Fora V30a Read Before Use

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Dear System Owner:
Thank you for purchasing the FORA V30a Blood Glucose Monitoring System. This manual provides important information to help you to use the system properly. Before using this product, please read the following contents thoroughly and carefully.
an use the FORA V30a Blood Glucose Monitoring System to easily monitor your blood glucose levels by yourself anywhere, any time.
If you have other questions regarding this product, please contact the place of purchase.
V30a
Version 1.0 2010/07 311-4242100-007
English
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IMPORTANT SAFTY INSTRUCTIONS
READ BEFORE USE
1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories which are not specied by the manufacturer.
3. Do NOT use the device if it is not working properly or if it is damaged.
4. Do NOT use the equipment in places where aerosol sprays are being used or where oxygen is being administered.
5. Do NOT use under any circumstances on neonates.
6. This device does NOT s
erve as a cure for any symptoms or diseases. The data measured is for reference only. Always consult your doctor to have the results interpreted.
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7. Before using this device to test blood glucose, read all instructions thoroughly and practice the test. Carry out all the quality control checks as directed.
8. Keep the device and testing equipment away from young children. Small items such as the battery cover, batteries, test strips, lancets and vial caps are choking hazards.
9. Use of this instrument in a dry environment, especia
lly if synthetic materials are present (synthetic clothing, carpets etc.) may cause damaging static discharges that may cause erroneous results.
10.Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
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TABLE OF CONTENTS
BEFORE YOU BEGIN 06
Important Information 06
Intended Use 07
Test Principle 07
Contents of System 08
Meter Overview 09
Display Screen 10
Test Strip 11
Speaking Function 12
Setting the Meter 13
THE FOUR MEASURING MODES 18
BEFORE TESTING 20
Control Solution Testing 20
Performing a Control Solution Test 21
TESTING WITH BLOOD SAMPLE 24
Overview of the Lancing Device 24
Setting up the Lancing Device 24
Preparing the Puncture Site 27
Alternative Site Testing 29
Performing a Blood Gluc
ose Test 31
METER MEMORY 34
Reviewing Test Results 34
Reviewing Blood Glucose Day Average Results 36
Downloading Results onto a Computer 39
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MAINTENANCE 41
Battery 41
Caring for Your Meter 43
Caring for Your Test Strips 44
Important Control Solution Information 45
SYSTEM TROUBLESHOOTING 46
Result Readings 46
Error Messages 47
Troubleshooting 49
DETAILED INFORMATION 51
Reference Values 51
Comparing Meter and Laboratory Results 52
SPECIFICATIONS 54
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BEFORE YOU BEGIN
Important Information
Severe dehydration and excessive water loss may cause readings which are lower than actual values. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.
If your blood glucose results are lower or higher than usual, and you do not have any symptoms of illness, rst repeat the test. If you have symptoms or co
ntinue to get results which are higher or lower than usual, follow the treatment advice of your healthcare professional.
Use only fresh whole blood samples to test your blood glucose. Using other substances will lead to incorrect results.
If you are experiencing symptoms that are inconsistent with your blood glucose test results and you have followed all the instructions given in th
is owner’s manual, contact your healthcare professional.
We do not recommend using this product on severely hypotensive individuals or patients in shock. Readings which are lower than actual values may occur for individuals experiencing a hyperglycaemic-hyperosmolar state, with or without ketosis. Please consult the healthcare professional before use.
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Intended Use
This system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and by health care professionals in clinical settings as an aid to monitoring the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh whole blood samples (from the nger, palm, forearm, upper arm, calf and thigh).
This
system is not intended for the diagnosis of or screening for diabetes and is not intended to be used on neonates. Alternative site testing (AST) in this system can be used only during steady-state blood glucose conditions described in the section “about AST”.
This meter has some speaking functions but is not intended for use by the visually impaired.
Test Principle
Your system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.
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Contents of System
Your new FORA V30a system kit includes:
Test strips, control solutions (high and normal) and lancets are op­tional. They are not included in the kit (please check the contents on your product box). They can be purchased separately.
