Home Aide Diagnostic Easy Step User manual

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

Important Information ...................................2
Introduction ...................................................5
About the Product .........................................6
About the Meter .........................................7
About the Meter display ............................8
About the Test Strip ...................................9
About the Test Strip vial ............................9
Installing/Replacing the battery ..............10
Setting Up the Meter ...................................11
Setting up the date, time ........................11
Setting up alarm .....................................12
Unit selection ...........................................13
The Control Solution Test ..............................14
Testing Your Blood Glucose Level ................17
Preparation for testing..................................17
Obtaining a blood sample ...........................18
Applying blood sample to the Test Strip.......19
Memory Features..............................................21
Transfer Test Results to a Computer ............23
Care and Storage ............................................24
Display Messages ...........................................25
Specications ..................................................30
Limitations of the procedure ........................31
Service and Warranty .....................................31
Customer Service.............................................33
Table of Contents
1

Available Alternate Sites Testing : Palm and Forearm.
Easy Step Blood Glucose Monitoring System provides you with alternate site testing (AST). This
system allows you to test on the palm and the forearm.
There are limitations for doing AST. Please consult your
healthcare professional before you do AST.
Alternate 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 alternate 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 alternate 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.
CAUTION:
1. Physiologic differences in the circulation between the nger and other test sites like the forearm and
palm may result in differences in blood glucose measurements from the other test sites and your
ngertips. Changes in blood glucose may be observed in nger blood samples sooner than blood
samples from the forearm and other alternate sites. Rub the alternate test sites about 20 seconds
before lancing. If you are testing for hypoglycemia (low blood glucose), or if you suffer from hypo-
glycemia unawareness, we recommend that you test on your ngertips.
2. Talk to your doctor to see if alternate 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 testing is a good thing. Just remember: any time you want to be sure of an accurate,
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.
Important Information
Palm
Forearm
32

DO NOT use AST if:
● You think your blood glucose is low.
● You are unaware of hypoglycemia.
● Your AST results do not match the way you feel.
● You are testing for hyperglycemia.
● Your routine glucose results are often uctuating.
● If you are pregnant.
● Low or high blood glucose readings can indicate a potentially serious medical 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 Easy Step 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 physician immediately.
Thank you for choosing the Easy Step Blood Glucose Monitoring System, 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 Complications
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 Easy Step System has the ability to process
accurate results utilizing only a small volume of blood for in vitro diagnostics. The Easy Step Blood
Glucose Monitoring System is intended for use in the home and in professional settings to monitor
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 product.
Introduction
54

About the Easy Step Meter
1. Display Your test results are displayed here. The large,
easy to read screen guides you through the test by us-
ing numbers and symbols.
2. M Button The M button is used to set time, select, enter
the memory mode to show the most recent result and
turn the Meter on and off.
3. S Button The S button is used to set alarm, select year,
month, day, time, enter control solution mode and read
consecutive 7/14/30-days average results.
4. Test Port This is where you insert the Test Strip into
the Meter.
5. Unit Switch Switch for mmol/l or mg/dL.
1 mmol/l =18 mg/dL
6. Battery Cover
7. Label
8. Reset Button Press this button to re-set the system.
9. Data Port Connect interface cable to transfer data.
10. Strip Ejection Button Push button to eject the used
strip.
11. Backlight Button Turn backlight on and off. If ON, it will
stay ON for 30 seconds and turn off automatically.
Your Easy Step 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 Easy Step System Kit contains:
● Easy Step Meter
● One vial of Easy Step Test Strip (10 strips)
● One Lancing Device
● Ten Lancets
● One Control Solution
● One carrying case
● User’s Manual
● Log book
● Quick Reference Guide
About the Product
76
Meter only contains:
● Easy Step Meter
● One carrying case
● User’s Manual
● Quick Reference Guide
● Log book
Front Back
Easy Step
RESET
mmol/l mg/dL
11
Easy
Step
Blood Glucose Monitor
Model: T502-73802
Home Aide Diagnostics, lnc
Tel.: [phone]
www.homeaide.us
Made in Taiwan

