ISO
15197:2013
ISO
9001:2015
ISO
13485:2016
SC-GLSPL-0219A
IVD
Table of Contents
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 ........................................................
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
Error Message ..............................................................................................16
Troubleshooting ...........................................................................................17
Technical Specifications
Gluco Spark System Specifications ..........................................................18
Explanation of Symbols ..............................................................................19
Log book tables ......................................................................................... 20
System trouble shooting
9
.
Important information about your
Gluco Spark blood glucose monitoring system
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.
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.
Do use the Gluco Spark system for:
Testing blood glucose.
Testing only with fresh capillary whole blood samples.
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.
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
Gluco Spark ystem uses 0. sample. s 5 µL
So you can test on a variety of locations
Alternate Test Sites
Suggested Test
Areas for the Hand
The human figure above shows the areas where you can test with
the Gluco Spark System. Avoid moles, veins, bones, and tendons.
Warning:
We recommend that you test on your fingers for better results.
02
Upper arm
Forearm
Hand
Fingertips
Thigh
Calf
Gluco Spark meter and how it works
This screen always appears when the meter
is turned on so that you can make sure the
14:33 05-01-19
display is working properly. Do not use the
meter if the system check screen does not
match the example here.
(NO) Button
Exit
Strip Ejector
Press this button to
release the used
strip after testing.
Sample Area
Apply blood to
sample area at
end of the strip
only.
Carbon Electrode
(for accurate results)
Reference Electrode
Plasma Etching
(for excellent precision)
Fast Draw Technology
(fast and easy)
Sample Application Area
03
mg/dL
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(Yes) Button
Previous Readings.
Display Screen
Di spl ays yo ur t est
re su lt s a nd ot he r
important information.
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.
Sensa Core
®
Gluco Spark Meter Display
Blood Drop Symbol
This symbol works with
st ri p s ym bol in an
animation to tell you
when the meter is ready
to apply blood.
Test Result Area
Displays test results.
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Time and Date
Shows Time and Date
of the Test
Battery Symbol
Strip Symbol
This symbol works wi th
Blood Drop symbol in an
animation to indicate that
the meter is ready to apply
blood.
mg/dL (U.S. Standard)
Indicates unit of
measurement.
04
Gluco Spark test strip
Apply blood to strip sample area per test.
Important:
Test strips may be used only once. Discard used test strips.
You can continue to fill the test strip for up to 60 seconds.
Warning:
The cap or vial contains drying agents that may be harmful if inhaled or swallowed and
may cause skin or eye irritation.
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.
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.
Note:
For further information, refer to the Gluco Spark Test Strip package insert.
05
Test Strip
Sample Area
Testing your blood glucose
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mg/dL
Important:
To ensure accurate results, wash your hands and test site
(for example, your finger) with soap and water. Make sure
is no cream
there
your hands and test site.
With the Gluco Spark meter, you can test your blood glucose on your
forearm, fingers, upper arm, hand, thigh, or calf.
Testing w ith the Glu co Spark me ter requi res a very sm all sampl e size
0.5 µL of blo od; about t he size of pi nhead
Note
We recommend that you test on your fingers for better results.
or lotion on the test site. Thoroughly dry
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.
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.
Note:
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.
System check screen
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System Check
Blood Drop and
Test Strip Symbols
When the meter powers on, this screen will
appear so that you can make sure the
display is working properly.
The blood drop and test strip symbols will
appear on the display screen. Your meter is
now read y to ap ply blo od sa mple.
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
06
Obtain a blood sample
2
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 )
Note
We recommend that you test on your fingers for better results.
3 Filling the Gluco Spark test strip with blood
a.
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.
b.
Bring the Gluco Spark Test Strip to the blood
sample at a slight angle.
c.
The Gluco Spark Test Strip acts like a sponge
and pulls the blood into the strip through the
sample area.
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.
07
Waiting for result
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mg/dL
4
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 a ver ag e, yo ur r ead in g wil l disp lay i n
5 se con ds .
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
Instructions for use of Safety Lancets
How to use
1
2
3
11
LO and HI Readings
Important:
Low or high blood glucose readings can indicate a potentially serious
medical condition. The Gluco Spark Meter displays results from
20 to 800 mg/dL
LO Reading with Symptoms
If you have a reading below 70 mg/dL a nd have symptoms
such as w eakness, sweati ng, nervousness , he adache o r
confusi on, then fo llow your d octor's r ecommen dation to t reat
hypogly cemia.
HI Reading with Symptoms
If your test result is above 800 mg/dL, this indicates severe
hyperglycemia (high blood glucose).
If you feel symptoms such as fatigue, thirst, excess urination, or
blurry vision, then follow your doctor's recommendation to treat
hyperglycemia.
