PHSS Smartest Activa User manual

USER GUIDE
Blood Glucose Monitoring System
Activa

1. Contents
Section Topic Page
01. Table of Contents
02. Introduction
03. Appearance and Key Functions of the meter
04. Alternate Site Testing
05. Safety Information
06. Quick Testing Instructions
Preparing for Testing
07. Installing the Battery
08. Setting the Audio Voice Volume and Language
09. Settings (Date/Time/Alarm/Measuring Unit and
Memory Deletion ) and LCD Screen Introduction
10. Running a Control Solution Test
Blood Testing
11. Running a Blood Glucose Test
12. Recalling the Memory and Viewing the Average
13. Expected Values Reference
14. Transmitting Results
Maintenance
15. Maintenance of Your System
16. Troubleshooting
17. Customer Service
18. Limitations
Important Additional Information
19. Specifications
20. Ordering Supplies
21. Warranty Information
1
1
2-3
4
5-8
9
10-11
12
13-14
15-19
20-21
22-24
25-28
28
29
30
31-34
34
35
36
37
38
NOTE: For information about the name of the manufacturer of
the lancing device and the lancets, please refer to the package
inserts that came with your starter kits.

2
2. Introduction
Intended Use/ Indications for Use
The Smartest Activa Blood Glucose Monitoring System is intended
for use in the quantitative measurement of glucose in fresh capillary
whole blood from the finger and the forearm. It is intended for
use by healthcare professionals and people with diabetes mellitus
at home and as an aid in monitoring the effectiveness of a diabetes
control program. The Smartest Activa Blood Glucose Monitoring
System is not intended for the diagnosis of or screening for diabetes
mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be
used during steady-state blood glucose conditions.
“ contains a speaking function that provides audible
messages to assist the user; however, the system is not intended
for visually impaired users.”
Smartest Activa
Contents of the System
This User Guide has been prepared to describe the proper use of
the Smartest Activa Blood Glucose Monitoring System. Please read
this User Guide and the package insert that comes with the
Smartest Activa Glucose Test Strips before testing. The system is
available either as a meter alone or as a kit. If you have a meter only,
you can purchase the system supplies from your system provider.
Please provide to your system provider with the 3 digit system
reference number marked on the packaging box when you purchase
supplies.

3
The starter kit of the Smartest Activa Blood Glucose Monitoring System
includes the following items.
1. Smartest Activa Glucose Meter with 2 AAA batteries
2. User Guide
3. Log Book
4. Carrying Case
5. Smartest Activa Glucose Test Strips
6. Smartest Activa Control Solution (Medium)
7. Sterile Lancets
8. Lancing Device
9. Package Inserts for Test Strips, Control Solution, and Lancets
/ Lancing Device
“A single level control solution (Medium) is provided in the “Starter
Kit,” and no control solution is included in the “Meter Only” kit. You
may purchase any control solutions that you need from your system
provider.”
The Smartest Activa Glucose Meter uses Smartest Activa Test Strips.
Neither the meter nor the test strips will work when used with any
other brand of glucose products.

4
3. Appearance and Key functions
of the meter
(1)
(2)
(6)
The principle of the method
When glucose reacts with the reagents on the test strips, an electrical current
is produced, which is proportional to the glucose concentration in the blood sample.
The glucose concentration is calculated by the meter and based on the current measured.
(3)
(4)
(9)
(5)
(10)
(7)
(8) (11)
1.Test strip slot- When the strip is inserted into the
slot, the meter will automatically turn on.
2. LCD Display- Guide the user through the test using
symbols and simple messages.
3. M Key- Power ON/OFF, also for memory recalling
mode (please refer to manual for detailed function
description).
4. C Key- Confirm setting, view average of memory
and flag the test (please refer to manual for
detailed function description).
5. Speaker- Where voice comes out.
6. Up( ) Button- Increase the value of the current
setting and the voice volume.
7. Down(V) Button- Decrease the value of the
current setting and the voice volume.
8. Language Selection Button- Change between
audible languages(English or Spanish).
9. Mini-USB port- Connect cable between meter and
PC for data transmitting.
10. Battery Compartment- Where batteries are
located.
11. Ejector - Remove used strip.

