Sensa Core Gluco Spark User manual

ISO
15197:2013
ISO
9001:2015
ISO
13485:2016
IVD
SC-GLSPL-0219A

Important Information About Your
Gluco Spark Blood Glucose Monitoring System ....................................... 1
Alternate Test Site.......................................................................................... 2
Gluco Spark Meter and How It Works.........................................................3
Gluco Spark Meter Display........................................................................... 4
Gluco Spark Test Strip ...................................................................................5
Testing Your Blood Glucose
Testing Your Blood Glucose.... .................................................................... 6
1. Performing a Blood Glucose Test ........................................................... 6
2. Filling the Gluco Spark test strip with blood ...........................................7
3. Waiting for result ....................................................................................... 8
Strip Ejection
Strip Ejection .................................................................................................. 8
Lancing device handling procedure
Lancing device handling procedure ........................................................9
.
Obtaining a blood sample .......................................................................10
Safety Lancets handling Procedure ........................................................11
Low and Hi Readings
Low & High Readings .................................................................................12
Meter Maintenance
Replacing the battery ...............................................................................13
Time and Date set-up ................................................................................14
Important Notes
Caring & Cleaning for your meter ............................................................15
Handling & Storage ....................................................................................15
System trouble shooting
Error Message ..............................................................................................16
Troubleshooting ...........................................................................................17
Technical Specifications
Gluco Spark System Specifications ..........................................................18
Explanation of Symbols ..............................................................................19
Log book tables ......................................................................................... 20
Table of Contents

Important information about your
Gluco Spark blood glucose monitoring system
Important:
The Gluco Spark meter should only be used with Gluco Spark test strips. Using other
test strips with this meter can produce inaccurate results.
Warning:
The Gluco Spark system contains small parts that may be dangerous if swallowed.
Caution:
Please read all the instructions provided in this owner 's booklet and practice the
testing procedures before using the Gluco Spark system. Blood glucose monitoring
should be done with the guidance of a healthcare professional.
The Gluco Spark system is intended for use outside the body (in other
words, in vitro diagnostic use only).
The Gluco Spark system is used for measuring blood glucose (also known
as blood sugar) from samples taken from the forearm, upper arm, hand,
thigh, calf or fingers.
Do use the Gluco Spark system for:
Testing blood glucose.
Testing only with fresh capillary whole blood samples.
Important health-related information
Severe dehydration and excessive water loss may cause false low results.
If you believe you are suffering from severe dehydration, consult your
physician or doctor immediately.
Test results below 70 mg/dL mean low blood glucose (hypoglycemia).
Test results greater than 180 mg/dL mean high blood glucose
(hyperglycemia).
If you get results below 70 mg/dL or above 180 mg/dL and do not have
symptoms of hypoglycemia or hyperglycemia, repeat the test. If you
have symptoms or continue to get results that fall below 70 mg/dL or
above 180 mg/dL, follow the treatment/advice of your healthcare
professional.
If you are experiencing symptoms that are not consistent with your blood
glucose test and you have followed all instructions described in the
Gluco Spark owner's booklet, consult your healthcare professional.
01

Upper arm
Forearm
Hand
Fingertips
Thigh
Calf
Warning:
We recommend that you test on your fingers for better results.
The human figure above shows the areas where you can test with
the Gluco Spark System. Avoid moles, veins, bones, and tendons.
Suggested Test
Areas for the Hand
Alternate Test Sites
Gluco Spark ystem uses 0. sample. s 5 µL
So you can test on a variety of locations
02

Test Strip Port
Insert the top end of
a new Gluco Spark test
strip here. The meter
powers on when you
insert the test strip.
This screen always appears when the meter
is turned on so that you can make sure the
display is working properly. Do not use the
meter if the system check screen does not
match the example here.
Gluco Spark meter and how it works
Displa ys your test
resul t s a n d o t h er
important information.
Display Screen
Previous Readings.
Strip Ejector
Press this button to
release the used
strip after testing.
Apply blood to
sample area at
end of the strip
only.
Exit
(NO) Button (Yes) Button
03
Carbon Electrode
(for accurate results)
Plasma Etching
(for excellent precision)
Fast Draw Technology
(fast and easy)
Reference Electrode
Sample Application Area
Sample Area
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mg/dL
14:33 05-01-19