NOTE
If any items are missing from your kit or opened prior to use, please contact
local customer services or place of purchase for assistance.
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1
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4
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3
7
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2
2
Warranty Card 2X1.5V AAA alkaline batteries
Meter Owner’s Manual Protective Wallet Quick Start User Guide Daily Log Book
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Meter Overview
Front Side Back
Test Slot
Insert test strip here to turn the meter on for testing.
Display Screen M Button
Enter the meter memory and silence a reminder alarm
Test Strip Ejector
Eject the used strip by push­ing up this button.
1
3
4
2
Data Port
Download test results with a cable connection.
SET Button
Enter and conrm the meter settings.
C Button
Marks a control solution test.
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7
6
1
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2
4
5
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10
Display Screen
Low Battery Symbol Test Strip Symbol Blood Drop Symbol Volume Symbol Test Result Memory Symbol Alarm Function Indicator Measuring Mode
Date Time Ketone Warning Day Average Measurement Unit Error Control Solution Mode
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6
4
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5
3
2
13
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10
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14 3 2
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5
10
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Test Strip
NOTE
The FORA V30a meter should only be used with FORA V30a Test Strips.
Using other test strips with this meter can produce inaccurate results.
Absorbent Hole
Apply a drop of blood here. The blood will be
automatically absorbed.
Conrmation Window
This is where you conrm if enough blood has been applied to the absorbent
hole in the strip.
Test Strip Handle
Hold this part to insert the
test strip into the slot.
Contact Bars
Insert this end of the test strip into the meter. Push it in rmly until it will go no
further.
ATTENTION: Test results might be wrong if the contact bar is not fully inserted into the test slot.
The front side of the test strip should face up when inserting the test strip.
Front Back
1
4
3
2
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Speaking Function
FORA V30a “speaks” aloud step by step instructions to guide you through the process of blood glucose testing. The following table tells you when and what the meter “speaks”.
WHEN does the meter say? WHAT does the meter say?
When turning on the meter
Thank you for using this product. Please relax during measure­ment.
When room temperature is out­side operating range, which is 50ºF to 104ºF (10ºC to 40ºC).
Room temperature out of range, unable to measure.
After inserting test strip.
Please apply blood onto the test strip.
When the meter is ready to test. (Symbol appears on display)
When
the test is completed.
(Result appears on display)
The blood glucose is (number) milligrams per decilitre.
When the test result is outside measurement range, which is 20 to 600 mg/dL (1.1 to 33.3 mmol/L).
The blood glucose is out of range, unable to measure.
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Setting the Meter
Before using your meter for the rst time or if you change the meter battery, you should check and update these settings. Make sure you complete the steps below and have your desired settings saved.
► Entering the Setting Mode.
Start with the meter off (no test strip inserted). Press SET to turn on the meter.
Step 1
Setting the date.
With the year ashing, press
until the
correct year appears. Press SET.
With the month ashing, press
until the
correct month appears. Press SET.
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With the day ashing, press
until
the correct day appears. Press SET.
Step 2
Setting the time format.
Press and release
to select the desired time format --- 12h or 24h. Press SET.
Step 3
Setting the time.
With the hour ashing, press
until
the correct hour appears. Press SET.
With the minute ashing, press
until
the correct minute appears. Press SET.
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Step 4
Deleting the memory.
With “dEL” and “
” symbol on the display, press
and select “no”
to keep the results in memory then press SET to skip.
To delete all the results, press
and select “YES”. Then press SET to delete all memory. “OK” is displayed in the meter, which indicates that all data stored is deleted.
Step 5
Setting the Speaking Volume.
There are seven (7) speaking volume op­tions to choose from. Press
to choose a volume from 0 to 7. To conrm your selec­tion, press SET. Volume 0 indicates that the speaking func­tion is turned off, and “
” will not display during testing. Volume 1 to 7 indicates speaking volume from low to high, and “ ”
will be displayed throughout the testing.
