Self monitoring of blood glucose (SMBG) is an integral part of diabetes care, but
the high cost of testing can make this impossible. At GIMA, our goal is to provide
high quality glucose monitoring at a price that allows you to test as often as
necessary. Together, we can better manage your diabetes and help you live a
longer and healthier life.
Welcome, and thank you for choosing the GIMA Blood Glucose Monitoring
System. The GIMA Blood Glucose Monitoring System will give you accurate blood
glucose results from Capillary, Arterial, Venous and Neonatal blood samples in just
a few simple steps. GIMA may be used by people with diabetes at home and by
healthcare professionals for the quantitative measurement of glucose in capillary
whole blood from the finger, forearm, and palm. Only professionals may also test
neonatal, arterial and venous blood samples.
To ensure accurate results from your GIMA Blood Glucose Monitoring System,
please follow these guidelines:
Read instructions before use.
Use only GIMA Blood GlucoseTest Strips with the GIMA Blood Glucose
Meter.
For in vitro diagnostic use only. Your blood glucose monitoring system is to be
used only outside the body for monitoring the effectiveness of diabetes control.
It should not be used for the diagnosis of diabetes.
For self testing and professional use.
Test only whole blood samples with the GIMA Blood GlucoseTest Strips and
Meter.
For self-testers, consult your physician or diabetes healthcare professional
before making any adjustments to your medication, diet or activity routines.
Keep out of reach of children.
By following the instructions outlined in this User's Manual, you will be able to use
your GIMA Blood Glucose Monitoring System to monitor your blood glucose and
better manage your diabetes.
i
Table of Contents
Getting Started .................................................................................................... 1
Component Descri
GIMA Blood
Meter Display .............................................................................................
GIMA Blood
lucose Control Solution .................................................................. 9
GIMA G
Installing the B
Meter Setup Befo
Performing a Quality Control Test ....................................................................19
Testing Your Blood ............................................................................................22
Before testing, read the instructions carefully and learn about all the components
of your GIMA Blood Glucose Monitoring System. Depending on the GIMA product
you purchased, some of the components may need to be purchased separately.
Please check the list of contents on the outer box for details on which components
are included with your purchase.
Test Strips
Blood Glucose Meter
Sterile Lancet
Lancing Device
Carrying Case
1
Control Solution
Clear Cap
Component Descriptions
1. Blood Glucose Meter: Reads the test strips and displays the blood glucose
concentration.
2. Test Strips: Strips with a chemical reagent system used with the meter to
measure glucose concentration in blood.
3. Lancing Device: Used with sterile lancets to prick the fingertip blood sample
collection. The packaged lancing device has multiple depth settings, allowing
users to adjust the depth of the puncture and minimize discomfort. It can also
eject the used lancets.
4. Clear Cap: Used with the lancing device and sterile lancet to draw a blood
sample from the forearm or palm.
5. Sterile Lancets: Used with the lancing device to draw a blood sample. Sterile
lancets are inserted into the lancing device with each blood draw and
discarded after use.
6. Control Solution: Verifies the proper operation of the blood glucose monitoring
system by checking the test strips and meter against a pre-calibrated control
solution. Control Solution 1 is all you need most of the time. If you want to do
additional levels of test, Control Solution 0 and Control Solution 2 are
available. The three levels of control solution, CTRL 0, CTRL 1 and CTRL 2
are available in the GIMA Glucose Control Solution package which is sold
separately.
7. Carrying Case: Provides portability for blood glucose testing wherever you go.
8. User's Manual: Provides detailed instructions on using the blood glucose
monitoring system.
9. Quick Reference Guide: Provides a brief overview of the blood glucose
monitoring system and testing procedures. This small guide can be kept in
your carrying case.
10. Warranty Card: Should be completed and returned to the distributor to qualify
for the 5-year meter warranty.
2
GIMA Blood Glucose Meter
The meter reads the test strips and displays the blood glucose concentration. Use
these diagrams to become familiar with all the parts of your meter.
▼ Button
Data Port
Strip Port
Strip Ejector
Liquid Crystal
Display (LCD)
▲ Button
OK Button
Battery Cover
3
Strip Port: Test strips are inserted into this area to perform a test.
Strip Ejector: Slide the ejector forward to discard the used test strip.
Note: Dispose of blood samples and materials carefully. Treat all blood samples
as if they are infectious materials. Follow proper precautions and obey all local
regulations when disposing of blood samples and materials.
Liquid Crystal Display (LCD): Shows your test results, and helps you through
the testing process.
▼ Button: Recalls previous test results from the meter memory and performs
other menu selection functions.
▲ Button: Selects meter settings and performs other menu selection functions.
OK Button: Used to manually turn the meter on or off, check the display to
confirm that all the display segments turn on, and check the date/time.
Data Port: Sends information to a computer via an optional data transfer cable to
view, analyze and print stored data in the meter. The data transfer cable is
available for order as an optional add-on.
Battery Cover: Remove the battery cover to install two CR2032 coin cell
batteries.
4
Meter Display
Date Hour Minutes
Blood Drop /
Strip Symbol
Test Result
Pound Sign (#)
Battery Symbol: Warns when you should replace the battery.
Control Solution Symbol: Indicates a control test result. A pound sign (#) will
also be displayed when control solution symbol appears.
Before Meal Symbol: Appears when you mark the result as a before-meal test
results.
After Meal Symbol: Appears when you mark the result as an after-meal test
results.
Measurement Unit: Only one unit will be displayed on your meter and cannot be
adjusted.
Hyper Symbol: Appears when the blood glucose concentration is above the
target “Hyperglycemia” (high blood sugar) level that you have set.
Hypo Symbol: Appears when the blood glucose concentration is below the
“Hypoglycemia” (low blood sugar) target level that you have set.
Test Remind Symbol: Reminding you to test blood glucose.
Blood Drop / Strip Symbol: Wait for the Blood Drop / Strip Symbol to appear
before applying the sample. These two symbols appear at the same time to tell
you when to apply the sample.
Test Result Area: Indicates test result.
Pound Sign (#): Appears with the control solution test result or when you mark an
invalid result to prevent it from being included in the average.
MEM: Shows a test result stored in memory.