14:33 05-01-19
®
Sensa Core
Gluco Spark Meter Display
04
mg/dL (U.S. Standard)
Indicates unit of
measurement.
Blood Drop Symbol
Strip Symbol
Test Result Area
Displays test results.
Battery Symbol
This symbol works with
s t r i p sy m bo l in a n
animation to tell you
when the meter is ready
to apply blood.
This symbol works with
Blood Drop symbol in an
animation to indicate that
the meter is ready to apply
blood.
Time and Date
Shows Time and Date
of the Test

Test Strip
Sample Area
Test strips may be used only once. Discard used test strips.
You can continue to fill the test strip for up to 60 seconds.
Important:
The cap or vial contains drying agents that may be harmful if inhaled or swallowed and
may cause skin or eye irritation.
Warning:
Important:
The Gluco Spark Meter should only be used with Gluco Spark Test Strips. Using other test
strips with this meter can produce inaccurate results.
Note:
For further information, refer to the Gluco Spark Test Strip package insert.
Apply blood to strip sample area per test.
Important Test Strip Information
The Gluco Spark system has an operating range of 2° to 50°C.
Store the test strip package in a cool, dry place between 0° to 50°C.
Use test strips only within the system operating temperature range.
Keep away from direct sunlight and heat.
Store your test strips in their original vial only; never transfer them to
another vial or any other container.
Never store individual test strips outside the vial.
After removing a Gluco Spark test strip from the vial, immediately close
the vial cap tightly.
With clean, dry hands, you may touch the test strip anywhere when
removing it from the vial or inserting it into the meter.
Do not use test strips beyond the expiration date. This may cause
inaccurate results.
Do not bend, cut, or alter Gluco Spark test strips.
Gluco Spark test strip
05

Testing your blood glucose
Important:
To ensure accurate results, wash your hands and test site
(for example, your finger) with soap and water. Make sure
there
is no cream or lotion on the test site. Thoroughly dry
your hands and test site.
14:33 05-01-19
mg/dL
Blood Drop and
Test Strip Symbols
1 Performing a blood glucose test
Prepare your meter
Insert a Gluco Spark Test Strip into the meter
till it allows. The meter will power on.
If you do not start the test within one minute, the meter will turn off. To restart
the meter, take out the unused Gluco Spark test strip and reinsert it into the
meter.
Note:
When the meter powers on, this screen will
appear so that you can make sure the
display is working properly.
System check screen
The blood drop and test strip symbols will
appear on the display screen. Your meter is
now ready to apply blood sample.
System Check
With the Gluco Spark meter, you can test your blood glucose on your
forearm, fingers, upper arm, hand, thigh, or calf.
Testing with the Gluco Spark meter requires a very small sample size
0.5 µL of blood; about the size of pinhead
Times when you may be checking for low blood glucose include:
When you are feeling symptoms such as weakness, sweating,
nervousness, headache, or confusion.
When you have delayed a meal after taking insulin.
When your healthcare professional advises you to do so.
Important:
The Gluco Spark meter should only be used with Gluco Spark test strips.
using other test strips with this meter can produce inaccurate results
Note
We recommend that you test on your fingers for better results.
06
14:33 05-01-19