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Step 7
Setting the reminder alarm.
You may set up any or all of the reminder alarms (1-4). The meter displays “On” or “OFF” and “
, press
to turn on or turn off to
set the rst reminder alarm.
Press
to select “On”, then press SET to set the hour. When the
hour is ashing, press
to add an hour. Press SET to conrm and go
to minutes, press
to add one minute. Hold
longer to add faster.
Press SET to conrm and go to the next alarm setting.
Step 6
Choosing a Language.
Press
to select L1/L2.The default language for the meter is L1,
which is English. To conrm your selection, press SET.
If you do not want to set an alarm, press SET to skip this step.
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If you want to turn off an alarm, nd the alarm number by pressing SET in the setting mode, press
to change from “ON’ to “OFF”.
At the time of your alarm, the meter will beep and automatically turn on. You can press
to silence the alarm and insert a test strip to
begin testing. If you do not press
, the meter will beep for 2 minutes then switch off. If you do not want to test at this time, press
to switch off the meter.
Congratulations! You have completed all settings!
NOTE
These parameters can ONLY be changed in the setting mode.
If the meter is idle for 3 minutes during the setting mode, it will switch off
automatically.
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THE FOUR MEASURING MODES
The meter provides you with four modes for measuring, General, AC, PC and QC.
MODES USE WHEN
any time of day without regard to time since last meal
no food intake for at least 8 hours
2 hours after a meal
testing with the control solution
You can switch between each mode by:
Step 1
Start with the meter switched off. Insert a test strip to turn on the meter. The screen will display a ashing blood drop and “Gen”.
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Step 2
Press
to switch between General, AC,and PC mode.
Step 3
Press
to switch to QC mode.
NOTE
AC and PC results are NOT included in the general day average results.
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BEFORE TESTING
Control Solution Testing
FORA Control Solution contains a known amount of glucose that reacts with test strips and is used to ensure your meter and test strips are working together correctly.
Do a control solution test when:
you rst receive the meter,
at least once a week to routinely check the meter and test strips,
you begin using a new vial of test strips,
you suspect the meter or test strips are not working properly,
your blood glucose test results are not consistent with how you feel,
or if you think the results are not accurate,
practicing the testing process, or
you have dropped or think you may have damaged the meter.
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Performing a Control Solution Test
Step 1
Insert the test strip to turn on the meter.
Insert the test strip into the meter. Wait for the meter to display the test strip and blood drop symbols.
Step 2
Press
to mark this test as a control solution test.
If you press
again, the “QC” will disappear and this test is no longer
a control solution test.
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Step 3
Apply control solution.
Shake the control solution vial thoroughly before use. Squeeze out a drop and wipe it off, then squeeze out another drop and place it on the tip of the vial cap.
Hold the meter to move the absorbent hole of the test strip to touch the drop. Once the conrmation window lls completely, the meter will begin counting down.
To avoid contaminating the control solution do not directly apply control solu
tion onto a strip.
Step 4
Read and compare the result.
After counting down to 0, the control solution test result will appear on the display. Compare this result with the range printed on the test strip vial and it should fall within this range. If not, please read the instructions again and repeat the control solution test.
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Out-of-range results.
If you continue to have test results fall outside the range printed on the test strip vial, the meter and strips may not be working properly. Do NOT test your blood. Contact the local customer service or place of purchase for help.
NOTE
The control solution range printed on the test strip vial is for control
solution use only. It is not a recommended range for your blood glucose
level.
See the Maintenance section for important information about your
control solutions.
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TESTING WITH BLOOD SAMPLE
Overview of the Lancing Device
If your lancing device differs from the one shown here, please refer to the manufacturer’s manual to ensure proper usage.
NOTE
To reduce the chance of infection:
Never share a lancet or the lancing device.
Always use a new, sterile lancet. Lancets are for single use only.
Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the
lancing device.