Ketone: Appears when the blood glucose concentration is above 16.7 mmol/L
(300 mg/dL). This simply suggests that a ketone test is recommended. Consult
Area
Memory
Ketone
Test Remind Symbol
Hypo Symbol
5
Battery Symbol
Control Solution
Symbol
Before Meal Symbol
After Meal Symbol
Measurement Unit
Hyper Symbol
your healthcare professional about testing for ketones.
Note: This symbol does not mean that the system has detected ketones. It
recommends that a ketone test should be taken.
Meter Use and Precautions
Wait for the Blood Drop and Strip Symbol to appear together before applying
the sample.
The meter is preset to display blood glucose concentration in either millimoles
per liter (mmol/L) or milligrams per deciliter (mg/dL) depending on which unit
of measure is standard in your country. This unit of measure cannot be
adjusted.
Meter will shut off automatically 2 minutes after inactivity.
Do not get water or other liquids inside the meter.
Keep the strip port area clean.
Keep your meter dry and avoid exposing it to extreme temperature or humidity.
Do not leave it in your car. Please use the meter indoor.
Do not drop the meter or get it wet. If you do drop the meter or get it wet,
check the meter by running a quality control test. Refer to Performing a Quality Control Test on page 19 for instructions.
Do not take the meter apart. Taking the meter apart will void the warranty.
Refer to the Maintenance section on page 36 for details on cleaning the
meter.
Keep the meter and all associated parts out of reach of children.
Note: Follow proper precautions and all local regulations when disposing of the
meter and used batteries.
All Glucose Systems Preventive Warnings with Regard to EMC:
This instrument is tested for immunity to electrostatic discharge as specified in
IEC 61000-4-2. However, use of this instrument in a dry environment,
especially if synthetic materials are present (synthetic clothing, carpets, etc.)
may cause damaging static discharges that may cause erroneous results.
This instrument complies with the emission and immunity requirements
described in EN61326-1 and EN61326-2-6. Do not use this instrument in
close proximity to sources of strong electromagnetic radiation, as these may
interfere with proper operation of the meter.
For professional use, the electromagnetic environment should be evaluated
prior to operation of this device.
6
GIMA Blood Glucose Test Strips
The GIMA Blood Glucose Test Strips are thin strips with a chemical reagent which
work with the GIMA Blood Glucose Meter to measure the glucose concentration in
whole blood. After the strip is inserted into the meter, blood is applied to the
sample tip of the test strip. The blood is then automatically absorbed into the
reaction cell where the reaction takes place. A transient electrical current is
formed during the reaction and the blood glucose concentration is calculated
based on the electrical current detected by the meter. The result is shown on the
meter display. The meter is calibrated to display plasma equivalent results.
Sample Tip
Apply blood or control solution here.
Check Window
Check to confirm that a sufficient
sample size has been applied.
IMPORTANT: Apply the sample only to the sample tip of the test strip. Do not
apply blood or control solution to the top of the test strip as this may result in an
inaccurate reading.
Hold the blood drop to the sample tip
of the test strip until the check window
is completely full and until the meter
begins to count down. If you applied
blood but do not see the starting of the
count down, you may reapply a
second drop of blood within 3 seconds.
If the check window does not fill and
the meter starts to count down, then
do not add more blood to the test strip.
If you do then you may get an E-5
message or an inaccurate test result.
In this case if the meter begins to
count down and the check window
does not fill, discard the strip and begin the test again with a new test strip.
Contact Bars
Insert this end of the test strip
into the meter until it stops.
Correct
Correct
7
Incorrect
Incorrect
Storage and Handling
Please review the following storage and handling instructions:
Store test strips in a cool, dry place at 2 - 35 °C (36 - 95 °F). Store them away
from heat and direct sunlight.
Do not freeze or refrigerate.
Do not store or use test strips in a humid place such as a bathroom.
Do not store the meter, the test strips or control solution near bleach or
cleaners that contain bleach.
The test strip should be used immediately after removing it from the container.
Repeated insertion and removal of a test strip into the meter strip port may
result in reading errors.
Do not use your test strips past the unopened expiration date printed on the
label. Using test strips past the unopened expiration date may produce
incorrect test results.
Note: The expiration date is printed in Year-Month-Date format.
Special Instructions for Test Strip in the Vial
Test strips must be stored in the original vial with the cap tightly closed. This
keeps them in good working condition.
Do not transfer test strips to a new vial or any other container.
Replace the cap on the test strip vial immediately after removing a test strip.
A new vial of test strips may be used for 6 months after being first opened.
Write the opened expiration date on the vial label after opening. Discard the
vial 6 months after you first open it. Usage after this period may result in
inaccurate readings.
Special Instructions for Test Strip in the Foil Pouch
Tear the pouch carefully starting from the tear gap. Avoid damaging or
bending the test strip.
Use the test strip immediately after removing it from the pouch.
8
Test Strip Precautions
For in vitro diagnostic use. Test strips are to be used only outside the body for
testing purposes.
Do not use test strips that are torn, bent, or damaged in any way. Do not reuse
test strips.
Keep the test strip vial or the foil pouch away from children and animals.
Consult your physician or healthcare professional before making any changes
in your treatment plan based on your blood glucose test results.
See the test strip insert for more details.
GIMA Glucose Control Solution
The GIMA Glucose Control Solution contains a known concentration of glucose. It
is used to confirm that your GIMA Blood Glucose Meter and test strips are
working together properly and that you are performing the test correctly. It is
important to run a quality control test regularly to make sure you are getting
correct results.
You should run a quality control test:
Before you first use your meter, to familiarize yourself with its operation.
Before using a new box of test strips.
When you suspect that the meter or test strips are not working
properly.
When you suspect that your test results are inaccurate, or if
they are inconsistent with how you feel.
When you suspect your meter is damaged.
After cleaning your meter.
At least once a week.
Refer to Performing a Quality Control Test on page 19 for instructions on
running a quality control test.
9
Storage and Handling
Please review the following storage and handling instructions:
Store the control solution at 2 - 35 °C (36 - 95 °F).
Do not refrigerate or freeze.
If the control solution is cold, do not use until it has warmed to room
temperature.
Use before the unopened expiration date that is shown on the bottle.
Note: The expiration date is printed in Year-Month-Date format.
Each bottle of control solution can be used for 6 months after you first open it.
