OK Biotech ACCUREX XPRESSGLUCO+ User Manual

Blood Glucose Monitoring System
USER GUIDE
Before You Begin
Please Read This Before Using.
The following basic safety precautions should always be taken.
1. Close supervision is necessary when the device is used by, on, or near children,
handicapped persons or invalids.
2. Use the device only for the intended use described in this User Guide.
3. Do not use test strips and control solutions which are not supplied by the
manufacturer.
4. Do not use the device if it is not working properly, or if it has suffered any damage.
5. Before using any product to test your blood glucose, read all instructions thoroughly
and practice the test. Do all quality control checks as directed and consult with a
diabetes healthcare professional.
KEEP THIS USER GUIDE WITH YOU.
Intended Use
The system is intended for use outside the body (in vitro diagnostic use only). It
should be used only for self-testing blood glucose (blood sugar) and only with fresh
capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf
or thigh. The system is intended for use in the home and in clinical settings. The system
should not be used for the diagnosis of diabetes or for the testing of newborns.
Principle of Measurement
Blood glucose is measured by an electrical current that is produced when a blood
samples mixes with the reagent (special chemicals) of the test strip. The electrical
current changes with the amount of glucose in the blood sample. The X
meter measures the strength of the electrical current, calculates your blood glucose
level and then displays your result in either milligrams of glucose per deciliter (mg/dL)
or millimoles of glucose per liter (mmol/L).
1. Getting To Know Your System
The X G meter is available as a meter only or as a meter kit. Please review
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the contents of your purchase to confirm that all the components are included as
listed on the side of your meter box.
Use X G Blood Glucose Meter only with X
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Glucose Test Strips and X G Control Solution.
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Test Strip Slot
Insert the test strip here.
The meter will turn on
automatically.
LCD Display (Backlight)
Guides you through the
test using symbols and
simple messages.
The backlight is only activated
when the meter is in the working
condition.
Main Button
Turns the meter on or
performs other functions
described in this user guide.
Meter
Confirmation Window
Shows whether enough blood
has been drawn into the test
strip's absorbent channel.
Test Strip Handle
Hold this part to insert the
test strip into the test strip
slot on the meter.
Absorbent Channel
Apply a drop of blood
and it will be drawn in
automatically.
Test Strip
2.
Prepare For Blood Sampling
If your lancing device did not come with a lancing device insert, the following
information shall take the place of the insert.
Adjustable Lancing
Device and Lancet
Your lancing device Cocking Control
and lancets are used
for obtaining blood
Release Button
samples from the
puncture site.
Lancet Protective Cap
Important Lancing Device and
Lancets Information
Lancing Device Cap
1. Lancet is for single use only.
2. Keep lancing device and lancets clean.
3. Use caution when removing the used lancet from the device and when disposing
the used lancet.
Important :
• The meter and lancing device are for single patient use.
• Do NOT share them with anyone including other family members.
• Do NOT use on multiple patients.
For In vitro diagnostic use
Please consult instructions for use
Do not reuse
Lot number
Keep dry
Humidity limitation
Caution
1. The user should not take any decision of medical relevance without first consulting his
or her medical practitioner.
2. Call your doctor immediately if you experience symptoms that are not consistent with
your blood glucose test results.
3. High altitudes above than 3,402 meter (11,161 ft) may affect the test results.
4. Temperatures outside the range of 10°C to 40°C (50°F to 104°F) may affect the test
results. Do not test beyond of temperature range.
5. Do not perform servicing and maintenance while the meter is in use.
6. No modification of this equipment is allowed.
7. Do not use this meter near cellular or cordless telephones in a call, walkie-talkies,
garage door openers, radio transmitters, or other electrical or electronic equipment
that are sources of electromagnetic, radiation, as these may interfere with the proper
operation of the meter.
Important Health-Related Information
1. Apply only capillary whole blood sample to test your blood glucose. Applying other
substances or plasma, serum will cause wrong results.
2. Severe dehydration and excessive water loss may cause false low results. If you believe
you are suffering from severe dehydration, consult your healthcare professional
immediately.
3. Test results below 60 mg/dL (3.3 mmol/L)*1 indicates low blood glucose
(hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L)*2 indicates high
blood glucose (hyperglycemia).If your results are below 60 mg/dL (3.3 mmol/L) or
above 240 mg/dL (13.3 mmol/L), repeat the test, and if the results are still below 60
mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare
professional immediately.
G 4. Inaccurate results may occur in severely hypotensive individuals or patients in shock.
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Inaccurate low results may occur for individuals experiencing a hyperglycemic-
hyperosmolar state, with or without ketosis. Critically ill patients should not be tested
with blood glucose meters.
Temperature Symbol
Appears when
temperature is outside of
operating range.
Control Solution Test
Symbol
G Blood Shows that you are in
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control solution mode.
Test Strip Symbol
Appears when the meter
is in testing mode.
Low Battery Symbol
Appears when the battery
power is low.