4. Alternate Site Testing (AST)
What is AST?
Sampling from anatomical sites (parts of the body) other than
the fingertip (e.g., forearm, upper arm, thigh, calf, plam) to
check the blood glucose levels. This system allows you to test
on the forearm with the equivalent results to fingertip testing.
There are important limitations to AST. Please consult your
healthcare professional before you use AST.
What is the advantage ?
It is more painful feeling when taking blood sample from
fingertips because fingertips have many nerve endings. Other
body sites do not have as many nerve endings, so you will not
feel as much pain as at the fingertip.
When to use AST ?
Medication, stress, illness, food and exercise can affect blood
glucose levels. Capillary whole blood at the fingertip can reflect
test changes faster than capillary blood at other sites of body. If
you test your blood glucose level during or immediately after
a meal, physical exercise or stressful events, take the blood
sample from your fingertip instead of from other sites.
Use AST only:
1. 2 hours or more after taking isulin;
2. 2 hours or more after a meal;
3. 2 hours or more after exercise.
Do not use AST if you are pregnant, or if you are aware that
your glucose level is not as stable as usual, or if you think
you have hypoglycemia (low blood sugar) or hyperglycemia
(high blood sugar).
Do not use AST if you think your blood glucose is low and
if your AST results do not match the way you feel.
5

Testing Procedure for AST
1.Please unscrew the lancing device
by turning the end cap counter
clockwise. A clear cap will come
with the package of a meter kit or a
lancing device.
The clear cap on the lancing device
will make it easy for you to get a
drop of blood for AST.
2.Insert a new lancet firmly into the
lancet holder.
3.Twist off the protective top of the
lancet.
4.Close the end cap of the lancing
device and grasp the lancing device
as shown. Slide into locking position.
If necessary, please set the lancing
device for a deeper puncture.
5.Select a soft, fleshy area on your
forearm that is clean and dry, away
from bone and free of visible veins
and hair.
1
2
3
4
5
6

6.Massage the selected area gently
to increase blood flow to the
puncture site. Clean the test location
with an alcohol wipe or with soap
and water.
7.Open the test strip vial. Take one
test strip out of the vial and quickly
cover the vial to keep air out.
8.Insert a test strip into the meter
while the meter is off. The meter
will turn on with a blinking blood
drop icon appears on the LCD
screen, and you will hear: “Hello,
the meter is ready.” and “Apply
blood now.”
9.Press and hold the loaded lancing
device against the forearm for a few
seconds, then press and release the
button.
6
7
8
9
7

10
10. Wait for a few seconds until the
blood drop forms. Make sure you
have sufficient blood to fill the small
window of the test strip. For
individuals who experience
difficulty in getting sufficient blood
for a test, it may be helpful to rub the
puncture site a little longer before
using the lancing device.
11. Apply your blood to the front
edge (the tip) of the test strip, and
the meter will start counting down
for 6 seconds then display the test
results on the screen. You will hear:
“Testing in process.” and “The
glucose level is number/unit.”
12. Remove the used strip by hand
or by pressing the strip ejector.
The meter will turn off automatically.
You will hear: “Goodbye.” and the LCD
screen will display “ OFF”.
8
11
12

5. Safety Information
Please use this device only for the intended use described
in this user guide.
Before using this system to test your blood glucose,
please read instructions thoroughly and practice the test
when you first use this system. Do a quality check on
the system following the instructions and consult
with your healthcare professionals for questions or
problems.
Be aware of the safety of young children or handicapped
persons near you when you conduct a glucose test using
this system.
Smartest Activa test strips can only be used with the
Smartest Activa meter that has the same reference
number.
Please keep the test strip vial away from children. The
test strips and vial cap can present a choking hazard.
Please be cautious when removing the lancet. Take the
lancet out carefully. Always place the protective cap
back on the exposed tip or (if using a twist lancet)
place the cap on a hard surface and push the exposed tip
into the protective cap and discard of properly.
Please test your blood glucose using the meter and the
test strips with the same reference number as labeled on
the outer box of meter and the test strips.
Never try to disassemble the meter in any circumstance.
If your meter is not working properly, or if you need the
Technical Support, please contact your local distributor
for help.
9