Record the opened and the resulting expiration date on the bottle label.
Control Solution Precautions
For in vitro diagnostic use. The control solution is for testing only outside the
body. Do not swallow or inject.
Shake well before using.
Control solution tests are specified to be accurate only when tested between
10 and 40 °C (50 - 104 °F).
The control ranges shown on the test strip vial (or on the foil pouch) are not
recommended ranges for your blood glucose level. Your personal blood
glucose target ranges should be determined by your diabetes healthcare
professional.
Do not touch the test strip with the tip of the control solution bottle.
Use only the same brand of control solution that was provided with your kit.
See the control solution insert for more details.
10
Installing the Battery
Batteries may not be preinstalled in the meter. Two CR 2032 3.0 V coin cell
batteries are required. Please find the batteries in your carrying case and install
them according to the following steps:
1. Turn over the meter to locate the battery cover. Slide the battery cover in the
direction of the arrow to open it.
2. Insert two new CR 2032 3.0 V coin cell batteries on top of the plastic tape.
Make sure it is aligned with the plus (+) side facing up in the battery carrier.
3. Close the battery cover and make sure that it snaps shut.
11
Meter Setup Before Testing
Before using your meter for the first time, you will need to adjust the settings that
are listed in detail below.
1. Meter Setup Mode: Press the ▲ button for 2 seconds to enter the meter
setup mode. The meter will automatically enter the setup mode when turned
on for the first time by any method.
2. Clock: Set the clock for either 12 or 24 hour mode. Press the ▼ or ▲ button
to switch between the two settings. Then press the OK button to save your
choice and then start setting the date format.
Note:The clock needs to be reset after replacing the battery.
OR
3. Date Format: m-d or d-m will appear at the top of the display to indicate either
a month-date-year format or a date-month-year format. Press the ▼ or ▲
button to switch between the two settings. Then press the OK button to save
your choice and then start setting the year, month and date.
OR
4. Date: The year will appear at the top of the display. Press the ▼ or ▲ button
to increase or decrease the year. Once you have selected the correct year,
press the OK button to save your choice and start setting the month. Press
the ▼ or ▲ button to increase or decrease the month. Then press the OK
button to save your choice and start setting the date. Press the ▼ or ▲ button
to increase or decrease the date. Then press the OK button to save your
choice and start setting the time.
12
r
r
Year Month Date
5. Time: The hour will appear at the top of the display. Adjust the hour with the
▼ or ▲ button until the correct hour is displayed. Press the OK button to save
your choice and set the minutes. Press the ▼ or ▲ button to change to the
correct minute. Press the OK button to save your choice and move to set the
meal marker feature.
Hou
Hou
OR
Minute Minute
OR
6. Meal Marker: The meter comes with the meal marker feature disabled. The
meter allows the user to enable or disable the meal marker option. The words
“On” or “OFF” will be displayed on the large center segments of the display
and the before meal symbol together with the after meal symbol will be
displayed as shown below.
OR
13
Press the ▼ or ▲ button to switch between turning the meal marker “On” and
“Off”. Press the OK button to confirm your selection.
7. Audio Feature: The meter comes with the meter audio feature enabled. The
meter will give one short beep when it is turned on, after sample detection and
when the result is ready. The meter will sound three short beeps to sound a
warning when an error has occurred. Please check the error number on the
display to confirm what kind of error has occurred.
OR
Press the ▼ or ▲ button to switch between turning the meter beep “On” and “Off”.
Press the OK button to confirm your selection.
8. Ketone Indicator: The meter comes with the Ketone indicator feature
disabled. Press the ▼ or ▲ button to switch between turning the Ketone
indicator “On” and “Off”. Press the OK button to confirm your selection. When
the Ketone indicator is enabled, if the test result is higher than 16.7 mmol/L
(300 mg/dL), the symbol of "Ketone?" will appear on the display.
OR
9. Hyper Indicator: The meter comes with the Hyper indicator feature disabled.
Press the ▼ or ▲ button to switch between turning the Hyper indicator “On”
and “Off”. Press the OK button to confirm your selection. When the Hyper
indicator is “Off”, pressing the OK button will go to the next Hypo indicator set
up. When the Hyper indicator is “On”, pressing the OK button will go to the
Hyper indicator level set up. At the Hyper level set up, press the ▼ or ▲
button to adjust the Hyper level then press the OK button to go to the Hypo
indicator set up.
14
OR
Note: The meter allows the hyperglycemia level to be as low as 6.7 mmol/L
(120 mg/dL) or higher. The hyperglycemia level should be above the
hypoglycemia level. Consult your diabetes healthcare professional before
determining what your hyper blood glucose level is.
10. Hypo Indicator: The meter comes with the Hypo indicator feature disabled.
Press the ▼ or ▲ button to switch between turning the Hypo indicator “On”
and “Off”. Press the OK button to confirm your selection. When the Hypo
indicator is “Off,” pressing the OK button will go to the Test Reminder set up.
When the Hypo indicator is “On”, pressing the OK button will go to the Hypo
indicator level set up. At the Hypo level set up, press the ▼ or ▲ button to
adjust the Hypo level then press the OK button to go to the Test Reminder set
up.
OR
Note: The meter allows the hypoglycemia level to be as high as 5.6 mmol/L
(100 mg/dL). The hypoglycemia level should be below the hyperglycemia
level. Consult your diabetes healthcare professional before determining what
your hypo blood glucose level is.
11. Test Reminder: Test reminders are a useful way to remind you when to test.
You can set 1 to 5 reminders per day. Your meter is preset with the test
reminder disabled. You must turn it on to use this feature.
Press the ▼ or ▲ button to switch between turning the first Test Reminder
“On” and “Off”. Press the OK button to confirm your selection. When the
Test Reminder is “Off”, pressing the OK button will go to the set up of the
second Test Reminder. When the Test Reminder is “On”, pressing the OK
button will go to the set up of the time for the first Test Reminder. Press the
▼ or ▲ button to adjust the first Test Reminder time. Press the OK button
15
to confirm the first Test Reminder time and then go to the second Test
Reminder set up.
When the Test Reminder is “Off” during the second Test Reminder set up,
pressing the OK button will go to the set up of the third Test Reminder.