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3 4
5 76
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Cap Adjustable Tip Depth Indicator Arrow
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3
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Lancet Holder Ejector Release Button Cocking Control
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A Clear Cap
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Setting up the Lancing Device
Step 1
Pull off the cap of the lancing device.
Step 2
Insert a lancet into the lancet holder and push down rmly until it is fully secured.
Step 3
Twist the protective disk off the lancet.
Step 4
Replace the cap by aligning the arrow on the cap with the release button.
Step 5
Select the depth of penetration by turning the adjustable tip in either direction so that the arrow on the cap points to the desired depth.
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The lancing device is now ready for use. Set aside for later use.
Step 6
Pull the cocking control back until it clicks. You will see a color change inside the release button when it is ready.
If it does not click, the device may have been cocked when the lancet was inserted.
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Preparing the Puncture Site
Stimulating blood perfusion by rubbing the puncture site before blood extraction has a signicant inuence on the glucose value obtained. Blood from a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the nger. When the puncture site was rubbed prior to blood extraction, the difference was signicantly reduced.
Please follow the suggestions below before obtaining a drop of blood:
Wash a
nd dry your hands before starting.
Select the puncture site either at ngertips or another body parts (please see section “Alternative Site Testing” (AST) on how to select the appropriate sites).
Clean the puncture site using cotton moistened with 70% alcohol and let it air dry.
Rub the puncture site for about 20 seconds before penetration.
Use a clear cap (included in the kit) while setting
up the lancing
device.
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► Fingertip Testing
Press the lancing device’s tip rmly against the lower side of your ngertip. Press the release button to prick your nger, then a click indicates that the puncture is complete.
► Blood from Sites Other Than the Fingertip
Replace the lancing device cap with the clear cap for AST. Pull the cocking control back until it clicks. When lancing the forearm, upper arm, hand, thigh, or calf, avoid lancing the areas with obvious veins because of ex
cessive
bleeding.
NOTE
Choose a different spot each time you test. Repeated punctures at the
same spot may cause soreness and calluses.
Please consult your health care professional before you begin AST.
It is recommended to discard the first drop of blood as it might contain
tissue uid, which may affect the test result.
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Alternative Site Testing
Important: There are limitations with AST (Alternative Site Testing).
Please consult your health care professional before you perform
AST.
What is AST?
Alternative site testing (AST) means that people use parts of the body other than the ngertips to check their blood glucose levels. This system allows you to test on the palm, the forearm, the upper arm, the calf or the thigh with results equivalent to ngertip testing.
What is the advantage?
Fingertips feel pain more readily because they are full of nerve endings (receptors). At other body
sites, since nerve endings are not so condensed, you will not feel as much pain as on the ngertips.
When to use AST?
Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood at the ngertip reects these changes faster than capillary blood at other sites. Thus, when testing blood glucose during or immediately after a meal, physical exercise, or any other event, take a blood sample from your nger only.
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We strongly recommend that you perform AST ONLY at the following times:
In a pre-meal or fasting state (more than 2 hours since the last meal).
Two hours or more after taking insulin.
Two hours or more after exercise.
Do NOT use AST if:
You think your blood glucose is low.
You often do not notice when your blood glucose is low.
You think your blood glucose is high.
Your AST results do not m
atch the way you feel.
Your routine glucose results are often uctuate.
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Performing a Blood Glucose Test
Step 1
Insert the test strip to turn on the meter.
Wait for the meter to display the test strip “
” and blood drop “ ”
symbol.
Step 2
Select the appropriate measuring mode by pressing
.
For selecting the measuring mode, please refer to the “FOUR MEASURING MODES” section on page 18.
Step 3
Obtaining a blood sample.
Use the pre-set lancing device to puncture the desired site. After penetration, discard the rst drop of blood with a clean cotton swab. Gently squeeze the punctured area to obtain another drop of blood. Be careful NOT to smear the blood sample.
The volume of blood sample must be at least 0.5 microli
ter (μL) of volume. ( actual size).
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Step 4
Apply the sample.