6. Quick Testing Instructions
Figure 6-1
Figure 6-2
Figure 6-3
Figure 6-4
Figure 6-5
1.Wash hands with warm soapy
water and dry thoroughly.(Please see
Figure 6-1.)
2.Remove a test strip from vial and
recap vial tightly and immediately.
(Please see Figure 6-2.)
3.With meter off, insert a test strip
with the contacts up into the test strip
slot. The meter will turn on, and you
will hear: “Hello, the meter is ready.”
and “Apply blood now.”
(Please see Figure 6-3.)
4.Lance the finger and let a blood drop
form. (Please see Figure 6-4.)
5.If you wish to flag the glucose test
as a “Before-Meal” test, after you
hear: “Apply blood now.” press the
“C” button two (2) times. You will
then hear: “Ready for test before
meal.” If you wish to flag the glucose
test as an “After-Meal” test, after you
hear: “Apply blood now.” press the
“C” button three (3) times. You will
then hear: “Ready for test after meal.”
(Please see Figure 6-5.)
( For detailed instruction, start on page 20 for control
testing and page 22 for blood testing. This instruction
provides key steps for quick start.
Please read through all the detailed
instructions before real testing to
assure the effectiveness of testing. )
10

6.If you do not want to flag the test,
when you see a blinking blood drop
and hear: “Apply blood now.” please
apply blood to the front edge of the
test strip. Once sufficient blood is on
the test strip you will hear: “ Testing in
process.” (Please see Figure 6-6.)
7.After a 6 second countdown, the test
result will appear on the screen. You
will hear: “ The is
number/unit.” For those flagged
glucose tests, the screen will display
an “A” on the right side of the reading
as an After-Meal test and a “b” as a
Before-Meal test. (Please see Figure 6-7.)
8.Remove the test strip from the
meter and the meter will turn off
automatically. You will hear:
“Goodbye.”
(Please see Figure 6-8)
Notes:
Voice volume can be adjusted by the two
Up/Down toggle buttons below the LCD
screen of the meter.
To change the audible readout language
of the meter, press the round button inside
the battery cover of the meter two times.
(Please see Figure 6-9.)
glucose level
and the LCD screen will
display “ OFF.”
MemMem
:
1-01~0101
AM
:
1-01~0101
AM
MemMem
Figure 6-6
Figure 6-7
Figure 6-9
Figure 6-8
11

7. Installing the Battery
12
1. If the meter is on, turn the meter
off by pressing and holding the
“M” button for two seconds.
2. Open the battery cover on the
back of the meter by pushing the
arrow marked on the battery cover.
3. Remove the two used batteries
and replace with two (2) new 1.5V
AAA alkaline batteries. Put the
battery cover back and slide into
the battery cover slot. You will
hear a beep sound if the battery is
installed correctly.
(Please see Figure 7-1.)
(Please see Figure 7-2.)
(Please see Figure 7-3.)
Important:
1.It is suggested that you replace the batteries when battery
icon appears empty. You must replace the batteries when
E_3 error message is displayed on the screen.
2.Replacing the batteries will not delete the stored
testing results or any meter settings EXCEPT time and date.
You will need to reset the time and date after the batteries
have been replaced.
3.Please dispose of used batteries according to your local
ordinances.
Figure 7-1
Figure 7-3
Figure 7-2

8. Setting the Audio Voice Volume
and Language
13
With the meter off, the voice volume
of the meter can be adjusted by
pressing the “Up” or “Down”
button. The meter screen will display
the voice volume you set last time.
The volume range is divided into 7
levels from 0 to 7. If you set the voice
volume to “0”; you will hear: “Voice
off. ” The speaker icon will disappear
from the LCD screen.
If you press “Up” button from “ 0”
the voice volume will be adjusted
upward by one level each time you
press the “Up” button. You will
hear a beep sound to indicate the
current voice volume level.
(Please see Figure 8-2.)
(Please see Figure 8-3.)
Below the LCD screen of the meter,
you will find two buttons, the “^”
symbol and the “v” symbol. The “^”
symbol (“Up” button) indicates
increased volume and the “v” symbol
(“Down” button) indicates decreased
volume. (Please see Figure 8-1.) Figure 8-1
SETSET
SETSET
Figure 8-2
Figure 8-3
:
1-01~12 00
AM
:
1-01~12 00
AM

