Lacto Spark
Virtually
Painless
Lactate Measuring System
Lacto Spark
USER MANUAL
1
Symbols:
The following are symbols which are featured on the packaging of the meter.
They are explained as follows:
In vitro diagnostic medical device
Fulfills requirements of Directive 98/79 EC (IVDD)
Caution, consult accompanying documents
Consult instructions for use
Biological risk
Catalog number
Temperature limitation
Manufactured by
About this Manual
This manual is for the Lacto Spark Meter. Throughout this manual, NOTE:
indicates especially important information, CAUTION: indicates information that
is critical to avoid instrument damage or incorrect results, and WARNING:
indicates possible hazard to the operator.
2
Table of Contents
1. Important information about your
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3
Lacto Spark Blood Lactate Monitoring System Intended Use
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3
Test Site
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3
2. Lacto Spark meter and how it works
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4
Lacto Spark Meter Display
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5
Lacto Spark test strip
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6
3. Preparing to test your Blood Lactate:
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7
Lancing device handling procedure
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7
Performing a blood Lactate test
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9
Applying blood to Lacto Spark test strip
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10
Strip Ejection
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11
Ejection of used lancet
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12
4. Testing Control Solutions
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13
5. Lactate ranges in human blood
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14
6. Meter Maintenance
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15
Replacing the Battery
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7. Caring for your meter
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16
System Troubleshooting
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16
8. Troubleshooting
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9. Specifications
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1. Important information about your
Lacto Spark Blood Lactate Monitoring System Intended Use
The Lacto Spark Meter System is intended for by health-care professionals to
quantitatively measure lactate in whole blood to evaluate physical performance
and/or to establish a proper intensity of exercise for athletes. The device system is
for in-vitro diagnostic use only.
Note:
The Lacto Spark meter should only be used with Lacto Spark test strips. Using
other test strips with the meter can produce inaccurate results.
Do use the Lacto Spark system for:
Testing blood lactate.
Testing only with fresh capillary whole blood samples.
Warning:
The Lacto 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 Lacto Spark system. Blood Lactate monitoring
should be done with the guidance of a health care professional.
Test Site
You can test only on fingers.
Lacto Spark System uses 0.5µL sample
From the above figure shows the area where you can test with the Lacto Spark
system.
Finger Tips
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2. Lacto Spark meter and how it works
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.
(Yes) Button
Previous Reading
(NO) Button
Exit
Test Strip Part
Insert the top end of a new Lacto
Spark Test Strip here. The meter
powers on when you insert the test
strip.
Strip Ejector
Press this button to
release the used strip
after testing.
Display Screen
Display your test
results and other
important information
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Lacto Spark Meter Display
Blood Drop Symbol
The symbol in an animation to
tell you when the meter is
ready to apply blood
Battery Symbol
Strip Symbol
This symbol works with Blood
Drop symbol in an animation to
indicate that the meter is ready to
apply blood
Display
Displays test results, saved
results and messages
mmol/L
Indicate unit of measurement
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Lacto Spark test strip
Apply blood to strip in sample area per test
With the Lacto Spark meter, you can test your blood Lactate on your fingers.
Testing with the Lacto Spark meter requires a very small sample size 0.5 µL of
blood; about the size of pinhead
Note:
Test strips should be used only once.
The Lacto Spark Meter should only be used with Lacto Spark Test Strips.
Using other test strips with this meter can produce inaccurate results.
Warning:
The vial contains drying agents that may be harmful if inhaled or swallowed and
may cause skin or eye irritation.
Important Test Strip Information
The Lacto Spark system has an operating range of 10oC to 40oC.
Store the test strip package in a cool, dry place between 10oC and 30oC.
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 Lacto 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 cot, or other Lacto Spark test strips.
Note:
For further information, refer to the Lacto Spark Test Strip package insert.
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3. Preparing to test your blood Lactate:
Check the following items are present in the package to carry out your lactate test:
Your Lacto Spark Meter with battery
The Lacto Spark test strips
A Lancing Device to obtain blood using Lancets
Note: Read the insert sheet which has come with the package before starting
the test.
Note:
To ensure accurate results, wash your hands
thoroughly with soap and water. Make sure
there is no cream or lotion on the test site.
Dry your hands and test site thoroughly. This
reduces the contamination of puncture site
and stimulates the blood flow.