Hold the blood drop to touch the absorbent hole of the test strip. Blood will be drawn in and after the conrmation window is completely lled, the meter begins counting down.
NOTE
Do not press the punctured site against the test strip or try to smear the
blood.
If you do not apply a blood sample to the test strip within 3 minutes, the
meter will automatically turn off. You must remove and reinsert the test
strip to start a new test.
The conrmation window should be lled with blood before the meter
begins to count down. NEVER try to add more blood to the test strip
after
the drop of blood has moved away. Discard the used test strip and retest
with a new one.
If you have trouble lling the conrmation window, please contact your
health care professional or the local customer service for assistance.
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Step 5
Read your result.
The result of your blood glucose test will appear af­ter the meter counts down to 0. This blood glucose result will automatically be stored in the memory.
Step 6
Eject the used test strip and remove the lancet.
To eject the test strip, point the strip at a disposal container for sharp items. The meter will switch itself off automatically after the test strip is ejected.
Step 7
Always follow the instructions in the lancing device insert when
removing the lancet.
WARNING!
The used lancet and test strip may be biohazards. Please discard them
carefully according to the recommendations of your healthcare provider.
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METER MEMORY
The meter stores the 450 most recent blood glucose test results along with respective dates and times in its memory. To enter the meter memory, start with the meter switched off.
Reviewing Test Results
Step 1
Press
.
”will appear on the display. Press
again, and the rst reading you see is the last blood glucose result along with date, time and the measuring mode.
Step 2
Press
to recall the test results stored in the meter each time you press.
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Step 3
Exit the meter memory.
After the last test results, press
again and the meter will be turned
off.
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Reviewing Blood Glucose Day Average Results
Step 1
Press
.
When “
” appears on the display, keep pressing
for 3 seconds
until the ashing
appears. Release
and then your 7-day
average result measured in general mode will appear on the display.
Step 2
Press
to review 14-, 21-, 28-, 60- and 90- day average results
stored in each measuring mode in the order of Gen, AC, then PC.
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Step 3
Exit the meter memory.
Keep pressing
and the meter will turn off after displaying the last
test result.
NOTE
Any time you wish to exit the memory, keep pressing
for 5 seconds or
leave it without any action for 3 minutes. The meter will switch off
automatically.
Control solution results are NOT included in the day average.
If using the meter for the first time, “---” displays when you recall the test
results or review the average result. It indicates that there is no test result
in the memory.
AC and PC results are NOT included in the general day
average results.
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Step 1
Obtaining the required cable and installing the software.
To download the Health Care Software System, please visit the Fora Care Inc, website at www.foracare.com/usa.
Step 2
Connecting to a personal computer.
Connect the cable to a serial port on your computer. With the meter switched off, connect the other end of the interface cable to the me­ter data port. “PC” will appear on the meter display, indicating that the meter is in communication mode.
Downloading Results onto a Computer
You can use the meter with an interface cable and the Health Care Software System to view your test results on your personal computer. To learn more about the Health Care Software System or to obtain an interface cable separately, please contact local customer services or the place of purchase for assistance.
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Step 3
Data transmission.
To transmit data, follow the instructions provided with the software. Results will be transmitted with date and time. Remove the cable and the meter will automatically switch off.
WARNING!
While the meter is connecting to the PC, it will be unable to perform a blood
glucose test.
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MAINTENANCE
Battery
Your meter comes with two 1.5V AAA size alkaline batteries.
► Low Battery Signal
The “
” symbol appears along with
display messages: The meter is functional and the result remains accurate, but it is time to change the battery.
The “
” symbol appears with E-b,
Error and low:
The power is not enough to do a test. Please change the battery immediately.
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► Replacing the Battery To replace the battery, make sure that the meter is turned off.
Step 1
Press the edge of the battery cover and lift it up to remove.
Step 2
Remove the old batteries and replace with two 1.5V AAA alkaline batteries.
Step 3
Close the battery cover. If the batteries are inserted correctly, you will hear a “beep” afterwards.