If you keep pressing the “Up” button
after setting 7, the LCD screen will
display “OFF” with an audible voice
saying “Goodbye”, and the meter will
turn off automatically. If you want to
adjust down the voice volume, press the
“Down” button. If you keep pressing
the “Down” button, you will hear:
“Voice off” at setting 0, and the meter
will turn off automatically. The LCD
screen will display “OFF” with a beeping sound.
The speaker icon will appear on the
LCD screen when the voice function
is turned on. The default setting for
talking meter is voice “ON”. If you do
not press any thing for 2 seconds, the
meter will say “Goodbye” and the LCD
screen will display “OFF”
Below the “Up” and “Down” buttons,
there is a round button which is for
language selection.
When meter is off, please press this
round button to toggle between English
and Spanish. The screen will show
“E” or “S” and you will hear “English”
or “Espanol” if the voice is on.
If you stop pressing this round button
for up to 2 seconds, the meter will
automatically turn off with an audible
voice saying, “Goodbye.”and the LCD
screen will display “OFF.”
(Please see
Figure 8-4.)
(Please see Figure 8-5.)
(Please
see Figure 8-6.)
:
1-01~12 00
AM
SETSET
Figure 8-4
SETSET
Figure 8-6
:
1-01~12 00
AM
14
Figure 8-5

9. Settings (Date/Time/Alarm/Measuring Unit
and Memory Deletion) and LCD Screen
Introduction
1.Appears with the test result either in mg/dL or in mmol/L.
2.Appears when you recall the memory.
3.Appears when you are in setting mode.
4.Appears as test flags. C for control solution test, b for blood test
before meal, A for blood test after meal,
no flag for blood test without flag.
5.Flashes when it is ready to apply the sample.
6.Indicates the battery status.
7.Indicates if audio function is on or off.
8.Indicates current displayed result is
an average.
9.Appears when alarm is on.
10.Month
11.Day
12.Hour
13.Minute
(1)Measurement Units
(6)Battery Symbol
(3)Setting
(2)Memory
(10)Month
(11)Day (12)Hour
(13)Minute
(4)A/b/C
(5)Blood drop icon
(7)Voice Symbol
(8)Day Average
(9)Alarm
Reminder
By pressing the “M” button and hold for 2 seconds,
you will enter the setting mode.
Then the “C” key alone will be used to toggle between
the different settings. The “Up/Down” toggle buttons
on the right hand side of the meter will be used to
increase or decrease the value of current setting.
The LCD screen will show as below:
Figure 9-A
The LCD screen for Power Off - When the meter is off, the date, time,
measurement unit, battery icon and “OFF” will be still on the screen ( Please
see Figure 9-A). If the voice is on or the alarm reminder is on, the speaker icon
and the alarm icon will be displayed as well.
15

1.With the meter off, press the “M”
key and hold for 2 seconds. The
LCD screen will display “ 09 ” as
the last two digits of current year.
The meter is now in the setting
mode. You will hear: “You are now
in setting mode.” and “Please set
the year.” (Please see Figure 9-1.)
2.Set the Year - Press the “Up” or
“Down” key on the right side of the
meter until the last two digits of the
desired year appears on the LCD
screen. Each time you adjust the
year, you will hear: “The year is xxx.”
if the voice is on. Press “C” key to
confirm and then the month segment
on the LCD will flash. You will hear:
“Please set the month.” (Please see
Figures 9-2, 9-3, 9-4, 9-5.)
3.Set the Month- Press the “Up” or
“Down” key on the right side of
the meter until the desired month
appears on the LCD screen. Each time
you adjust the month, you will hear:
“The month is xxx,” if the voice is
on. Press “C” key to confirm and
then the day segment on the LCD
screen will flash. You will hear:
“Please set the day.” (Please see
Figure 9-6.)
:
12-01~0101
AM
SETSET
:
1-01~01 01
AM
SETSET
Figure 9-2
Figure9-3
Figure 9-4
Figure 9-5
Figure 9-1
SETSET
AM
:
1-01~01 01
16

:
12-18~0101
AM
SETSET
:
12-18~1101
PM
SETSET
:25
12-18~11
PM
SETSET
(Please
see Figure 9-7.)
(Please
see Figure 9-8.)
7.Set the Alarm Reminder - Press the “Up” or “Down” key
to select the setting for the alarm reminder. You will see the
alarm icon is flashing with an “AL” display on the LCD
screen
4.Set the Day - Press the “Up” or
“Down” key on the right side until
the desired day appears on the LCD
screen. Each time you adjust the day,
you will hear: “The day is the xxx,”
if the voice is on. Press “C” key to
confirm and then the hour segment
on the LCD screen will flash. You will
hear: “Please set the hour.”
5.Set the Hour - Press the “Up” or
“Down” key on the right side until
the desired hour appears on the LCD
screen. Each time you adjust the hour,
you will hear: “The hour is xx am or
pm,” if the voice function is on.
Press “C” key to confirm and then
the minute segment on the LCD
screen will flash. You will hear:
“Please set the minute.”
6.Set the Minute - Press the “Up”
or “Down” key until the desired
minute appears on the LCD screen.
Each time you adjust the minute, you
will hear: “The minute is xxx,” if the
voice function is on. Press “ C” key
to confirm and then the alarm icon
will be displayed on the screen for alarm setting. You
will hear: “Please set alarm.”
and you will hear: “Set alarm reminder.” (Please see
Figure 9-9.) Press “C” key to confirm the setting, then you
:
03 40
AM
SETSET
Figure 9-6
Figure 9-9
Figure 9-7
Figure 9-8
17