When the Test Reminder is “On”, pressing the OK button will go to the set
up of the time for the second Test Reminder. Press the ▼ or ▲ button to
adjust the second Test Reminder time. Press the OK button to confirm the
second Test Reminder time and then go to the third Test Reminder set up.
Repeat the same set up procedure for Test Reminder 3, 4 and 5.
After finishing the fifth Test Reminder set up, it will then end the setup
mode and power off the meter.
If one or more test reminders have been set, the reminder symbol will always
appear on the LCD screen when the meter is turned on. The display sample is
shown below.
OR
The meter beeps 5 times at the time you set, again two minutes later, and two
minutes after that unless you insert a test strip or press any button. This
function will still work with Audio feature turned off.
When the meter beeps at the time set by the Test Reminder feature, the date,
time and strip symbol will be displayed. And the Test Reminder symbol will be
flashed. The display sample is shown below.
Note: For any step of the set up, if the ▼ or ▲ button is pressed and held, it
will allow a faster adjustment.
12. Post – Prandial Alarm Function: The post prandial alarm function is an
optional function that you can use to setup a quick test reminder alarm. The
16
alarm has a distinct beep sound that is different from other meter sounds like
meal markers and test reminders. You can start setting up an alarm by
pressing ▼ and OK buttons together when the meter is off.
After pressing▼ and OK buttons, the interface with default 120 min and a
clock icon with on/off status will appear on the screen. You can increase the
number of minutes by pressing ▲ button and decrease the number of
minutes by pressing ▼ button. The time increments are in intervals of 15
minutes. The maximum number of minutes that the post prandial alarm allows
user to setup are 480 minutes. The minimum number of minutes that the post
prandial alarm allows user to setup are 15 minutes.
Press OK to confirm and the alarm will beep twice with the clock icon flashing
with screen display “On” to indicate that the alarm has been successfully set.
You can exit out of the interface by pressing▼ and OK buttons together, or
the meter will be turned off after 60 seconds of inactivity.
17
The alarm will beep at the minute mark set by you. You can always go back
and change the alarm time if needed after setting up the alarm. To do so,
press ▼ and OK buttons together and the post prandial alarm interface will
appear and display the time remaining. You can switch off the alarm by
pressing and holding OK button for 2 seconds. You can also navigate and
change the alarm time by pressing ▲ or ▼ buttons and re-confirm by
pressing OK button. You can always exit out of the post prandial alarm
interface by pressing ▼ and OK buttons.
The alarm will beep at the time set by you. The meter screen will display test
strip, time and date to remind you to measure your post – prandial blood
glucose while the meter beeps. The meter will beep for 20 seconds and
alarm will be switched off after 20 seconds. You can snooze the alarm by
pressing OK button
The alarm will be switched off automatically when you insert a test strip.
18
Performing a Quality Control Test
The quality control test confirms that the test strips and meter are working
together properly, and that you are performing the test correctly. It is important to
perform this test:
Before you first use your meter.
Before using a new box of test strips.
When you suspect that the meter or test strips are not working properly.
When you suspect that your test results are inaccurate, or if they are
inconsistent with how you feel.
When you suspect your meter is damaged.
After cleaning your meter.
At least once a week.
1. Insert a test strip into the strip port, contact bars end first and facing up, to turn
on the meter and display all the display segments. If the audio option is on,
the meter will beep, signaling the meter is turned on.
2. Check the display to confirm that all the display segments turn on. Next, a
dash will move across the display. See illustrations below.
NOT READY NOT READY NOT READY
3. The meter is ready for testing when the blinking blood drop and strip symbol
appear. The display will show the date time and the strip icon with the blood
sample icon blinking to indicate that the test strip is inserted correctly. You can
then add a drop of control solution.
READY TO TEST
Note: If the test strip has been inserted incorrectly, the meter will not turn on.
19
4. Shake the control solution bottle well, then squeeze it gently and discard the
first drop. If the tip clogs, tap the tip gently on a clean, hard surface. Then
shake again and use. Squeeze out a second small drop on a clean
nonabsorbent surface. Touch the sample tip of the test strip to the control
solution drop. If the audio option is turned on, the meter will beep to indicate a
sufficient sample has been applied.
Notes:
Do not apply control solution to the test strip directly from the bottle.
If you applied the control solution sample but do not see the starting of the
count down, you may reapply a second drop within 3 seconds.
5. Once a sufficient sample has been applied, the meter display will count down
from 5 to 1 and then the result and a control solution symbol will be displayed
on the screen. The control solution test results should be within the control
range (CTRL 1) printed on the test strip vial (or on the foil pouch). This means
that your blood glucose monitoring system is working properly and that you
are performing the procedure correctly.
OR
Test results are displayed either in mmol/L or mg/dL depending on the unit of
measure most common in your country.
Note: The control solution range is the expected range for the control solution
results. It is not a recommended range for a blood glucose level.
6. Slide forward the strip ejector to discard the used test strip.
The display should also show a pound sign (#) indicating the test is a control
solution test. This shows that the number will not be counted in the 7, 14, 30,
20
60 and 90-day averages. The pound sign (#) will also be displayed when
reviewing the results stored in memory.
If the result falls outside the indicated control range:
Confirm you are matching the correct range. Control Solution 1 results
should be matched to the CTRL 1 range printed on the test strip vial (or on
the foil pouch).
Check the expiration date of the test strip and control solution. Make sure
that the test strip vial and control solution bottle have not been opened for
more than 6 months. Discard any test strips or control solution that has
expired.
Confirm the temperature in which you are testing is between 10 and 40 °C
(50 – 104 ºF).
Make sure that the test strip vial and control solution bottle have been
tightly capped.
Confirm that you are using the same brand of control solution that was
provided with your kit.
Make sure that you followed the test procedure correctly.
After checking all of the conditions listed above, repeat the quality control test with
a new test strip. If your results still fall outside of the control range shown on the
test strip vial (or on the foil pouch), your meter may be defective. Contact your
local distributor for help.
Three levels of control solution are available labeled Control Solution 0, Control
Solution 1 and Control Solution 2. Control Solution 1 is sufficient for most all
self-testing needs. If you think your meter or strips may not be working correctly,
you may also want to perform a CTRL 0 or CTRL 2 test. The ranges for CTRL 0,
CTRL 1 and CTRL 2 are displayed on the test strip vial (or on the foil pouch).