NOTE
Replacing the batteries does not affect the test results stored in the
memory.
As with all small batteries, these batteries should be kept away from small
children. If swallowed, promptly seek medical assistance.
Batteries might leak chemicals if unused for a long time. Remove the
batteries if you are not going to use the device for an extended period (i.e.,
3 months or more).
Proper
ly dispose of the battery according to your local environmental
regulations.
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Caring for Your Meter
To avoid the meter and test strips attracting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use.
► Cleaning
To clean the meter exterior, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft and dry cloth. Do NOT rinse with water.
Do NOT use organic solvents to clean the meter.
► Meter Storage
Storage condition
s: -4°F to 140°F (-20°C to 60°C), below 95%
relative humidity.
Always store or transport the meter in its original storage case.
Avoid dropping and heavy impact.
Avoid direct sunlight and high humidity.
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Caring for Your Test Strips
Storage conditions: 39.2°F to 104°F (4°C to 40°C), below 85% relative humidity. Do NOT freeze.
Store your test strips in their original vial only. Do not transfer to another container.
Store test strip packages in a cool and dry place. Keep away from direct sunlight and heat.
After removing a test strip from the vial, immediately close the vial cap tightly.
Touch the test strip with clean and dry hands.
Use each test strip immediately after removing it from the vial.
Write the opening date on the vial label when you rst opened it.
Discard remaining test strips after 3 months.
Do not use test strips beyond the expiry date. This may cause inaccurate results.
Do not bend, cut, or alter a test strip in any way.
Keep the strip vial away from
children since the cap and the test strip may be a choking hazard. If swallowed, promptly see a doctor for help.
For further information, please refer to the test strip package insert.
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Important Control Solution Information
Use only FORA control solutions with your meter.
Do not use the control solution beyond the expiry date or 3
months after rst opening. Write the opening date on the control solution vial and discard the remaining solution after 3 months.
It is recommended that the control solution test be done at room temperature (68°F to 77°F / 20°C to 25°C). Ma
ke sure your control solution, meter, and test strips are at this specied temperature range before testing.
Shake the vial before use, discard the rst drop of control solution, and wipe off the dispenser tip to ensure a pure sample and an accurate result.
Store the control solution tightly closed at temperatures between
35.6°F and 86°F (2°C and 30°C). Do NOT freeze.
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SYSTEM TROUBLESHOOTING
If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call your local customer service. Do not attempt to repair by yourself and never try to disassemble the meter under any circumstances.
Result Readings
APPEARS WHEN GLUCOSE
< 20 mg/dL (1.1mmol/L)
> 600 mg/dL (33.3mmol/L)
240 mg/dL (13.3 mmol/L)
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Error Messages
MESSAGE WHAT IT
MEANS
WHAT DOES
METER SAY?
WHAT TO DO
Appears when the batteries cannot provide enough power for a test.
Battery is dead. Please replace.
Replace the bat­teries immedi­ately.
Remove the strip after apply­ing blood to the absorbent hole.
Test strip has been removed during testing.
Appears when a used test strip is inserted.
The test strip has been used. Please replace.
Re-test with a new test strip.
Repeat with a new test strip.
Appears when ambient temperature is below system operation range.
System op­eration range is 50°F to 104°F (10°C to 40°C). Repeat the test after the meter and test strip are in the above tempera­ture range.
Room tem­perature is out of range. Thus unable to measure.
Appears when ambient temperature is above system operation range.
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Problem with the meter.
Repeat the test with a new test strip. If the me­ter still does not work, please contact the customer service for as­sistance.
System error.
MESSAGE WHAT IT
MEANS
WHAT TO DOWHAT DOES
METER SAY?
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Troubleshooting
1. If the meter does not display a message after inserting a test strip:
POSSIBLE CAUSE WHAT TO DO
Replace the batteries.
Insert the test strip with contact bars end rst and facing up.
Please contact customer services.
Batteries exhausted.
Test strip inserted upside down or incompletely.
Defective meter or test strips.
