TysonBio EZ Smart-608 User manual

Blood Glucose Monitoring System
User’s Manual
For in vitro diagnostic use only

User’s Manual

Important Information .................................................................................3
Introduction...................................................................................................7
About the Product.........................................................................................8
About the EZ Smart-608 Meter..................................................................9
About the EZ Smart-608 Test Strip..........................................................10
About the EZ Smart-608 Test Strip vial ....................................................11
About the Glucode Chip...........................................................................11
Installing/Replacing the battery................................................................12
Setting Up the Meter....................................................................................13
Checking the performance of your EZ Smart-608 Meter..........................15
Coding your EZ Smart-608 Meter............................................................15
The Control Solution Test..........................................................................16
Testing your Blood Glucose Level............................................................20
Preparing the Test Strip.........................................................................21
Obtaining a blood sample........................................................................22
Applying blood sample to the EZ Smart-608 Test Strip..........................23
Table of Contents
1

Memory Features........................................................................................25
PC Link Function........................................................................................26
Care and Storage........................................................................................28
Display Messages.......................................................................................30
Specications..............................................................................................36
Limitations of the procedure.....................................................................38
Service and Warranty..................................................................................39
Customer Service.......................................................................................41
2

Available Alternative Sites Testing : Palm and Forearm
EZ Smart-608 Blood Glucose Monitoring System provides you alternative
sites testing (AST). This system provides you to test on the palm and the
forearm with the equivalent results to ngertip testing.
There are limitations for doing AST.
Please consult your healthcare profes-
sional before you do AST.
Forearm
Palm
Important Information
3

Alternative site results differ from ngertip results when glucose levels are
changing rapidly such as after a meal, after taking insulin, during exercise,
or when you are ill or under stress. Use blood from a ngertip rather than an
alternative site if:
● you think your blood glucose is low,
● you don’t regularly have symptoms when your blood glucose is low, or
● how you feel doesn’t match the results from the alternative site.
● When you have just taken insulin, or any time during or after exercise.
● When there are unknown variables occurring in your day, such as illness.
● Whenever you are about to drive.
1. Physiologic differences in the circulation between the nger and other test
sties like the forearm and palm may result in differences in blood glucose
measurements from the other test sites and your ngertips. Changes in
4

blood glucose may be observed in nger blood samples sooner than blood
samples from the forearm and other alternate sites. Rub the alternate test
sties about 20 seconds before lancing. If you are testing for hypoglycemia
(low blood glucose), or if you suffer from hypoglycemia unawareness, we
recommend that you test on your ngertips.
2. Talk to your doctor to see if alternative site testing is right for you. With a
little bit of education, you can give your ngertips a rest and maybe test
more often than you do now. For people with diabetes, more frequent test-
ing is a good thing. Just remember: any time you want to be sure of an ac-
curate, up-to-date blood glucose reading, test on your ngertip.
3. We strongly recommend you do AST ONLY in the following intervals:
● 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 exercise.
5

● Low or high blood glucose readings can indicate a potentially serious med-
ical condition. If your blood glucose reading is unusually low or high, or if
you do not feel the way your reading indicates, repeat the test with a new
test strip. If your reading is not consistent with your symptoms or if your
blood glucose result is less than 60 mg/dL (3.3 mmol/L) or higher than 240
mg/dL (13.3 mmol/L) you should contact your healthcare professional and
follow his or her treatment advice.
● Any change or administer of medication based on the EZ Smart-608 blood
glucose test results without the consent and advice of a physician or
healthcare professional is not recommended.
● Severe dehydration and excessive water loss may cause false low results.
If you believe you are suffering from severe dehydration, consult your phy-
sician immediately.
6

Thank you for choosing the EZ Smart-608 Blood Glucose Monitoring Sys-
tem, the latest advancement in biosensor technology. As you already know,
self monitoring of blood glucose (SMBG) is a necessary part of the treatment
plan of people with diabetes mellitus. The Diabetes Control and Complica-
tions Trial (DCCT) has conrmed the signicant benets from SMBG when
practiced as part of a larger intensive strategy to tightly control blood glucose
concentrations.
Adapted for its ease of use and quick response time, the EZ Smart-608 Sys-
tem has the ability to process accurate results utilizing only a small volume
of blood for in vitro diagnostics. The EZ Smart-608 Blood Glucose Monitoring
System is intended for use in the home and in professional settings to moni-
tor whole blood glucose levels obtained from the ngertip, palm and forearm.
This is an over the counter (OTC) product.
Please read the entire User’s Manual carefully before using this prod-
uct.
Introduction
7