Simply repeat step 4 through 6, using Control Solution 0 or Control Solution 2.
For confirmation of results, Control Solution 0 tests should fall within the CTRL 0
range, Control Solution 1 tests should fall within the CTRL 1 range and Control
Solution 2 tests should fall within the CTRL 2 range. If the control solution test
results do not fall within the respective ranges, DO NOT use the system to test
blood, as the system may not be working properly. If you cannot fix the problem,
contact your local distributor for help.
Please contact your local distributor for information on ordering the GIMA Glucose
Control Solution kit, which contains Control Solution 0, Control Solution 1 and
Control Solution 2.
21
Testing Your Blood
The following steps will show how to use the meter, test strips, lancing device and
sterile lancets together to measure your blood glucose concentration.
Step 1 – Getting a Drop of Blood
The GIMA Blood Glucose Monitoring System requires a very small drop of blood
which may be obtained from the fingertip, palm (at base of the thumb) or forearm.
Before testing, choose a clean, dry work surface. Familiarize yourself with the
procedure and make sure you have all the items needed to obtain a drop of blood.
IMPORTANT: Prior to testing, wipe the test site with an alcohol swab or soapy
water. Use warm water to increase blood flow if necessary. Then dry your hands
and the test site thoroughly. Make sure there is no alcohol, soap, cream or lotion
on the test site.
Clear Cap
Cocking Barrel
Ejection Button
Lancet Holder
Sterile Lancet
Safety Tab
(For testing on forearm and
palm)
Release Button
Fingertip Testing
For fingertip sampling, adjust the depth penetration to reduce the discomfort.
1. Unscrew the lancing device cover from the body of the lancing device. Insert a
sterile lancet into the lancing device and push it until the lancet comes to a
complete stop in the lancing device.
Puncture Depth
Settings
22
Lancing Device
Cover
2. Hold the lancet firmly in the lancing device and twist the safety tab of the
lancet until it loosens. Then pull the safety tab off the lancet. Save the safety
tab for lancet disposal.
3. Carefully screw the cover back onto the lancing device. Avoid contact with the
exposed needle. Make sure the cover is fully sealed on the lancing device.
4. Adjust the puncture depth by rotating the lancing device cover. There are a
total of 11 puncture depth settings. To reduce the discomfort, use the lowest
setting that still produces an adequate drop of blood.
Adjustments:
0 - 1.5 for delicate skin
2 - 3.5 for normal skin
4 - 5 for calloused or thick skin
Note: Greater pressure of the lancing device against the finger will also
increase the puncture depth.
5. Pull the cocking barrel back to set the lancing device. You may hear a click
while the release button changes to orange to indicate the lancing device is
now loaded and ready for obtaining a drop of blood.
23
6. Prior to testing, clean your hands with an alcohol wipe or wash your hands
with soap. Use warm water to increase blood flow in your fingers if necessary.
Then dry your hands thoroughly. Massage the hand from the wrist up to the
fingertip a few times to encourage blood flow.
7. Hold the lancing device against the side of the finger to be lanced with the
cover resting on the finger. Push the release button to prick your fingertip. You
should hear a click as the lancing device activates. Gently massage your
finger from the base of the finger to the tip of the finger to obtain the required
blood volume. Avoid smearing the drop of blood.
For the greatest reduction in pain, lance on the sides of the fingertips.
Rotation of sites is recommended. Repeated punctures in the same spot can
make your fingers sore and callused.
Forearm and Palm Testing
The forearm and palm areas have less nerve endings than the fingertip. You may
find that obtaining blood from these sites is less painful than from the fingertip.
The procedure for forearm and palm sampling is different. You need the clear cap
to draw blood from these sites. The clear cap is not adjustable for puncture depth.
IMPORTANT: There are important differences among forearm, palm and fingertip
24
samples that you should know. Important Information about forearm and palm
glucose testing:
You should consult your healthcare professional before choosing to perform
forearm or palm testing.
When blood levels are changing rapidly such as after a meal, insulin dose or
exercise, blood from the fingertips may show these changes more rapidly than
blood from other areas.
Fingertips should be used if testing is within 2 hours of a meal, insulin dose or
exercise and any time you feel glucose levels are changing rapidly.
You should test with the fingertips anytime there is a concern for
hypoglycemia or you suffer from hypoglycemia unawareness.
Please refer to Fingertip Testing to insert the lancet and load the lancing device.
1. Screw the clear cap onto the lancing device.
2. Choose a puncture site on the forearm or palm. Select a soft and fleshy area
of the forearm and palm that is clean and dry, away from bone, and free of
visible veins and hair.
To bring fresh blood to the surface of the puncture site, massage the puncture
site vigorously for a few seconds until you feel it getting warm.
3. Place the lancing device against the puncture site. Press and hold the clear
cap against the puncture site for a few seconds. Press the release button of
the lancing device, but do not immediately lift the lancing device from the
puncture site. Continue to hold the lancing device against the puncture site
until you can confirm a sufficient blood sample has formed.
25
Disposal of the Lancet
1. Unscrew the lancing device cover. Place the safety tab of the lancet on a hard
surface. Then carefully insert the lancet needle into the safety tab.
2. Press the release button to make sure that the lancet is in the extended
position. Slide the ejection button forward to discard the used lancet. Place
the lancing device cover back on the lancing device.
Lancet Precautions
Do not use the lancet if the safety tab is missing or loose when you take the
lancet out of the bag.
Do not use the lancet if the needle is bent.
Use with caution whenever the lancet needle is exposed.
Never share lancets or the lancing device with other people.
In order to reduce the risk of infection from prior use of the instrument, always
use a new, sterile lancet. Do not reuse lancets.
Avoid getting the lancing device or lancets dirty with hand lotion, oils, dirt or
debris.
26
Step 2 – Testing Blood Glucose
Note: Insertion of a new test strip at any time, except while in the data
transfer mode (detailed on page 34) will cause the meter to automatically
enter the test mode.
1. Insert a test strip into the strip port, contact bars end first and facing up, to turn
on the meter and display all the display segments. If the audio option is on,
the meter will beep, signaling the meter is turned on. The display will turn on
briefly with all the icons and segments turned on. Check the display to confirm
that all the display segments turn on with no missing components.