Store at 4-30°C ( 39-86°F). Do not refrigerate.
Do not store test strips outside this vial.
Re-cap immediately. Do not reuse.
WARNING: Always close lid tightly.
For testing of glucose in capillary whole blood.
For in vitro diagnostic use.
Use within 90 days after first opening.
Use
Easy Step meter only !
H8T121205
Aug 2011
39-69
74-134
265-355
2.2-3.8
4.1-7.4
14.7-19.7
Low:
Normal:
High:
Easy Step
Easy
Step
Distributed by
Home Aide Diagnostics
1072 S. Powerline Rd.
Deerfield Beach, FL 33442
www.homeaide.us
[phone]
About the Easy Step Meter Display
1. Date
2. Time
3. Control Solution Test
Appears when doing a control solution test and marking the
result as a control solution test.
4. Code Symbol Appears with the code number in use.
5. Memory Symbol Indicates in memory mode.
6. Units of Measurement Unit of mmol/l or mg/dL will appear
with the test result.
6
4
8
3
52
7
10
1
2
14
1
7. Battery Symbol Appears when the battery is low or must be replaced.
8. Blood Drop Symbol Flashes when it is ready to apply sample to Test Strip.
9. Alarm Function Symbol Appears when the clock alarm is set.
10. Test Strip Symbol Appears to tell you when the meter is ready for test.
11. Day Average Symbol Shows the average value of test results.
12. Test Result Area Display test results.
13. Temperature Message Appears if your meter is out of operating temperature range.
14. Meal Indicator Pre-meal and Post-meal
The Easy Step Test Strip is used to perform the blood glucose test in conjunction
with the Easy Step Meter.
Each strip can be used only once.
The Test Strip consists of the following parts:
1. Conrmation Window This is where you can conrm 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 Test Port to activate
the Meter (white side face up).
3
1
2
About the Easy Step Test Strip
About the Easy Step Test Strip Vial
Control Solution Range
Lot Number
Expiration Date
Vial Label Test Strip Vial
98
9
11 3
1
14
°F). Do not refrigerate.
outside this vial.
o
not reuse.
s
e lid tightly.
n
capillary whole blood.
se.
p
Step
buted by
e
Diagnostics
owerline Rd.
e
ach, FL 33442
meaide.us
915-0116

Installing/Replacing the Battery Setting Up the Meter
When the battery is low, the Meter will show a warning signal. When this display ap-
pears, it is time to replace a new battery. When the low battery warning signal is shown,
the Meter will provide accurate results for approximately 50 more measurements.
How to replace the battery
1. From the back of the Meter, gently slide and remove the battery cover. (Fig.1)
2. To remove the battery, simply lifting it from the bottom right hand corner. (Fig.2)
3. Insert a 3-Volt Lithium battery (CR-2032) at an angle, then press it into the battery
slot with the “+” side facing up. (Fig.3)
4. Slide battery cover back into place. (Fig.4)
To turn the Meter on, rst insert a battery, then press the reset button located at the back of the Meter
and proceed with the following instructions.
1. Press the M button for 4 sec to enter setting mode. Press and release
S button to choose “24Hr” or “12Hr” display. With your favorite clock
mode, press M button and the year setting will be appeared. Press and
release the S button until the correct year appears. (Fig.1)
2. To enter the year and move on to choose the month, press the M button.
To change the month, press the S button. (Fig.2)
3. To enter the month and move on to choose the day, press the M button.
To change the day, press the S button. (Fig.3)
4. To enter the day and move on to choose the hour setting, press the M
button. (Fig.3)
5. To change the hour, press the S button. To enter the hour and move on
to change the minutes, press the M button. (Fig.4)
6. To change the minutes, press the S button then press M button to nish
setting and turn off the meter. (Fig.4)
(Fig.1)
(Fig.2)
Easy Step
Setting up the date, time
1110
RESET
mmol/l mg/dL
1 2 3 4
(Fig.4)
(Fig.3)
RESET
3V
RESET
mmol/l mg/dL