Prepare your Lancing device to obtain blood (follow steps as per lancing device
handling procedure)
Lancing device handling procedure
Plunger
Lancet Holder
Ejector
Release Button
Arrow
Adjustable Tip
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Instructions for use
Step 1: Remove the lancing device cap
Remove the cap by turning it
counterclockwise and then pulling it straight
off of the device.
Step 2: Insert a sterile lancet into the lancing
device
Position the lancet as shown in picture, so
that the lancet fits into the lancet holder.
Push the lancet into the device until it snaps
into place and is fully seated in the holder.
Remove the protective layer cover of lancet
Step 3: Replace the lancing device cap
Place the cap back onto the device; turn
clockwise to secure the cap.
Step 4: Adjust the depth setting
This lancing device has 9 puncture depth
settings. Set the lancing device level 1 or 2 for
normal skin thickness, 3 or 4 for thick skin
and so on.
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Step 5:
Pull the Plunger of lancing device until it
clicks. If it does not click, it may already have
been pulled when you inserted the lancet.
Note: Leave the Plunger after clicking
Step 6 : Puncture your finger
Hold the lancing device firmly on your finger.
Press the release button. Remove the lancing
device from your finger.
Step 7 : Obtain Blood sample
Gently squeeze and/or massage your
fingertip until a drop of blood forms on your
fingertip. Apply the blood sample on the strip
connected to meter.
Performing a blood Lactate test
Insert test strip to turn On the Meter
Insert and slide a Lacto Spark test Strip into
the meter till the end. The meter turns ON and
a default display appears for 2 seconds.
System check screen
Check the segments of the display properly, if
u find any segment missing please contact the
service person.
Note: If you do not start the test within one minute (60 Seconds), the meter will
turn off. To restart the meter, take out the unused Lacto Spark test Strip and
reinsert it into the meter.
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Applying blood to Lacto Spark test strip
Flashing Blood Symbol on the meter
A test strip symbol and a flashing blood drop
symbol appears on the screen. You are now
ready to apply the blood sample.
Lance your fingertip
Lance your fingertip to obtain blood using
Lancing device.
Bring the Lacto Spark Test Strip to the blood
sample at a slight angle.
Note: Gently squeeze or massage your finger tip to obtain a drop of blood
Apply Blood Sample on the strip
The Lacto Spark Test Strip acts like a sponge
and draws the blood into the strip through the
sample area. When the meter detects the blood
you can hear a beep sound.
Read your result on the meter
Displayed result on Screen
The test will be finished in 5 seconds (displays
on the screen). Your Blood Lactate results
appears on the display.
Your results are saved automatically in the
meter
Note:
This meter has an ejection feature, you may not pull the strip with your hand.
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Strip Ejection
Ejection of used Strip
After getting the result, Press the strip ejector
button near to a dustbin so that the used strip
gets released from the meter and falls in the
dustbin.
The meter turns itself off.
Notes on testing Lactate
Do not pull the Lacto Spark test strip away until you hear beep sound or see
the timer starting on your meter screen. This results that the meter has taken
the sufficient sample and testing your lactate.
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 new
strip.
The test result is complete when your blood lactate test result is shown on the
display screen and you hear beep sound twice.
On average, your reading will display in 5 seconds.
Do not press the Lacto Spark test strip against the test site.
Do not scrape the blood onto the Lacto Spark test strip.
Do not apply blood to the top side of the Lacto Spark test strip.
Do not apply blood to the Lacto Spark test strip when the test strip is out of the
meter.
Do not put blood or foreign objects into the Lacto Spark test strip port.
Do not eject the test strip while test is in progress.
Only apply blood to the test strip when drop symbol is flashing on the display.
Use test strip only which are in use by date.
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Ejection of used lancet
Note: this lancing device has an ejection feature, so you do not have to pull out the
used lancet.
Remove the lancing device cap
Remove the cap by turning it
counterclockwise and then pulling it straight
off of the device.
Cover the exposed lancet tip
Before removing the lancet, place the lancet
protective cover on a surface then push the
lancet tip into the cover.
Eject the lancet
Slide the ejection control forward until the
lancet comes out of the lancing device.
Replace the lancing device cap
Place the cap back onto the device; turn
clockwise to secure the cap.
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Note:
It is important to use a new lancet each time you obtain a blood sample. This will
help to prevent from infections. Discard the used lancet carefully after each use to
avoid unintended lancet stick injuries. Used lancets may be considered
biohazardous waste in your area. Be sure to follow your healthcare professional’s
recommendations or local regulations for proper disposal.