The display will then show only the date and time, with a dash moving across
the display. Check the display to ensure no inappropriate segments or icons
are permanently turned on.
NOT READY NOT READY NOT READY
2. Following this display check, the system will enter the test mode. The display
will show the date and time and the strip icon with the blood sample icon
blinking, to indicate that the test strip is inserted correctly and a drop of blood
can be added. If the test strip has been inserted incorrectly, the meter will not
turn on. The meter is ready for testing when the blinking blood drop and strip
symbol appears. At this time a blood drop can be added.
READY TO TEST
3. Touch the blood sample to the sample tip at the end of the test strip. If the
audio option is turned on, the meter will also beep to indicate the sample is
sufficient and the measurement has started. If you applied a drop of blood, but
do not see the starting of the count down, you may reapply a second drop of
27
blood within 3 seconds.
DO NOT:
Apply sample to the front or back of the test strip.
Smear the blood drop onto the test strip.
Press your finger against the test strip.
4. The meter will count down from 5 to 1 and then display the measurement
results. If the audio option is on, the meter will also beep to indicate that
measurement is complete. Then your blood glucose level will display on the
screen, along with the unit measurement, date, and time of the test.
Blood Glucose results are automatically stored in the memory. When the meal
marker feature is turned off and a test result is displayed, to mark invalid
results and to prevent them from being included in the 7, 14, 30, 60 and
90-day averages, press the ▼and▲ button together, when a pound sign (#)
appear on the display, then press OK button. A pound sign (#) means that the
result will not be included when calculating the 7, 14, 30, 60 and 90-day
averages. If a result is marked by accident, press the ▼and▲ button together
and then press the ▼or▲ to unmark the result. After marking the invalid result,
run the test again with a new test strip.
OR
When the meal marker feature is turned on and a test result is displayed, mark
the result as “before meal”, “after meal”, or invalid.
Press the ▼and▲ button together to display the “before meal marker” symbol,
indicating the result was taken before a meal.
Press the ▼or▲ button again to display the “after meal marker” symbol,
indicating the result was taken after a meal.
28
Press the ▼or▲ button again to display the pound sign (#), indicating an
invalid result.
Press the ▼or▲ button again then none of the above markers will be
displayed for the result.
After deciding the selection, press the OK to confirm the selection as either
“before meal marker”, “after meal marker”,“invalid result” with pound sign (#)
or none of these three symbols. If an invalid result is marked, run the test
again with a new test strip.
OR
OR
OR
If an error message appears on the display, refer to the Troubleshooting
Guide on page 40. If a “HI” or “LO” error appears on the display, refer to “HI”
and “LO” messages below.
5. After inspection, record valid results in your logbook with the date and time,
and compare them to the target goals set by your diabetes healthcare
professional. Refer to Suggested Testing Times and Target Goals on page
38 for more details on your target blood glucose concentration goals.
6. Slide forward the strip ejector to discard the used test strip.
29
Note: Dispose of blood samples and materials carefully. Treat all blood
samples as if they are infectious materials. Follow proper precautions and
obey all local regulations when disposing of blood samples and materials.
“HI” and “LO” Messages
The meter can accurately measure blood glucose concentrations between 0.6 to
33.3 mmol/L (10 to 600 mg/dL). “HI” and “LO” messages indicate results outside
of this range.
If “HI” appears on the display, the measured concentration value is above
33.3 mmol/L (600 mg/dL). The test should be retaken to ensure that no mistake
was made in the procedure. If you are certain the meter is functioning properly
and no mistakes were made in the procedure, and your blood glucose is still
consistently measured as “HI”, it indicates severe hyperglycemia (high blood
glucose). You should contact your healthcare professional immediately.
If “LO” appears on the display, the measured concentration value is below
0.6 mmol/L (10 mg/dL). The test should be retaken to ensure that no mistake was
made in the procedure. If you are certain the meter is functioning properly and no
mistakes were made in the procedure, and your blood glucose is still consistently
measured as “LO”, it may indicate severe hypoglycemia (low blood glucose). You
should treat yourself for hypoglycemia immediately as recommended by your
healthcare professional.
“Hypo” and “Hyper” Messages
If “Hypo” appears on the display, the measured concentration value is below the
“Hypo” (low blood sugar) target level that you have set.
30
OR
If “Hyper” appears on the display, the measured concentration value is above the
“Hyper” (high blood sugar) target level that you have set.
OR
“Ketone” Message
If “Ketone?” appears on the display, the measured concentration value is above
16.7 mmol/L (300 mg/dL). This simply suggests that a ketone test is
recommended. Consult your healthcare professional about testing for ketones.
OR
Precautions and Limitations
Please refer to the test strip insert.
31
Using the Meter Memory
The meter automatically stores up to 1000 test records. Each record includes the
test result, time and date. If there are already 1000 records in memory, the oldest
record will be erased to make room for a new one.
The meter will also calculate the average values of records from the last 7, 14, 30,
60 and 90 days.
Viewing Stored Records
To view stored records:
1. Press the ▼ button to turn the meter on and enter memory mode. The most
recent value and the word “MEM” will appear on the display.
OR
2. If you are using the meter for the very first time, the meter display will show
three dashed lines (- - -), the word “MEM” and the unit of measure. This shows
that no data have been stored in memory.
3. The date and time will be displayed together with the results stored in memory.
A pound sign (#) indicates records that will be omitted from the 7, 14, 30, 60
and 90-day averages.
4. Press the ▼or ▲ button to view the previous or next stored records.
Press the OK button to view the data averages. The words “DAY AVG” will
appear on the screen.
Note: If you do not wish to view your average glucose measurements, you
can press the ▼ button to return to see stored records, or press OK button
again to turn off the display.
32
5. While in data average mode:
If the meal marker feature is off, press the ▲ button to switch between the
general 7, 14, 30, 60 and 90-day averages.
If the meal marker feature is on, press the ▲ button to switch between the
general, pre-meal and post-meal 7, 14, 30, 60 and 90-day averages.
The meter will calculate the average that you selected. The number of
records used in the DAY AVG will also appear in the display.