Your EZ Smart-608 System is made up of several components. This booklet
is designed to guide you through the operation of the system with detailed
directions and pictures.
Your EZ Smart-608 System contains:
■ EZ Smart-608 Meter
■ One vial of EZ Smart-608 Test Strips (10 strips)
■ One Glucode Chip(outside the strip vial)
■ One Lancing Device (Optional)
■ Ten Lancets (Optional)
■ One carrying case
■ User’s Manual
■ Log book (Optional)
■ Quick Reference Guide
■ One vial of Control solution(Optional)
Note: 25, 50 test strips vial can be purchased individually.
About the Product
8

3. S Button The S (select/set) button is used to select the year, month, day,
time, memory of results and control solution mode.
4. Test port This is where you insert the Test Strip into the Meter.
5. Unit Switch Switch for mmol/l or mg/dL. 6. Battery Cover 7. Label
8. Reset Button Press this button to re-set the system.
9. Glucode Chip Insert the Glucode Chip for coding.
10.Data port Connect interface cable to transfer data.
About the EZ Smart-608 Meter
1. Display Your test results are displayed
here. The large, easy to read screen
guides you through the test by using
numbers and symbols.
2. M Button The M (mode) button is used
to set the year, month, day, time, enters
the memory mode to show the consec-
utive 14-day average results and turns
the Meter on and off.
The FRONT The BACK
9
2
4
8
10
3
1
5
7
M
S
mg/dL
RESET
mmol/l mg/dL
S/N:M05B13286
Blood glucose Meter
Forin vitro diagnostic
useonly
Manufacturedby:
TysonBioresearch.Inc.
Chu-Nan,Taiwan
CustomerSer vice
Call:[phone]
serv[email protected]m
TysonID:T502
0537
4 719869 700353
6
9

BACKFRONT
The EZ Smart-608 Test Strip is used to perform
the blood glucose test in conjunction with the EZ
Smart-608 Meter. Each strip can be used only
once.
The EZ Smart-608 Test Strip consists of the follow-
ing parts:
1. Confirmation Window This is where you can
confirm that enough blood has been applied to
the target area.
2. Target Area This is where blood is drawn into the
Test Strip.
3. Contact Bar This end of the Test Strip is inserted
into the meter Test Port to activate the Meter.
(white side face up)
About the EZ Smart-608 Test Strip
10
3
1
2
5-5D

About the EZ Smart-608 Test Strip Vial
About the Glucode Chip
Blood Glucose Test Strips
Do not store test strips
outside this vial.
Store at 4-30°C(39-86°F)
For the measurement of
glucose in whole blood.
10 Test Strips
Do not refrigerate. Re-cap immediately.
For
in vitro diagnostic use.
956
Lot#: G3T131036
Exp: May.2010
31-61
84-144
348-438
1.7-3.4
4.7-8.0
19.3-24.3
Use EZ Smart-608 only!
0537
Code
VIAL LABEL
Lot Number
Expiration Date
Code Number
Control Solution Range
TEST STRIP VIAL
The Glucode Chip is used to ensure that your EZ Smart-608
Meter provides you with accurate results. Before perform-
ing the blood glucose test or starting a new strip vial, please
check your Meter with the Glucode Chip to ensure proper
performance (further instructions for use of the Glucode Chip
is provided on page 15). After checking your Meter, the Glu-
code Chip is also used to code setting.
956
CODE Number
11

■ Note: Always use the Glucode Chip to ensure your EZ Smart-608 Meter is
performing properly.
■ DO NOT misplace your Glucode Chip.
The EZ Smart-608 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 sig-
nal. When this display appears, it is time to replace a new
battery. When the low battery warning signal is shown, the
EZ smart-608 Meter will provide accurate results for ap-
proximately 50 more measurements.
How to Replace the Battery
1. From the back of the Meter, gently slide and remove the
battery cover.
2. Insert a 3-Volt lithium battery (CR-2032) with the “+” side
facing up.
3. Slide battery cover back into place.
Installing/Replacing the battery
12

Setting Up the Meter
To turn the Meter on, first put the battery into the battery chamber, then
press the reset button located at the back of the Meter and proceed with the
following instructions.
Setting Up the Date, Time, Unit and Enter PC Link Mode
1. Press and hold the Mbutton for 3 seconds. The Meter is
now in the setting mode.
2. The Year setting will be the first to appear. Press and
release the S button until the correct year appears. With
the correct year on the display, press the M button and
the month and date setting will appear.
3. Press and release the S button until the correct month
appears. With the correct month on the display, press
and release the M button and the day setting will ash.
M
S
4. Press and release the S button until the correct day appears. With the
correct day on the display, press and release the Mbutton to bring up the
hour and minute display. 13