HI Reading without Symptoms
If you g et a HI read ing, b ut have no s ympt oms of hig h bloo d
gluc ose, th en re -test wi th a new t est str ip. I f you st ill g et a HI
read ing, follo w you r doc tor's reco mmendat ion t o tre at
hype rglyce mia.
12
Meter Maintenance
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.
Replacing the Battery
Open the battery cover as
shown in the image
Tilt the meter to sideways to
release the battery
13
Insert a new battery with
“+” symbol on the top
Close the battery cover
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.
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Setting the Time
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00: 00
: 02
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00
Note:
To quickly adjust a certain number, keep pressing the > button until the one you
1.
want appears.
2.
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.
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.
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.
The number in the hour position will now flash.
Press “>” (forward) button until you reach the
current hour.
Press “<” (backward) button to set.
14
Important Notes
Caring for your meter
Taking care of your meter is very simple. Just follow the guidelines shown below
1.
Do not disassemble your meter. If you have any questions, please contact
your local authorized distributor of Gluco Spark Blood Glucose Monitoring
System.
2.
Please use your meter carefully. Avoid throwing, shaking, or dropping it,
which may damage its internal parts.
3.
Clean the meter’s surface with a soft tissue slightly dampened with water.
Do not use alcohol or abrasive solutions.
4.
Do not wash or pour liquid on the meter.
Cleaning of your meter
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.
Important:
Never immerse the meter in water or any other liquid.
Handling & Storage
Handle your meter with care and protect it from direct sunlight or
1.
extremely high or low temperature.
Do not expose your meter and test strips to an environment of high
2.
humidity, such as in bathrooms, kitchens, etc.
Keep your meter free of dust.
3.
It is recommended that you use the carrying case that is designed to
4.
store and protect your Blood Glucose Monitoring System.
Put your system in an appropriate operating environment at least
5.
30 minutes before testing.
15
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.
Error Message Cause and Solution
• 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.
16
Troubleshooting
Meter does not enter the test mode after inserting a test strip.
Probable cause
The battery is dead. Replace the battery.
The battery is installed
incorrectly or there is no
battery in the meter.
Test strip inserted upside
down, wrong end in, or
incompletely inserted into
the meter.
Test does not start after applying the blood sample.
Probable cause
Blood sample too small.
Defective test strip.
Sample applied after meter
times out (one minute) and
turns off.
Sample applied before the
appearance of blood sign
What to do
Check that the battery is installed
correctly with the positive (+) sign
facing upward, towards you.
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
Replace the Strip and apply enough
Sample. Do not apply blood to the
strip with small Sample.
Repeat the test with a new
Gluco Spark test strip
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.
17
Technical Specifications
Gluco Spark system specifications
Test Principle
Assay Method
Automatic Shutoff
Hematocrit
Measurement Units
Strips Storage Temp.
Operating Temperature
Operating Relative Humidity
Memory
Power Source
Battery Life
Result Range
Sample
Sample Size
Meter Size (Centimeters)
Display Size (Millimeters)
Test Time
Weight
Strip Ejection
Construction
Protection Class
Determination of glucose in fresh
capillary whole blood
Amperometric Bio sensor
After 5 seconds, depending on
operating status
15 % to 65 %
mg/dL
0 0
0 to 50 C (Do not refrigerate)
0 0
2 to 50 C
10 % to 95 % (non-condensing)
500 Previous Readings
One 3 volt lithium battery (CR2032),
replaceable
Approximatly 1000 tests
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
Handheld
B
18
Blood
OTHER NOTES
Glucose
Insulin/
Medication
Blood
Glucose
Insulin/
Medication
Blood
Glucose
Insulin/
Medication
Blood
Glucose
Insulin/
Target Range for Blood Sugar set with your Healthcare Professional
Wakeup Time _____________ Before Meals _____________ After Meals _____________ At Bed Time _____________
BREAKFAST LUNCH DINNER BEDTIME
Blood
Date
Medication
Glucose
M
T
W
20
F
T
S
S
Avg.
Blood
OTHER NOTES
Glucose
Insulin/
Medication
Blood
Glucose
Insulin/
Medication
Blood
Glucose
Insulin/
Medication
Blood
Glucose
Insulin/
Target Range for Blood Sugar set with your Healthcare Professional
Wakeup Time _____________ Before Meals _____________ After Meals _____________ At Bed Time _____________
BREAKFAST LUNCH DINNER BEDTIME
Blood
Date
Medication
Glucose
M
T
W
21
F
T
S
S
Avg.
SENSA CORE
Medical Instrumentation Pvt. Ltd.
Plot No: 3, Export Promation Industrial Pack, Pashamylaram,
Sangareddy (Dist.), Hyderabad - 502307, Telangana, INDIA.
Tel: +08455 - 223400, www.sensacore.com
Customer Care Number
1800 200 2880
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