2. If the test does not start after applying the sample:
POSSIBLE CAUSE WHAT TO DO
Repeat the test using a new test strip with larger volume of blood sample.
Repeat the test with a new test strip.
Repeat the test with a new test strip. Apply sample only when ashing
” appears on the
display.
Please contact customer services.
Insufcient blood sample.
Defective test strip.
Sample applied after automatic switch-off (2 minutes after last user action).
Defective meter.
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3. If the control solution testing result is out of range:
POSSIBLE CAUSE WHAT TO DO
Read instructions thoroughly and repeat the test again.
Shake the control solution vigorously and repeat the test again.
Check the expiry date of the control solution.
Control solution, meter, and test strips should be at room temperature (68°F to 77°F / 20°C to 25°C) before testing.
Repeat the test with a new test strip.
Please contact customer services.
Error in performing the test.
Control solution vial was poorly shaken.
Expired or contaminated control solution.
Control solution that is too warm or too cold.
Defective test strip.
Meter malfunction.
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DETAILED INFORMATION
Reference Values
Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that maintaining blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%
*1
. The results provided by this system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.
Source: American Diabetes Association (2008). Clinical Practice
Recommendations. Diabetes Care, 31 (Supplement 1): S1-108.
Please consult your doctor to determine a target range that works
best for you.
References:
*1: American Diabetes Association position statement on the Diabetes Control
and Complications Trial (1993).
Time of day Normal plasma glucose range for people
without diabetes (mg/dL)
< 100 mg/dL (5.6 mmol/L)
< 140 mg/dL (7.8 mmol/L)
Fasting and before meal
2 hours after meals
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Comparing Meter and Laboratory Results
The meter provides you with plasma equivalent results. The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter results may be affected by factors and conditions that do not affect laboratory results in the same way. To make an accurate comparison between meter and laboratory results, follow the guide
lines below
Before going to the lab:
Perform a control solution test to make sure that the meter is working properly.
Fast for at least eight hours before doing comparison tests, if possible.
Take your meter with you to the lab.
While staying at the lab:
Make sure that the samples for both tests are taken and tested within 15 minutes of each other.
Wash your hands before obtaining a blood sample.
Never use your meter with blood that ha
s been collected in a
gray-top test tube.
Use fresh capillary blood only.
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You may still have a variation from the result because blood glucose levels can change signicantly over short periods of time, especially if you have recently eaten, exercised, taken medication or experienced stress
*2
. In addition, if you have eaten recently, the blood glucose level from a nger prick can be up to 70 mg/dL (3.9 mmol/L) higher than blood drawn from a vein (venous sample) used for
a lab test*3. Therefore, it is best to fast for eight hours before doing comparison tests. Factors such as the amount of red blood cells in the blood (a high or low hematocrit) or the loss of body uid (dehydration) may also cause a meter result to be different from a laboratory result.
References:
*2: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 49-51.
*3: Sacks, D.B.: “Carbohydrates. “ Burtis, C.A., and Ashwood, E.R.( ed.), Tietz
Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994),
959.
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SPECIFICATIONS
Model No.: TD-4242
Dimension & Weight: 96(L) x 50(W) x 23(H) mm, 76.15g
Power Source: two 1.5V size AAA alkaline batteries
Display: LCD
Memory: 450 measurement results with respective date and time
External Output: RS232 PC interface
Auto electrode insertion detection Auto sample loading detection Auto reaction time count-down Auto switch-off after 3 minutes without action Temperature Warning
Operating Conditions: 50°F to 104°F (10°C to 40°C), below 85% R.H. (non-condensing)
Storage / Transportation Condition:
-4°F to 14
0°F (-20°C to 60°C), below 95% R.H.
Measurement Units: mg/dL
Measurement Range: 20 to 600mg/dL (1.1 to 33.3mmol/L)
This device has been tested to meet the electrical and safety requirements of: IEC/EN 61010-1, IEC/EN 61010-2-101, IEC/EN 61326-1, IEC/EN 61326-2-6
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