HAIDEN Control D User manual

HAIDEN
Control D
Blood Glucose Monitoring System
User Manual
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Important Information
Control D Blood Glucose Monitoring System ............................................
Important Health-Related Information ......................................................
Alternate Test Site.........................................................................................
Control D Glucometer and Blood Glucose Test Strips
Control D Glucometer and How It Works...................................................
Control D Glucometer Display.....................................................................
Control D Blood Glucose Test Strips ...........................................................
Testing Your Blood Glucose
Preparng to Testing Your Blood Glucose.... ..............................................
Performing a Blood Glucose Test ...............................................................
Obtain a blood sample ...............................................................................
Applying blood to the Control D Blood Glucose Test Strips ...................
Strip Ejection
Strip Ejection .................................................................................................
Table of Contents
1.
2.
3.
4.
1
1
2
3
4
5
6
6
7
7
8
Lancing device handling procedure
Lancing device handling procedure ........................................................
Low and Hi Readings
Low Readings .......................................................................................... ....
Hi Readings ..................................................................................................
Meter Maintenance
Replacing the battery ...............................................................................
Technical Specifications
Technical Specifications ............................................................................
Explanation of Symbols ..............................................................................
Log book tables ..........................................................................................
5.
6.
7.
8.
9
12
12
13
Caring for your meter .................................................................................
System Troubleshooting ............................................................................
Troubleshooting ...........................................................................................
14
14
15
16
17
19

1. Important information
Control D (Blood Glucose Monitoring System)
The Control D Blood Glucose Monitoring System is intended use
to determine the quantitative measurement of glucose in whole
blood. The device is for shelf testing in vitro diagnostic use only.
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
Control D owner's booklet, consult your healthcare professional.
01
The Control D Blood Glucose Monitoring System is used for measuring
blood glucose (also known as blood sugar) from the samples taken from
the fore arm, upper arm, hand, thigh, calf or fingers.
Note : The Control D Glucometer should only be used with Control D Blood Glucose
test strips. Using other test strips with this meter can produce inaccurate results.
Do use the Control D Blood Glucose Monitoring System for :
Warning :
The Control D Blood Glucose Monitoring System contains small parts that may
be dangerous if swallowed.
Caution :Please read all the instructions provided in this manual and practice the testing
procedure before using the Control D Blood Glucose Monitoring System. Blood
glucose monitoring should be done with the guidance of a health care professional.
Testing Blood Glucose
Testing only with fresh capillary whole blood sample
Control D HAIDEN

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
Control D Blood Glucose Monitoring System. Avoid moles, veins,
bones, and tendons.
Alternate Test Sites
02
Control D Blood Glucose Monitoring System uses 0.5 µL
sample. So you can test on a variety of locations shown
above.
Note :
Control D HAIDEN
Upper arm
Forearm
Hand
Fingertips
Thigh
Calf
Suggested Test
Areas for the Hand

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.
2. Control D Glucometer & Blood Glucose Test Strip
03
Control D Glucometer and how it works
Control D HAIDEN
Test Strip Port
Insert the top end of
a new Control D test
strip here. The meter
powers on when you
insert the test strip.
Displa ys your tes t
r e s u l t s a n d o t h e r
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
Sample Area
Note: For the description see page No.5
1. Sample Area/
Absorbent Channel
3. Test Strip Handle
4. Contact Bars
2. Confirmation Window

Control D Glucometer Display
04
Indicates unit of
measurement.
Blood Drop Symbol
Strip Symbol
Test Result Area
Displays test results.
8.8.8.
Battery Symbol
This symbol works with
s t r i p s y m b o l i n 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.
mg/dL (U.S. Standard)
Control D HAIDEN