4. Testing Control Solutions
NOTE: Before running a blood or control test, check that the expiry date of the
strips and control solution has not elapsed. (See product insert sheets for details.)
the control solution test results should fall within the range of results printed on
the label of the control solution. You should run a control solution test:
Before using your Lacto Spark Meter for the first time and at least once a week
thereafter.
Each time you open a new box of Lacto Meter Test Strips
If you leave the Lacto Spark Test Strip vial cap open for an extended period of
time
If you drop your Lacto Spark Meter
If your results are higher or lower than expected
User should follow the appropriate Indian, State Guide Lines concerning the
running quality controls.
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Testing Control Solutions:
1. Grasp a test strip, then insert the Electrode end into the meter.
2. Shake the control solution well before each use. Discard the first drop.
3. Place a drop of control solution from the bottle at the end of the test strip until
the solution is drawn into the well of the test strip.
NOTE:The on-screen Control Drop flashes on and off repeatedly until sufficient
control solution has been added to the test strip.
Warning:
Blood samples and blood products are potential sources of hepatitis and other
infectious agents. Handle all blood products with care. Wear gloves when
performing measurements on another person. Items that are used to measure
lactate, I.e., test strips, lancets, and alcohol swabs, must be disposed off in
accordance to local regulations to avoid risk to anyone.
5. Lactate ranges in human blood
The Lacto Spark Meter displays results from 0.2 to 25.0 mmol/L.
15
6. Meter Maintenance
Battery
Your Lacto Spark meter comes with one preinstalled, 3 volt, lithium battery
CR2032. 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 compartment Cover
Open the battery cover by pulling the locking
catch upwards and remove the battery
compartment cover as shown in the image.
Battery removal
Remove the battery by tilting the meter to
sideways.
Replacing the battery
Place new battery in battery compartment
with ‘+’ symbol facing upwards.
Close the battery Compartment Cover
Place the battery compartment cover back on
again. The two prongs on the lower edge must
engage with the slots in the battery
compartment.
Close the battery cover by pressing the
battery compartment cover closed. It will
CLICK intoplace audibly.
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7. Caring for 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.
The meter should be handled with care. Dropping, rough handling, etc. may
damage the meter. Also, protect the meter from moisture, prolonged direct
sunlight, and high temperatures.
System Troubleshooting
Error messages
Possible Causes
Incorrect test procedure. For
example, putting Blood on the test
strip before inserting the test Strip
into the meter or applying blood
before the blood drop and test strip
symbols display.
Problem with the Lacto Spark test
strip.
Problem with the meter.
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8. Troubleshooting
What you should do
Be sure you see the blood drop and test strip symbols on the display screen before
you apply blood.
Meter does not enter the test mode after inserting a test strip.
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 upwards i.e., towards you.
Test strip inserted upside down, wrong
end in, or incompletely inserted into
the meter.
Insert the Lacto Spark Test Strip. Place
the end of the strip with the two
contact bars as far into the meter as it
can go.
Test does not start after applying the blood sample.
Probable cause
What to do
Blood sample too small.
Replace the Strip and apply enough
Sample. Do not apply blood to the strip
with small Sample.
Defective test strip.
Repeat the test with a new Lacto Spark
test strip.
Sample applied after meter times out
(one minute) and turns off.
Repeat the test using a new test strip.
Wait until you see the Blood drop and
Test Strip symbols on the display
screen before you apply the blood
sample.
Sample applied before the appearance
of blood sign
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9. Specifications
Assay Method
Amperometric Biosensor
Automatic Shutoff
5 seconds
Battery Life
1000 tests
Hematocrit
15 % to 65 %
Measurement Units
mmol/L
Strips Storage Temp.
10oC to 30oC
Memory
Previous Readings
Operating Relative Humidity
5 % to 90 % (non-condensing)
Operating Temperature
10oC to 40oC
Power Source
One CR 2032, 3 volt, lithium battery,
replaceable
Result Range
0.2 to 25.0 mmol/L
Sample
Capillary Whole blood
Sample Size
0.5 μL (500 nanoliters)
Meter Size (Centimeters)
Length 10.0 x Width 3.1 x Depth 1.4
Display Size (Millimeters)
48 (diagonally)
Test Time
Average of 5 seconds
Weight
34 grams
Strip Ejection
Yes
SE N SA COR E M EDIC A L INSTR U MENT A TION PV T . LTD.
Plot No: 3, EPIP Zone, Pashamylaram, Sangareddy Dist.,
Hyderabad, Telangana, INDIA. - 502307,
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