If any part of the display is not working,
contact your local distributor for help.
Battery
X G meters come with Two (2) CR2032 lithium battery. The battery is
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manufactured in a charged state and not designed for recharging. Recharging the battery
can cause battery leakage, or in some cases, high pressure rupture.
Test Range Indicator
Warning : Batteries can explode or leak and cause burns if installed backwards,
disassembled, charged or exposed to water, fire or high temperatures.
Set Button
Used to set up the
Low Battery
meter.
The meter will alert you when the power is getting low by displaying two (2) different
messages:
1. When the " " symbol appears alone on the display, the meter is functional and the
results remain accurate, but you should change the batteries as soon as possible.
2. When the " " symbol appears together with the "E-b" symbol on the display, the
battery does not have enough power for a test. You must change the battery before
using the meter.
Contact Bars
Insert this end of the test
strip into the meter.
Push it in firmly until it will
not go any further.
Caution:
• As with all small objects, the batteries should be kept away from small children. If the
battery is swallowed, seek medical assistance immediately.
• Remove the batteries if you are not going to use the device for a long period of time
(i.e., 3 months or more), or the batteries might leak chemicals.
Setting your Lancing Device
Lancet Ejector
Lancet Holder
Arrow
Adjustable Tip
Temperature limitation / Store at
Use by /Expiry date
Manufacturer
Caution, consult accompanying document
Keep away from sunlight
XPRESSGLUCO+3DL-UG C-MAR22
ACCUREX BIOMEDICAL PVT. LTD.
G-54/55, MIDC Tarapur, Boisar, Palghar - 401 506, India
Customer Support No: 1800 209 8456
Tel: +91 96078 99114 ． Email: info@accurex.net
URL: www.accurex.net
OK Biotech Co., Ltd.
No. 91, Sec. 2, Gongdao 5th Road,
30070 Hsinchu City, TAIWAN
www.okbiotech.com
Time Date
Day Average
Indicates that the displayed
test result is an average.
Memory Symbol
Appears when you review the
memory.
Test Result Area
Displays test results.
Unit of Measure
Indicates what unit of
measure the test result is
displayed in.
Arrows
Display arrows according to
measured values
Left :Lower than the target range
Middle:Within the target range
Right:Higher than the target range
STEP 1 : With the meter off, press the mark on the battery
cover and slide up to open the cover.
STEP 2 : Remove the old battery by pressing on the buckle beside
the battery and gently pulling it at the same time.
STEP 3 : Replace with a new battery. Be sure to align the battery
properly with the positive (+) side up.
STEP 4 : Close the battery cover. If the meter does not power
on and enter setting mode after you have replaced the
battery, check that the battery is correctly installed.
Replacing the battery does not affect the meter's memory
(previous test results stored in memory). However, the date, time
and unit settings may need to be updated; update the settings by
following the steps in "Setting Time and Date".
STEP 1:
Insert a new sterile lancet into the Lancet Holder. Push down
firmly until it is fully seated.
STEP 2 :
Twist off the Lancet Protective Cap and save the Cap for later
use. Replace the Lancing Device Cap.
STEP 3 :
Set the lancing level by twisting the Adjustable Tip until the
number lines up with the Arrow.
To select the best depth:
1-2 for soft or thin skin
3 for average skin
4-5 for thick or calloused skin
STEP 4 :
Slowly pull back the Cocking Control. You will hear a click,
indicating that the Lancing Device is now loaded and ready to
use.
A :
1 . Getting To Know Your System
SIDE
2. Prepare For Blood Sampling
3. Understanding Your Test Result
B :
SIDE 4. Performing Blood Test
5. Alternative Site Testing
6. Control Solution Testing
7. Memory Recall
8. Caring For Your Meter And Test Strip
9. Specifications
10. System Troubleshooting
11.Performance Characteristics
5. Abnormal red blood cell counts (hematocrit level between 35~50%) may cause
false results. Please consult your healthcare professional if you do not know your
hematocrit level.
6. Interference: Reducing substances occurring in the blood naturally (uric acid,
bilirubin) or from therapeutic treatments (ascorbic acid, acetaminophen) will not
significantly affect X G test results. However, elevated concentrations of
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these substances may affect test results. The compounds listed in the table were
found to have no affect at the concentration indicated.