Note: Only test results that have been marked as “before meal” or “after
meal” are included in pre-meal and post-meal averages. All blood glucose
results are included in the general 7, 14, 30, 60 and 90-day averages.
OR
6. If there are fewer than 7, 14, 30, 60 and 90 days in memory, all the readings
without the pound (#) sign currently stored in memory will be averaged.
7. If you are using the meter for the very first time, no value will appear on the
display. This means that no records have been stored in memory. If you have
not marked any results as “before meal” or “after meal”, no value will appear
on the display for the pre-meal or post-meal averages. This means that no
records have been stored as “before meal” or “after meal” in memory.
8. Press the OK button to turn off the display.
Note: Results from quality control tests will not be included in the averages.
When viewing results in memory, these values are marked with a pound sign
(#) to show that they will not be included in the 7, 14, 30, 60 and 90-day
averages.
33
Clearing the Memory
Take extreme caution when clearing the memory. This is not a reversible
operation. To clear the memory:
1. With the meter off, press and hold the ▼ button for two seconds. This will turn
on the meter and enter the delete mode.
2. To clear the memory, press and hold both the ▼ and ▲ buttons together for
two seconds.
3. The display will show “MEM” and “---”, the meter will clear its memory and turn
itself off after a moment.
4. If you entered the delete mode but want to exit without deleting the recorded
data, press the OK button. This will turn the meter off without deleting any
data.
Transferring Records
The meter can transfer stored information to a Windows-based personal
computer (PC) using an optional data transfer cable and software package. To
make use of this feature, you need the GIMA Diabetes Management Software
and a data transfer cable from GIMA.
1. Install the software to your personal computer (PC) according to the
instructions from the GIMA Diabetes Management Software Kit.
2. Connect the USB cable to your PC and plug the audio jack of the cable into
the meter data port. Meter will automatically turn itself into “PC” mode.
34
Notes:
When strip is already inserted into the meter and meter is in the waiting for
sample application mode, at this point if data transfer cable is plugged into
meter data port then meter gives E-12 error message and does not
automatically turn to “PC” mode.
When meter is in “PC” mode, meter does not turn to waiting for sample
application mode after strip is inserted into meter.
3. Run the GIMA Diabetes Management Software, and refer to the instructions
from the software for how to transfer records.
4. During the data transfer, the meter will display “to” and “PC”. This indicates the
data is being transferred from the meter to the PC.
5. Once the data transfer is complete, the meter will display “End” and “PC”.
6. After data transfer from meter to PC is completed, press the OK button to turn
off the meter. If nothing else happens to meter 2 minutes after data transfer
from meter to PC is completed, the meter will automatically turn off. In this
case press both the ▼ or ▲ buttons to enter “PC” mode again.
Note: Peripheral equipment such as computer which is intended to be
connected with meter shall conform to relevant safety standard.
See the package insert included with your GIMA Diabetes Management Software
Kit for detailed instructions.
35
Maintenance
Proper maintenance is recommended for best results.
Replacing the Battery
Your GIMA Meter uses two 3.0 Volt CR 2032 lithium batteries.
When the battery icon (
You should replace the battery as soon as possible. An “E-6” error message will
appear if the battery is too low to perform any more blood glucose tests. The
meter will not function until the battery is replaced.
Note: Make sure to replace the used up batteries with two new ones.
Instructions:
1. Turn the meter off before removing the batteries.
2. Turn the meter over to locate the battery cover. Slide the battery cover in the
direction of the arrow to open it.
3. Remove and discard the old batteries. Insert two new CR 2032 3.0 V coin cell
batteries in the battery carriers. Make sure the plus (+) side facing up.
4. Close the battery cover and make sure that it snaps shut.
5. Recheck and reset the clock setting after battery replacement, if necessary.
To set the meter clock, see Meter Setup Before Testing on page 12.
) is blinking, it means the battery is running low.
Upper battery
Lower battery
36
Caring for Your GIMA Blood Glucose Monitoring System
Blood Glucose Meter
Your GIMA Blood Glucose Meter does not require special maintenance or
cleaning. A cloth dampened with water and a mild detergent solution can be used
to wipe the outside of the meter. Take care to avoid getting liquids, dirt, blood or
control solution into the meter through the strip or data ports. It is recommended
that you store the meter in the carrying case after each use.
The GIMA Blood Glucose Meter is a precision electronic instrument. Please
handle it with care.
Lancing Device
Use mild soap and warm water to clean with a soft cloth as required. Carefully dry
the device thoroughly. Do not immerse the lancing device.
Please refer to the lancing device insert for more details.
37
Suggested Testing Times and Target Goals
Tracking your blood glucose concentration through frequent testing is an important
part of proper diabetes care. Your healthcare professional will help you to decide the
normal target range for your glucose levels. They will also help you to determine
when and how often to test your blood glucose. Some suggested times are:
When you wake up (fasting level)
Before breakfast
1-2 hours after breakfast
Before lunch
1-2 hours after lunch
Before or after exercise
Before dinner
1-2 hours after dinner
Before bedtime
After a snack
At 2 or 3 AM, if taking insulin
You may need to test more often whenever1:
You add or adjust your medication for diabetes.
You think your blood glucose levels may be too low or too high.
You are ill, or feeling uncomfortable over long periods of time.
Expected blood glucose levels for people without diabetes2:
Time Range, mg/dL Range, mmol/L
Fasting and Before Meals 70 - 100 3.9 - 5.6
2 Hours after Meals Less than 140 Less than 7.8
Talk to your healthcare professional to set your own daily target ranges.
Time of Day Your Target Range
Waking up (Fasting level)
Before meals
2 hours after meals
Bedtime
2 AM to 3 AM
Other
Use the logbook to record your blood glucose measurements and related
information. Bring the logbook with you when you visit your doctor so that you can
determine how well your blood glucose is being controlled. This can help you and
your healthcare professional make the best decisions about your glucose control
plan.
(Note: 1 mmol/L = 18 mg/dL)
1. Jennifer Mayfield and Stephen Havas, “Self-Control: A Physician’s Guide to Blood Glucose
Monitoring in the Management of Diabetes – An American Family Physician Monograph”
2. ADA Clinical Practice Recommendations, 2018.
38
Comparing Meter and Laboratory Results
Your GIMA Blood Glucose System and laboratory results both report the glucose
concentration in the serum or plasma component of your blood. However, the
results may differ somewhat due to normal variation. The meter results can be
affected by factors and conditions that do not affect laboratory results in the same
way. See GIMA Test Strip package insert for typical accuracy and precision data,
and for important information on Limitations.