The Gluco Spark Test Strip acts like a sponge
and pulls the blood into the strip through the
sample area.
Select a test site. There are differences in testing on fingers versus other
alternative sites. Use your lancing device to obtain a blood sample.
Refer to the detailed instructions on how to use the Gluco Spark
lancing device. ( Page 9 to 11 )
Obtain a blood sample
2
3 Filling the Gluco Spark test strip with blood
Bring the Gluco Spark Test Strip to the blood
sample at a slight angle.
Do not press the Gluco Spark test strip against the test site.
Do not scrape the blood onto the Gluco Spark test strip.
Do not apply blood to the top side of the Gluco Spark test strip.
Do not apply blood to the Gluco Spark test strip when the Gluco Spark
test strip is out of the meter.
Do not put blood or foreign objects into the Gluco Spark test strip port.
Note
We recommend that you test on your fingers for better results.
Make sure that the Gluco Spark Test Strip is i n
the meter and the meter is powered on.
(If the meter is off, take out the test strip and
reinsert it into the meter.) You are now ready
to apply the blood sample.
a.
b.
c.
07

Waiting for result
4
14:33 05-01-19
mg/dL
Strip Ejection
Do not pull the Gluco Spark test strip away
until you hear one beep or see the timer
starting on your meter screen. this means
you have enough blood and the meter is
reading your glucose.
If after five seconds your meter does not
show a timer starting on the display screen,
the sample may be too small or strip might
be faulty. Replace the strip.
The test result is complete when your blood
glucose test result is shown on the display
screen and you will hear two beeps.
On ave rage, you r reading will display in
5 seco nds.
After getting the result, Press the strip
ejector button near a dustbin so that the
used strip gets released from the meter
and falls in the dustbin.
08

11
Instructions for use of Safety Lancets
How to use
1
2
3

LO Reading with Symptoms
LO and HI Readings
Low or high blood glucose readings can indicate a potentially serious
medical condition. The Gluco Spark Meter displays results from
Important:
If your test result is above 800 mg/dL, this indicates severe
hyperglycemia (high blood glucose).
If you have a reading below 70 mg/dL and have symptoms
such as weakness, sweating, nervousness, headache or
confusion, then follow your doctor's recommendation to treat
hypoglycemia.
HI Reading with Symptoms
If you get a HI reading, but have no symptoms of high blood
glucose, then re-test with a new test strip. If you still get a HI
reading, follow your doctor's recommendation to treat
hyperglycemia.
HI Reading without Symptoms
20 to 800 mg/dL
If you feel symptoms such as fatigue, thirst, excess urination, or
blurry vision, then follow your doctor's recommendation to treat
hyperglycemia.
12

Meter Maintenance
Replacing the Battery
Open the battery cover as
shown in the image
Battery
Your Gluco Spark meter comes with one preinstalled, 3 volt, lithium
battery. The battery provides enough power for the meter to perform
about 1000 Tests. If your battery runs low, the battery needs to be
replaced.
Tilt the meter to sideways to
release the battery
Insert a new battery with
“+” symbol on the top
Close the battery cover
13

Date and Time Set-Up (On Replacement of Battery)
Your Gluco Spark meter allows you to set the Date and Time as you like.
You can view 24 hour time.
To get into set-up mode, remove the battery and replace it. A complete
display will briefly appear, then numbers will flash in the bottom left corner
of the display.
Steps to set the Year, Date :
Remove battery and replace it to set date and time.
With the number flashing in the position of Year
on the display. Press “>” (forward) button until
you reach the current year.
Press “<” (backward) button to set.
14:33 05-01-19
The number in the month flashes on the display.
Press “>” (forward) button until you reach the
current month.
Press “<” (backward) button to set.
The number in the day position flashes on the
display. Press “>” (forward) button until you
reach the current day.
Press “<” (backward) button to set.
The minute will now flash. Press “>” (forward)
button to select the current minute.
Press “<” (backward) button to set.
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14:33 05-01-19
Setting the Time
00: 00 05-01-19
The number in the hour position will now flash.
Press “>” (forward) button until you reach the
current hour.
Press “<” (backward) button to set.
00: 02 05-01-19
To quickly adjust a certain number, keep pressing the > button until the one you
want appears.
Note:
At any steps if you want to shut the meter off, Press< button until you complete
the cycle and all setting still cab be automatically saved.
1.
2.
14