Compounds Concentrations higher than Compounds
the following values may
cause inaccurate results
Acetaminophen 8.0 mg/dL (0.53 mmol/L) Hydroxyurea
Ascorbic Acid 5.0 mg/dL (0.28 mmol/L) Ibuprofen
Aspirin 60 mg/dL (3.33 mmol/L) Icodextrin
Bilirubin 90 mg/dL (1.54 mmol/L) L-dopa
Cholesterol 500 mg/dL (12.9 mmol/L) Maltose
Creatinine 5.0 mg/dL (0.44 mmol/L) Methyldopa
Dopamine 2.0 mg/dL (0.11 mmol/L) Pralidoxime Iodide 25 mg/dL (0.94 mmol/L)
EDTA 360 mg/dL (12.3 mmol/L) Salicylate
Galactose 900 mg/dL (50 mmol/L) Tolazamide
Gentisic Acid 5.0 mg/dL (0.32 mmol/L) Tolbutamide
Glutathione 53 mg/dL (1.72 mmol/L) Triglycerides
Haemoglobin 500 mg/dL (0.08 mmol/L) Uric Acid
Heparin 8,000 U/dL Xylose
REFERENCE:
* 1: Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus, 13thed Philadelphia : Lea and Febiger (1994), 489.
* 2: Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual. Philadelphia : Lea and Febiger(1989), 261-263.
Setting the Meter
Please install battery first and set correct time and date before you begin to test.
STEP 1: Enter Setting Mode
If your meter is off, press the "S" button. The meter is now in the setting
mode.
STEP 2 : Set the Year
Press and release the " " button to advance the year. With the correct
year on the display, press the "S" button and the date will appear on the
display with the month segment flashing.
STEP 3 : Set the Month
Press and release the " " button to advance the month. With the correct
month on the display, press the "S" button and the date segment will start
flashing.
STEP 4 : Set the Date
Press and release the " " button to advance the date. With the correct
date on the display, press the "S" button and the time will appear on the
display with the hour segment flashing.
STEP 5 : Set the Hour
Press and release the " " button to advance the hour. With the correct
hour on the display, press the "S" button and the minutes segment will
start flashing.
STEP 6 : Set the Minutes
Press and release the " " button to advance the minutes. With the correct
minutes on the display, press the "S" button and the current unit of
measurement will start flashing.
STEP 7 : Select Unit of Measurement
Press the " " button to select the unit of measurement. To skip this step,
press the "S" button.
Your meter can display test results in milligrams per deciliter (mg/dL)
or millimoles per liter (mmoL/L). Please set the unit of measurement
according to the standard unit in your region.
STEP 8 : Delete All Memory
When the "dEL" symbol and the flashing "
display, you can choose to clear the memory. If you do not want to clear
the memory, press the "S" button again to skip this step.
If you want to clear ALL memory, press the main button for five
(5) seconds. The " " will appear to indicate all memory has
been deleted and the meter will turn off.
The Target Range Adjustment Mode
The default target range is 70 mg/dl (low threshold) to180 mg/dl (high threshold).
You can set the low threshold to values from 60 mg/dl to 90 mg/dl, and the high threshold
from 120 mg/dl to 300 mg/dl.
The target range can be set only when the meter has no memory. If there are existing
memory records in the meter, refer to Setting the Meter section to delete all memory.
While the meter is turned off, press the " " button to turn the meter on.
Press the " " button again to enter memory mode.
In the memory mode, press the "S" button and " " button simultaneously to
start setting the low threshold of the target range.
To adjust the low threshold, press " " to reduce the value and Press "S" to
increase the value. Press "S" and " " button simultaneously to confirm the
setting, and move on to set the high threshold.
To adjust the high threshold, press " " to reduce the value and Press "S" to
increase the value. Press "S" and " " button simultaneously to complete the
setting. "OFF" is displayed and the meter will turn off.
3.
Understanding Your Test Result
.
The normal blood glucose range is below 100 mg/dL (5.6 mmol/L) for a fasting, non-
diabetic adult, but less than 140 mg/dL (7.8 mmol/L) two hours after meals.* Consult your
healthcare professional to find out your target blood glucose value.
If your blood glucose result seems unusually high or low, or inconsistent with your
previous results, check the following:
1. Was the blood sample applied immediately to the test strip after removing it from the
vial?
2. Was the volume of the blood sample sufficient?
3. Was the test strip vial cap tightly sealed?
4. Was the test strip used before the expiration date?
5. Were the test strips stored away from extreme temperatures in very cold or hot
weather or from areas of high humidity?
Then run a control test with control solution. If the control test result is within the
acceptable range, review testing procedure and repeat your blood glucose test with a
new test strip. If your blood glucose value is still inconsistent with your previous results,
glucose trend, or how you feel, contact your doctor immediately for help.
Reference:
* American Diabetes Association Website (http://www.diabetes.org)
Concentrations higher than
the following values may cause
inaccurate results
3.0 mg/dL (0.39 mmol/L)
50 mg/dL (2.42 mmol/L)
13 mg/dL (0.01 mmol/L)
10 mg/dL (0.51 mmol/L)
900 mg/dL (26.3 mmol/L)
3.0 mg/dL (0.13 mmol/L)
60 mg/dL (4.34 mmol/L)
100 mg/dL (3.21 mmol/L)
400 mg/dL (14.8 mmol/L)
2,000 mg/dL (22.6 mmol/L)
8.0 mg/dL (0.48 mmol/L)
100 mg/dL (6.66 mmol/L)
" symbol appear on the