5. Press and release the S button until the correct hour appears. With the
correct hour on the display, press the Mbutton and the minute display will
ash.
6. Press and release the S button until the correct minute appears. When the
correct minute is on the display, press the Mbutton to move on to PC link
mode.
7. If you press S button (yes), it will appear “PC” link mode for
transferring test data. Further instruction of transferring test
data, see page.22. To nish setting, press Mbutton (no) to
turn off the meter. Your programmed settings will be shown
on the display every time you use the Meter.
Code Setting and Unit Selection
1. Select unit, mg/dL or mmol/l on the back.
(The mg/dL is the standard unit in the
United State)
2. Plug the Glucode Chip into the Glucode
Chip slot for strip coding.
RESET
mmol/l mg/dL
S/N:M05B13286
Bloodglucose Meter
Forin vitro diagnostic
useonly
Manufacturedby:
TysonBioresearch.Inc.
Chu-Nan,Taiwan
CustomerService
Call:[phone]
serv[email protected]m
TysonID:T502
0537
4 719869 700353
mmol/l mg/dL
14

The Glucode Chip is used for checking and coding your EZ Smart-608 Meter.
To Check your Meter:
1. Insert the Glucode Chip into meter’s Glucode Chip slot.
All segments of the LCD display will appear indicating
that the Meter is functioning properly.
2. If you are a rst time user or start a new strip vial, please
continue the coding procedure.
DAY AM
PM
AVG
Memmmol/l mg/dL
Codectl
Checking the Performance of your EZ Smart-608 Meter
Coding your EZ Smart-608 Meter
Each batch of EZ Smart-608 Test Strip is encoded with a number that must
match one of the code numbers stored in the EZ Smart-608 Meter. In or-
der to ensure an accurate result, the code number on the display must also
match the code number found on the Test Strip vial.
1. Insert the Glucode Chip into the Glucode Chip slot. The Meter will auto-
matically be encoded.
Note:Code the Meter whenever you start a new test strip vial.
15

DAY AM
PM
AVG
Memmmol/l mg/dL
Codectl
Code
2. All segments of the LCD display will appear indi-
cating that the Meter is functioning properly. Then a
beep will sound, followed by the code number.
3. Match the code number on the Meter display with
the code number on the Test Strip vial label. If the
code matches, you may begin to test.
4. If the meter code and vial code do not match,
please ask the store/distributor to replace a new
vial .
The Control Solution is used to check and ensure that the EZ Smart-608
Meter and EZ Smart-608 Test Strip are working together properly and that
you are performing the test correctly. For an accurate reading, check the
system with the Control Solution on a routine basis (approximately once a
week).
The Control Solution Test
16

NOTE :
1. Control Solutions are required but not supplied.
2. There are three Control Solutions at different desired range of aqueous
glucose (Low, Normal or High). For more information about the Control
Solution, please read your Control Solution package insert. Two sets of
control solution should be used, a high level and a low level control solu-
tion of your choice.
To perform a Control Solution Test:
1. Insert the Test Strip,
white side face up,
Contact Bar’s end
first, into the test
port. The Meter will
automatically turn on.
2. All segments of the
LCD display will ap-
pear, indicating that
the Meter is function-
ing properly.
M
S
DAY AM
PM
AVG
Memmmol/l mg/dL
Codectl
17

3. A beep will sound and the code number will appear fol-
lowed by a ashing “ ” symbol. Be sure the code number
on the display matches the code number on the Test Strip
vial. If the code numbers do not match, code the Meter
by using Glucode Chip, accordingly.
4. After the “ ” symbol appears, press the S button for 3 sec
to switch “ctl” mode. The “ctl” symbol indicates that the
Meter will mark your current test as a Control Solution
test. Now you are ready to apply the Control Solution.
5. Discard the rst drop of Control Solution and squeeze a
small drop of Control Solution on a clean nonabsorbent
surface (such as a clean piece of wax paper). Do not
apply Control Solution to the Test Strip directly from the
bottle.
6. Bring the tip of the Test Strip to lightly touch the drop of
Control Solution. Control Solution is automatically pulled
into the strip through the tip. Hold until the meter beeps.
The meter will now being counting down from 8 to 1 and
the Control Solution test result will appear.
AM
mg/dL
ctl
18
M
S