Avoid getting dirt, dust, blood, water, or any other liquid in the meter's test
strip and data ports. Clean the outside of the meter using a cloth
dampened with one of the following:
Mild detergent/mild soap and water.
70% isopropyl alcohol.
A mix of one part household bleach, nine parts water.
15
Cleaning of your meter
Caring for your meter
Taking care of your meter is very simple. Just follow the guidelines shown below
Do not disassemble your meter. If you have any questions, please contact
your local authorized distributor of Gluco Spark Blood Glucose Monitoring
System.
Please use your meter carefully. Avoid throwing, shaking, or dropping it,
which may damage its internal parts.
Clean the meter’s surface with a soft tissue slightly dampened with water.
Do not use alcohol or abrasive solutions.
Do not wash or pour liquid on the meter.
Important Notes
1.
2.
3.
4.
Never immerse the meter in water or any other liquid.
Important:
Handling & Storage
Handle your meter with care and protect it from direct sunlight or
extremely high or low temperature.
Do not expose your meter and test strips to an environment of high
humidity, such as in bathrooms, kitchens, etc.
Keep your meter free of dust.
It is recommended that you use the carrying case that is designed to
store and protect your Blood Glucose Monitoring System.
Put your system in an appropriate operating environment at least
30 minutes before testing.
1.
2.
3.
4.
5.

System troubleshooting
Error messages
When an error occurs, an error message appears
on the display with continuous beep sound. Turn
the meter off by ejecting the strip.
If your meter has been dropped, this can also lead to error messages.
If error messages occur frequently, contact your customer support and
service centre.
• You slid a used test strip into the meter.
• You applied blood or control solution to
the test strip too soon, i.e. before the
drop symbol flashed on the display.
Start the blood glucose test from the
beginning with a new test strip.
When strip is ejected from the meter
after applying the blood sample
Start the blood glucose test from the
beginning with a new test strip and wait
until the result appears on the screen.
Error Message Cause and Solution
16

Troubleshooting
Meter does not enter the test mode after inserting a test strip.
Test does not start after applying the blood sample.
Sample applied before the
appearance of blood sign
Repeat the test using a new test strip.
Wait until you see the Blood and Test
Strip symbols on the display screen
before you apply the blood sample.
Replace the Strip and apply enough
Sample. Do not apply blood to the
strip with small Sample.
Blood sample too small.
Probable cause
Probable cause
What to do
The battery is dead. Replace the battery.
The battery is installed
incorrectly or there is no
battery in the meter.
Check that the battery is installed
correctly with the positive (+) sign
facing upward, towards you.
Test strip inserted upside
down, wrong end in, or
incompletely inserted into
the meter.
Insert the Gluco Spark Test Strip
with the white sheet with sample
inlet side up and the top of the
strip in the meter.
What to do
Defective test strip. Repeat the test with a new
Gluco Spark test strip
Sample applied after meter
times out (one minute) and
turns off.
17

Assay Method
Automatic Shutoff
Amperometric Bio sensor
After 5 seconds, depending on
operating status
Battery Life Approximatly 1000 tests
Result Range
Sample
Sample Size
Meter Size (Centimeters)
Display Size (Millimeters)
Test Time
Weight
Strip Ejection
Construction
Protection Class
Hematocrit
Measurement Units
Strips Storage Temp.
Memory
15 % to 65 %
mg/dL
0 0
0 to 50 C (Do not refrigerate)
500 Previous Readings
Operating Relative Humidity
Operating Temperature
Power Source
10 % to 95 % (non-condensing)
0 0
2 to 50 C
One 3 volt lithium battery (CR2032),
replaceable
20 to 800 mg/dL
Capillary whole blood
0.5 µL (500 nanoliters)
Length 10.0 x Width 3.1 x Depth 1.4
48 (diagonally) LCD
5 seconds
34 grams
Yes
B
Test Principle
Determination of glucose in fresh
capillary whole blood
Handheld
18
Gluco Spark system specifications
Technical Specifications