will see the hour segment“00:00” flashing
on the screen. Press the “Up” or “Down”
key until the desired hour appears on the
screen and then press “C” key to confirm
the hour setting. Each time you adjust the
hour, you will hear: “The hour is xx am or
pm,” if the voice is on. Then the minute
segment “00:00” will be flashing on the screen.
Press the “Up” or “Down” key until the desired reminder minute
appears on the screen. Each time you adjust the minute, you will
hear: “The minute is xx.” Press “C” key to confirm the setting.
(Once the Alarm Reminder is set, the meter will beep for 60
seconds every day at the set Alarm Reminder time: you can press
C key to stop the beeping sound.) If you have set the alarm to 8:45
am, You will hear:“Alarm Reminder is set to 8:45 am.”
(Please see Figure 9-10.)
Figure 9-10
:
08 45
AM
SETSET
SETSET
SETSET
Figure 9-11
Figure 9-12
8.Set the measurement unit - Press
“Up” or “Down” to toggle between
the selection of “mg/dL” and “mmol
/L.” The LCD screen will display
either “mg/dL” or “mmol/L” when
pressing “Up” or “Down” key. Each
time you press “Up” or “Down”, you
will hear: “measurement unit in
milligrams per deciliter” or
“measurement unit in millimole per
liter ” if the voice is on. Press “C ” key
to confirm the measurement unit
selection. (Please see Figure 9-11, 9-12.)
Then the screen will show a flashing “dEL” and you will
hear: “Ready to delete memory records. Press the down
button to delete all records.” (Please see Figure 9-13.)
If you decide not to set the alarm after you first hear: “Please
set alarm,” press the “Up” or “Down” key until the alarm
icon disappear from the screen and the meter becomes silent.
Then press “C” key to exit the alarm setting. You will then
see a “mg/dL” or “mmol/L” is flashing on the upper left
corner of the LCD screen. And that means you are ready to
set the measurement unit.(Please see Figure 9-11.)
You will hear: “Please set the unit.”
18

9.Delete Memory- When you hear: “Ready
to delete memory records. Press the Down
button to delete all records.” You can press
“Down” button if you want to delete memory
records. You will hear: “Are you sure you
want to delete all records? Press the Down
button again to delete all records.” A “dEL”
and a small “Mem” will be flashing on the screen.
(Please see Figure 9-13.) Then press the “Down” button for
the second time to permanently delete all memory records,
or you can still press “C“ key to skip the
memory deletion when you hear: “Are you
sure you want to delete all records? ” The
meter will then automatically power off with
an audible voice “Goodbye.”
Warning: This meter can show results either in “mg/dL” or mmol/L
units. It is very important to use the correct unit of measurement to
properly manage your diabetes. If you live in U.S.A., you should
use mg/dL; your results will never have a decimal point. If you live
in Canada or some European countries, you should use mmol/L;
your result will always have a decimal point. The unit of
measurement -mg/dL- is the standard unit of measurement in the
U.S. If the meter is to be sold in the U.S., the units of measure
will be set to mg/dL by default.
Note:
1.When you change the date and time backward, you will not
change the test results in the meter memory.
2. You need to move through the year, month, day, hour, minutes,
alarm, measurement unit and dEL to save the meter settings
and turn off the meter.
Mem
Figure 9-13
SETSET
19
If you want to skip this memory deletion step, press the “C”
key when you first hear: “Ready to delete memory records.
Press the Down button to delete all records,” and the meter
will then automatically power off with an audible voice
“Goodbye”. The LCD screen will display “OFF.” (Please see
Figure 9-14.)
Figure 9-14