To ensure a reasonable comparison, follow these guidelines.
Before you go to the lab:
Bring your meter, test strips and control solution with you to the lab.
Make sure your meter is clean.
Perform a quality control test to make sure the meter is working properly.
Comparisons will be more accurate if you do not eat for at least four hours
(preferably eight hours) before testing.
At the lab:
Wash your hands before obtaining a blood sample.
Obtain blood samples for a laboratory test and for your meter within 10
minutes of each other. This will ensure an accurate comparison of results.
Never use your meter with blood that has been placed in test tubes containing
fluoride or other anticoagulants. This will cause falsely low results.
39
Troubleshooting Guide
The meter has built-in messages to alert you of problems. When error messages
appear, note the error number, turn off the meter and then follow these
instructions.
Display Causes Solution
Meter fails to
turn on
Battery may be damaged or
not be charged
Meter is too cold
Power On self check error
Internal calibration check
error
Test strip was removed during
the test
Sample was applied to the
test strip too soon
Test strip is contaminated or
used
Sample was applied to the
test strip too soon
Insufficient sample
Sample application error due
to late sample re-dosing
Replace battery.
If meter has been exposed to or stored
in cold conditions, wait 30 minutes to
allow the meter to reach room
temperature then repeat the test.
Remove the batteries for 30 seconds
and then put them back and turn meter
on again.
If the problem persists, please contact
your local distributor.
Turn off meter or remove test strip, and
then turn on meter again to retest.
If the problem persists, please contact
your local distributor.
Repeat the test and ensure test strip
remains in place.
Repeat test and apply sample after
blood drop/test strip symbol appears.
Repeat test with a new test strip.
Repeat test and apply sample after
blood drop/test strip symbol appears.
Repeat the test and apply enough
sample to fill the test strip check
window.
Repeat the test and apply enough
sample to fill the test strip check window
within 3 seconds.
40
Display Causes Solution
Temperature has exceeded
the operating temperature of
the system
Temperature is below the
operating temperature of the
system
Battery is discharged but has
enough power to run 20 more
tests
Battery is discharged and
meter does not allow more
tests until replacement with a
new battery
Meter electronics failure
Move to a cooler environment and
repeat the test.
Move to a warmer environment and
repeat the test.
Test results will still be accurate, but
replace the two batteries as soon as
possible.
Replace the two batteries and repeat
the test.
If the problem persists, please contact
your local distributor.
Damaged test strip or
calibration error
Communications failure
Strip testing error
Sample Perturbation
Meter data port is plugged in
with data transfer cable when
meter is in waiting for sample
application mode with strip
already inserted into the
meter strip port
Please test again by using a new strip.
If the problem persists, please contact
your local distributor.
There is an error in transferring data to
the PC. See the package insert included
in the GIMA Diabetes Management
Software for troubleshooting.
Repeat the test and apply enough
sample to fill the test strip check window
within 3 seconds. When repeat testing,
do not touch the strip during meter count
down. Please make sure fresh blood
sample with intended hematocrit level is
used. Please make sure blood sample
is not contaminated.
If the problem persists, please contact
your local distributor.
Unplug the data transfer cable from the
meter’s data port. Then remove the
strip. Reinsert the strip into the strip port
for testing.
If the problem persists, please contact
your local distributor.
41
Specifications
Feature Specification
Meter Model Number OGM-211
Measurement Range 0.6 - 33.3 mmol/L (10 – 600 mg/dL)
Data Port 9600 baud, 8 data bits, 1 stop bit, no parity
42
Warranty
Please complete the warranty card that came with this product and mail it to your
local distributor to register your purchase.
If the meter fails to work for any reason other than obvious abuse within the first
five (5) years from purchase, we will replace it with a new meter free of charge.
For your records, also write the purchase date of your product here.
Date of purchase: __________________________________________________
Note: This warranty applies only to the meter in the original purchase, and does
not apply to the battery supplied with the meter.
43
IVD
LOT
CTRL
REF
SN
MODEL
Index of Symbols
Consult instructions for use
In vitro diagnostic medical device
Temperature limit
Contains sufficient for <n> tests
Use by
Lot Number
Manufacturer
Authorized representative in the European Community
Sterilized using irradiation
Control Range
Catalogue number
Serial Number
Model Number
Do not dispose along with household waste
Do not reuse
Humidity limitation
Atmospheric pressure limitation
Direct current
Data transmission port
44
Index
…
…
…
…
.
.
.
.
…
…
…
.
…
…
…
…
…
…
.
…
…
…
…
Averaging Results……………..32Set the Clock………………….12
Battery, Replacing the ………
Carrying Case…………………
Clearing the Memory…………
Data Port...................................3,4Precautions and Limitations31
Date Format..............................8,10Testing Your Blood…………
Guidelines................................
Hematocrit................................
Hyperglycemia.........................
Hypoglycemia..........................
Ketones………………..………
Lancing Device………………
Lancets…………………………
Maintenance.............................
Measure, Unit of………………
Meter……………………………
Audio feature………………....14 Symbols, Index of……………44
Cleaning………………….…
Display………………………
Error Messages……………
"HI" and "LO" Messages……
▼ Button……………………
Memory………………………
Meter Use and Precautions
Meter Setup…………………
OK Button…………………….3 Warranty………………………… 2,43
▲Button………………………3
36Specifications…………………42
1Strip ejector……………………3,29
34 Procedure
22
I Quality Control Test…………19
42Control Solution……………9
14,30How to Run……………………19
15,30 Results
14,31Blood Glucose………………28
1,22,37Control Solution……………… 9,20
1,22Meter vs. Lab Results…….…39
6,36Target Goals………………….38
5,20Unit of Measure……………….20,38
3 Suggested Testing Times……38
37 Test Strip………………………7
5Expiration……………………..8
40,41Precautions…………………
30 Testing Your Blood…………….22
3Get a Drop of Blood…………22
32Test Blood Glucose………….27
6 Troubleshooting………………. 40,41
12 Viewing Stored Records………32
45
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