Apply blood to strip sample area per test.
Important Test Strip Information
Note: For further information, refer to the Control D Blood Glucose test strips
package insert.
The Control D Blood Glucose Test Strip has an operating at 2° to 50°C.
The Blood Glucose Test Strips stored at 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 Control D Blood Glucose test strips 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 Control D Blood Glucose test strips.
Control D Blood Glucose Test Strip
05
* Testing with Control D Glucometer requires a very small sample
size 0.5 µL of blood.
* Test Strips should be used only once. Discard the used test strips.
* After getting the blood drop, fill the test strip within 60 seconds.
1. The cap or vial contains drying agents that may be harmful if inhaled or swallowed
and may cause skin or eye irritation.
Note :
2. The Control D Glucometer should only be used with Control D Blood Glucose
test strips, using other test strips with this meter can produce inaccurate results.
Control D HAIDEN
Test Strip
Sample Area

Performing a blood glucose test
Insert test strip to turn ON the meter
Insert and slide a Control D Blood Glucose
test strips into the meter till it allows. The meter
turns ON.
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.
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.
06
Check the following items are present in the kit for your glucose test:
* Your Control D Glucometer with battery
* The Control D Blood Glucose test strips
* A lancing device to obtain blood using lancets.
Note:
To ensure accurate results, wash your hands and test site
(for example, your fingers) with soap and water. Make sure there is
no cream or lotion on the test site. Thoroughly dry your hands and test site.
3. Testing your Blood Glucose
Preparing to test your blood glucose,
Blood Drop and
Test Strip Symbols
System Check
8.8.8.
Control D HAIDEN

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 Control D lancing device.
( Page 9 to 11 )
Obtain a Blood Sample
Applying blood to the Control D Blood Glucose test strips
Note
We recommend that you test on your fingers for better results.
07
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 finger tip to obtain blood using lancing
device. Bring the Control D Blood Glucose test
strips to the blood sample at a slight angle
Lance your fingertip:
Note: Gently squeeze or massage your fingertip to
obtain a drop of blood.
The Control D Blood Glucose test strips acts like a
sponge and pulls the Blood into the strip through the
sample area. When the meter detects the blood,
you can hear a beep sound
Apply Blood Sample to the Strip
The test will be finished in 5 seconds.
your blood glucose results appears on the display
Displays result on the screen
Your results are saved automatically in the meter
Control D HAIDEN
1 02
mg/dL

4. Strip Ejection
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
The meter turns itself OFF.
Important Notes on testing glucose using Control D
Do not pull the Control D Blood Glucose test strips away until you hear a beep sound
or see the timer starting on your meter screen. This results that the meter has taken the
sufficient sample and testing your glucose.
If after 5 seconds your meter doesn’t show a timer starting on the display screen, the
sample may be too small or strip might be a faulty. Replace the new strip.
The test result is complete when your blood glucose lactate test result is shown on the
display screen and you hear a beep sound twice.
On average, your reading will display in 5 seconds.
Do not press the Control D Blood Glucose test strips against the test site.
Do not apply blood to the top side of the Control D Blood Glucose test strips.
Do not apply blood to the Control D Blood Glucose test strips when the test strip is out
of the meter.
Do not put blood or foreign objects into the Control D Blood Glucose test strips 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.
Do not scrape the blood onto the Control D Blood Glucose test strips.
Discard the used blood glucose test strip carefully. Used blood glucose test strip maybe
considered biohazardous waste in your area. Be sure to follow your healthcare
professionals recommendations or local regulations for proper disposal.
Note :
Control D HAIDEN
1 02
mg/dL

Below are the steps which
have to be followed to
ensure proper and safe usage
of the Lancets and Lancing
Device:
The lancing device is intended for the collection of capillary whole blood
sample for testing purposes from the fingertip and from other sites, such
as palm, upper arm, and forearm, which is referred to as alternate site
testing. The lancing device is for use only on a single patient.
Intended Use
Step 1:
Inserting a Lancet
Step 2:
Step 3:
Step 4:
5. Instructions for use of Lancing Device
Remove the cap from the lancing
device.
Insert a new lancet firmly into the
lancet holder as far as it will go.
Twist the protective cap to remove
from the lancet. (Don’t bend the
protective cap)
Place the cap back on to the device.
The cap must audibly click into place.
09
Control D HAIDEN

