-339-6].
Disp ay Messages
DISPL Y WH T IT ME NS CTION
Syste check verifying that all seg-
ents of the Meter are functioning.
This essage appears i edi-
ately if your Meter has not been
encoded.
No Action Necessary
Code Meter
(see page 7)
This is the current code nu ber
in use.
This code nu ber should
atch the code nu ber
printed on your EZ Smart-
606 Test Strip vial.
P. 16
DISPL Y WH T IT ME NS CTION
The syste is ready to accept a blood
sa ple.
The syste is ready to accept a Con-
trol Solution sa ple.
EZ Smart-606 Meter detects blood
glucose level is higher than 600 g/
dL(33.3 ol/l).
The EZ Smart-606 Meter detects
blood glucose level is lower than 20
g/dL (1.1 ol/l).
You ay now apply a blood sa ple.
You ay now apply a drop of Con-
trol Solution sa ple.
Indicates high blood glucose level.
Repeat test. If result still occurs,
consult your physician i ediately.
Indicates low blood glucose level.
Repeat test. If result still occurs,
consult your physician i ediately.
P. 17
DISPL Y WH T IT ME NS CTION
Te perature is too low to
perfor the test.
Te perature is too high to
perfor the test.
An error essage indicating a
proble with the EZ Smart-606
Test Strip or Glucode Chip.
An error essage indicating a
proble with the EZ Smart-606
Meter.
Repeat the test in a war er setting
(10 - 40oC or 50 - 104oF). Wait 15
inutes before re-testing.
Repeat the test in a cooler setting
(10 - 40oC or 50 - 104oF). Wait 15
inutes before re-testing.
Review the instructions and try
again with a new EZ Smart-606 Tes t
Strip or Glucode Chip.
Check the eter again with the
Glucode Chip. If the proble
persists, contact Tyson Bioresearch,
Inc. Custo er Service for help.
P. 18
DISPL Y WH T IT ME NS CTION
Battery power is too low for fur-
ther usage.
Battery power is low. Meter will
provide approxi ately 50 ore
easure ents.
All testing values recorded in the
e ory have been shown.
Replace with a new 3-Volt lithiu
battery (CR-2032).
Replace with a new 3-Volt lithiu
battery (CR-2032).
Press S button or wait for 15 sec-
onds to turn off the eter.
An error essage indicating a prob-
le with the coding of EZ Smart-
606 Meter.
Check the eter again with the
Glucode Chip. If the proble
persists, contact Tyson
Bioresearch, Inc. Custo er Ser-
vice for help.
P. 19
Other problems that may occur CTION
The EZ Smart-606 Test Strip has not been
inserted into the Meter properly.
Review the instructions and re-insert the
Test Strip correctly(white side face up).
Defective EZ Smart-606 Test Strip. Replace with a new EZ Smart-606 Te st
Strip.
Insufficient blood sa ple. Repeat the test with new EZ Smart-606
Tes t S tr ip .
Test Strip re ains in the test port for ore
than 4 inutes prior to testing.
Meter will auto atically turn-off.
Re-insert the Test Strip to the test port.
LCD Screen on the Meter is blank when trying
to prefor a test.
Contact Tyson Bioresearch, Inc.
Custo er Service for help.
P. 21
vThe Lancets are in conformity with the MDD 93/42/EEC
Wuxi Xinda
Medical Device Co., Ltd.
No.42 Xixin Road, Zhangjing
Wuxi, Jiangsu,214194,PRC
[phone]
vThe Lancing Device is being clasifie as MDD Class I
Limitations of the Procedure
Caution: The EZ Smart-606 Syste is designed for in vitro use only and is not intended to test
on newborns.
The EZ Smart-606 Test Strips are designed for use with fresh capillary whole blood sa ples.
False results ay occur when perfor ing the test while severely dehydrated, severely
hypotensive, in shock or in a hyperglyce ic-hyperos olar state. If you believe you are
suffering fro any of the above sy pto s, consult a healthcare professional i ediately.
EMDAR BV
Ijsselburecht 3, Postbus 5486
6802 EL Arnhe , Netherlands
[phone]
Wuxi Xinda
Medical Device Co., Ltd.
No.42 Xixin Road, Zhangjing
Wuxi, Jiangsu,214194,PRC
[phone]
EMDAR BV
Ijsselburecht 3, Postbus 5486
6802 EL Arnhe , Netherlands
[phone]
P. 22
Service and Warranty
IMPORTANT: The EZ Smart-606 Blood Glucose Monitoring Syste is designed for in vitro
diagnostic use only. Tyson Bioresearch Inc. cannot endorse the perfor ance of the EZ Smart-
606 Syste when used with Test Strips other than those designed for the EZ Smart-606
Meter. The EZ Smart-606 Syste anufacturer warranty is valid only when used properly
within the guidelines of the provided Users Manual and is invalid when the EZ Smart-606
Syste and EZ Smart-606 Test Strip are used i properly.
Manufacturer Warranty: Tyson Bioresearch, Inc. guarantees that this device will be free of
defects in aterials and work anship for a period of three years fro the date of original purchase.
During the stated three-year period, our co pany shall repair or replace any EZ Smart-606 Meter
found defective with a new EZ Smart-606 Meter.
This warranty does not apply to the perfor ance of a EZ Smart-606 Meter that has been acciden-
tally da aged, altered, isused, ta pered with or abused in any way. In no event shall our
co pany be liable to the purchaser or any other person for any incidental, consequential, or
punitive da ages arising fro or in any way connected with the purchase or operation of the EZ
Smart-606 Meter or its parts.
For manufacturer warranty services, purchaser must contact Tyson Bioresearch, Inc for
help
P. 23
Customer Service
If you have any questions or concerns regarding this product and or its operation, or any atte pt
to correct a proble fails, please call our Custo er Service Unit. Our trained specialists will be
happy to assist you, train you, or even reaffir your results.
Customer Service Hotline:
886-37-585998
our office hours are from
8:30am (GM 0030) - 5:30pm (GM 0930)
or E-Mail us at
[email protected]
When you call our Custo er Service Unit, please have your EZ Smart-606 Meter, EZ Smart-606
Test Strip and all other syste supplies available. This will allow us to answer any of your ques-
tions with speed and efficiency.