4. To set the fourth alarm, press the M button (y). If you press S button
(n), it will turn off the meter. To change the hour, press S button. To
enter the hour and move on to change the minutes, press M button. To
change the minutes, press S button and press M button to turn off the
meter. (Fig.8)
Note: When the alarm is ringing, press S or M button to turn off or alarm
will turn off automatically after 30 sec.
(Fig.7)
(Fig.8)
Unit selection
Select unit, mg/dL or mmol/l on the back of the meter.
Note: The mg/dL is the standard unit in the United States. Meters
used in the United States must be set to read in mg/dL.
mmol/l mg/dL
RESET
mmol/l mg/dL
13
Easy
Step
Blood Glucose Monitor
Model: T502-73802
Home Aide Diagnostics, lnc
Tel.: [phone]
www.homeaide.us
Made in Taiwan
1. Press S button for 4 sec to enter this mode. To set the rst alarm,
press the M button (y). If you press S button (n), it will turn off the me-
ter. To change the hour, press S button. To enter the hour and move
on to change the minutes, press M button. To change the minutes,
press S button. To enter the minutes and move on to choose the sec-
ond alarm setting, press the M button. (Fig.5)
2. To set the second alarm, press the M button (y). If you press S button
(n), it will turn off the meter. To change the hour, press S button. To
enter the hour and move on to change the minutes, press M button. To
change the minutes, press S button. To enter the minutes and move
on to choose the third alarm setting, press the M button. (Fig.6)
3. To set the third alarm, press the M button (y). If you press S button (n),
it will turn off the meter. To change the hour, press S button. To enter
the hour and move on to change the minutes, press M button. To
change the minutes, press S button. To enter the minutes and move
on to choose the fourth alarm setting, press the M button. (Fig.7)
(Fig.5)
Setting up alarm
(Fig.6)
12

The Control Solution is used to check and ensure that the Easy Step Meter and Easy Step Test Strip
are working together properly and that you are performing the test correctly.
When to perform a control solution test
1. When you are using your Blood Glucose Monitoring System for the rst time.
2. When you are using a new batch of Test Strips.
3. Anytime you question the performance of the system, or on a regular basis to ensure accuracy,
e.g. once a week.
4. When you adjust your diabetic medication plans.
5. When your blood glucose test result is lower or higher than your normal level.
Note: Easy Step system uses three Control Solutions at different desired range of aqueous glucose
(Low, Normal or High). Two levels of control solution should be performed. Refer to your Control Solu-
tion package insert for more information. For order information, please call Customer Service.
Control Solution Test
14
1. Make sure the Control Solution is at room temperature (59 to 95ºF or 15
to 35ºC) prior to testing.
2. Insert a Test Strip, white side face up, Contact Bar’s end rst, into the
test port. The Meter will automatically turn on.
3. All segments of the LCD display will appear, a beep will sound and the
code number will appear followed by a ashing “ ” symbol. (Fig.9)
4. After the “ ” symbol appears, press the S button for 3 sec to switch con-
trol solution 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.(Fig.10)
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. (Fig.11)
6. Bring the tip of the Test Strip to lightly touch the drop of Control Solu-
tion. Control Solution is automatically pulled into the strip through the
tip. Hold until the meter beeps. The meter will now being counting down
from 5 to 1 and the Control Solution test result will appear. (Fig.12)
Easy Step
(Fig.9) (Fig.10)
Perform a control solution test
(Fig.11) (Fig.12)
15

Caution: Please remember that in order to prevent contamination, follow the above instructions for
performing the Control Solution test.
Comparing control solution results
The Easy Step is functioning properly if the result falls inside the specied range printed on the Test
Strip vial. If the test result falls outside the specied range, repeat the test.
Results falling outside the specied range may be caused by:
● Error in performing the test
● Control solution temperature is lower than 59°F(15°C) or higher than 95°F(35°C)
● Expired or contaminated Control Solution
● Expired or contaminated Test Strips
● Meter malfunction
If the problem persists, the system may not be working properly. DO NOT continue to use the system
to test your blood glucose level. If you continue to get results that fall outside the specied range,
please call Customer Service.
Note: The result testing in the Control Solution test “ctl“ mode will not be incorporated into the average
results function.
16
Caution: To reduce the chances of infection:
● Never share a lancing device and lancet with another person.
● Always use a new and sterile lancet. Lancets are for single use only.
● Always use a new Test Strip.
● Test Strips are for single use only.
● Do not get lotion, oil, dirt or debris in or on the lancet and lancing device.
1. Wash hands using soap and warm water. Rinse and dry thoroughly.
2. Pull out a Test Strip from the vial and re-cap the vial immediately.
3. Insert the Test Strip, white side face up, into the test port.
4. A beep will sound and the code number will appear followed by a
ashing “ ” symbol.
5. You can press and release M button to select the meal indicator for
marking the test as pre-meal or post-meal test. Indicator for meal:
Pre-meal and Post-meal
6. Now you are ready to obtain a blood sample.
Preparation for testing
17
Before testing blood glucose, you need the following items:
1. Easy Step Meter 2. Easy Step Test Strip 3. Lancing Device 4. Sterile Lancet
Testing Your Blood Glucose Level