To Obtain a Blood Sample
Select the desired depth setting then pull
the plunger (on the end of the device) all
the way down & you hear a click. Then the
device is ready.
Step 5:
Wash your hands & dry them thoroughly.
Hold the lancing device against your finger
tip, then press the release button. The
lancet is released and it penetrates the skin.
Step 6:
Note :
The amount of blood that emerges depends on the penetration depth
and the pressure used to hold the lancing device against the skin.
1.
If not enough blood emerges, apply more pressure on the lancing device
when you next obtain blood. If that is not sufficient, increase the
penetration depth progressively in addition.
2.
If too much blood emerges, decrease the penetration depth.
3.
Test your blood glucose immediately after you obtained blood,
according to the instructions for use for your blood glucose meter.
4.
You can set the penetration depths
between (1 to 5). The larger the number
provides the greater penetration depth.
Penetration depth depends on the skin
thickness, If you have sensitive skin set a
low penetration depth below 3. Rotate
the lancing device dial until the desired
penetration depth is set.
Penetration Depth
10
Control D HAIDEN

Ejecting the used lancet
1. Remove the cap from lancing device.
2. Slide/Push the ejector forward. The used lancet is ejected.
3. Place the cap back on to the device.
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 unitended lancet stick injuries. Used lancets maybe
considered biohazardous waste in your area. Be sure to follow your
healthcare professionals recommendatios or local regulations for proper
disposal.
Note :
The Lancing Device has an ejection feature, so you do not have to
pull out the used lancet.
11
Control D HAIDEN

LO Reading with Symptoms
6. LO and HI Readings
Low or high blood glucose readings can indicate a potentially serious
medical condition. The Control D Glucometer displays results from
20 to 600 mg/dL
Important:
If your test result is above 500 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
If you feel symptoms such as fatigue, thirst, excess urination, or
blurry vision, then follow your doctor's recommendation to treat
hyperglycemia.
12
Control D HAIDEN

7. Meter Maintenance
Replacing the Battery
Battery
Your Control D Glucometer 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
Open the battery cover as
shown in the image
Control D HAIDEN

System Troubleshooting
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.
1. Never immerse the meter in water or any other liquid.
2. 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.
Important:
14
Error Messages
Possible Causes
Insufficient Sample
Er4
Error in Sample
Er5
Error in Operating Temperature
Er
f
Control D HAIDEN

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 Control D Blood Glucose
test strips 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
Control D Blood Glucose test strips
Sample applied after meter
times out (one minute) and
turns off.
15
What you should do
Be sure you see the blood drop and test strip symbols on the display screen
before you apply blood.
Control D HAIDEN

Assay Method
Automatic Shutoff
Amperometric Bio sensor
After 5 seconds, depending on
operating status
Battery Life
Approximately 1000 tests
Result Range
Sample
Sample Size
Meter Size (Centimeters)
Display Size (Millimeters)
Test Time
Weight
Strip Ejection
Construction
Protection Class
Meter Warranty
Hematocrit
Measurement Units
Strips Storage Temp.
Memory
15 % to 65 %
mg/dL
o o
0 to 50 C (Do not refrigerate)
500 Previous Readings
Operating Relative Humidity
Strips Shelf Life
Operating Temperature
Power Source
10 % to 95 % (non-condensing)
24 Months
o o
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
C
Lifetime
Test Principle
Determination of glucose in fresh
capillary whole blood
Handheld
16
8. Technical Specifications
Control D HAIDEN

17
Explanation of Symbols
These symbols may appear on the packaging of Control D
Blood Glucose Monitoring System
CE Marking
Manufacturer
Date of Manufacture
Use by Date
Batch Code
Serial Number
Keep Away from Sunlight
Storage & Operating Temperature
Do not reuse
Consult instructions for use
In vitro diagnostic medical device
Caution
Do Not Use if Package is Damaged
ISO Certified
ISO
Control D HAIDEN