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Monitoring System

ADVANCE

Owner’s
Manual

For self-testing.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
TESTAmed®
GlucoCheck ADVANCE Monitoring System En

Dear TESTAmed GlucoCheck ADVANCE System Owner:


Thank you for purchasing the TESTAmed GlucoCheck ADVANCE 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.

Regular monitoring of your blood glucose levels can help you and your
doctor gain better control of your diabetes. Due to its compact size and
easy operation, you can use the TESTAmed GlucoCheck ADVANCE 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
TESTAmed Customer Hotline.

IMPORTANT SAFETY PRECAUTIONS (READ BEFORE USE)


1. Use this device only for the intended use described in this manual.
2. Do not use accessories which are not specified 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 under any circumstances use the device on newborns or infants.
6. This device does not serve as a cure for any symptoms or diseases.
The data measured is for reference only.
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, especially 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.

i
TABLE OF CONTENTS En

Before you begin ............................................................................. 1


Before you begin ........................................................................... 1
Important Information .................................................................. 1
Intended Use ................................................................................ 2
Test Principle ................................................................................ 2
Meter Overview ............................................................................... 3
Display Screen ................................................................................. 5
Test Strip .......................................................................................... 6
Setting the Meter ............................................................................ 7
The four measuring modes ............................................................ 12
Control Solution Testing ................................................................. 13
Performing a Control Solution Test ............................................... 14
Testing with blood sample ............................................................. 17
Preparing the Puncture Site .......................................................... 17
Alternative Site Testing .................................................................. 18
Performing a Blood Glucose Test .................................................. 20
Meter Memory ................................................................................. 23
Reviewing Test Results ................................................................. 23
Reviewing Blood Glucose Day Average Results .............................. 24
Downloading Results onto a Computer ......................................... 25
Maintenance .................................................................................... 26
Battery .......................................................................................... 26
Caring for Your Meter ................................................................... 28
Caring for Your Test Strips ............................................................ 29
Important Control Solution Information ....................................... 30
System Troubleshooting ................................................................. 31
Result Readings ............................................................................ 31
Error Messages ............................................................................. 32
Troubleshooting ........................................................................... 33
Detailed Information ...................................................................... 36
Symbol Information ........................................................................ 37
Specifications ................................................................................. 38

ii
En BEFORE YOU BEGIN

Before you begin

Important Information
a 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.
a If your blood glucose results are lower or higher than usual, and you
do not have any symptoms of illness, first repeat the test. If you have
symptoms or continue to get results which are higher or lower than usual,
follow the treatment advice of your healthcare professional.
a Use only fresh whole blood samples to test your blood glucose.
Using other substances will lead to incorrect results.
a If you are experiencing symptoms that are inconsistent with your blood
glucose test results and you have followed all the instructions given in this
owner’s manual, contact your healthcare professional.
a 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-hyper-
osmolar state, with or without ketosis. Please consult the healthcare
professional before use.
a The measurement unit used for indicating the concentration
of blood or plasma glucose can either have a weight dimension
(mg/dl) or a molarity (mmol/l).
The approximate calculation rule for conversion of mg/dl in
mmol/l is:

mg/dl Divided by 18 = mmol/l


mmol/l Times 18 = mg/dl

For example;
1) 120 mg/dl ÷ 18 = 6.6 mmol/l
2) 7.2 mmol/l x 18 = 129 mg/dl approximately.

1
BEFORE YOU BEGIN En

Intended Use

a 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 capillary (from the finger, palm, forearm, and upper arm) and
venous blood samples.
a It should not be used for the diagnosis of diabetes, or testing on newborns.
a Professionals may use test strips to test capillary and venous whole blood;
home use is limited to capillary whole blood testing.

Test Principle

a 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.

2
En METER OVERVIEW

Front

4 5

Back

3
METER OVERVIEW En

Side

8 9

1. Strip Indicator Light

2. Display Screen

3. Test Slot: Insert test strip here to turn the meter on for testing.

4. Down Button: Select or change information and adjust


decrement.

5. MAIN Button / Up button: Enter the meter memory and silence


a reminder alarm / Select or change information and adjust
increment.

6. SET Button: Enter and confirm the meter settings.

7. Battery Compartment

8. Test Strip Ejector: Eject the used strip by pushing this button up.

9. USB Slider with Data Port: Download test results via built-in USB.

4
En DISPLAY SCREEN

1 10

2 11

4 12
5

6 13
7
8 14

9 15

1. Blood Drop Symbol 9. Date

2. Volume Symbol 10. Test Strip Symbol

3. Test Result 11. Low Battery Symbol

4. Ketone Warning 12. Measurement Unit

5. Warning Symbol 13. Alarm Symbol

6. Memory Symbol 14. Day average

7. Testing Mode Symbol 15. Time

8. Control Solution Mode

5
TEST STRIP En

Absorbent Hole
Apply a drop of blood here.
The blood will be automatically
absorbed.
Confirmation
Window
This is where you confirm
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 firmly until it
will go no further.

ATTENTION:
The front side of test of test strip should
face up when inserting test strip.
Test results might be wrong if the contact bar is
not fully inserted into the test slot.

NOTE:
The TESTAmed GlucoCheck ADVANCE meter should only be used with
TESTAmed GlucoCheck ADVANCE Test Strips.
Using other test strips with this meter can produce inaccurate results.

6
En SETTING THE METER

Before using your meter for the first 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.

Setting the Measurement Unit

Start with the meter off (no test strip


inserted). Press SET for 5 seconds to
enter the unit setting mode.

Press and release or to select the


desired measurement unit---mg/dl or
mmol/l.
Press SET.

With the measurement unit flashing,


press or to select „YES“ or „no“.
Press SET to confirm the measurement
unit.

7
SETTING THE METER En

Entering the Setting Mode

Start with the meter off (no test strip


inserted).
Press SET.

1. Setting the date

With the year flashing, press or


until the correct year appears.
Press SET.
With the month flashing, press or
until the correct month appears.
Press SET.

With the day flashing, press or


until the correct day appears.
Press SET.

8
En SETTING THE METER

2. Setting the time format

Press and release or to select the


desired time format --- 12h or 24h.
Press SET.

3. Setting the time

With the hour flashing, press or


until the correct hour appears.
Press SET.
With the minute flashing, press or
until the correct minute appears.
Press SET.

4. Deleting the memory

Deleting the memory „dEL“ and a flash-


ing symbol on the display, select
“No” to keep the results in memory then
press SET to skip.

To delete all the results, press , to


select “Yes” then press to confirm.
“OK” and are displayed on the
meter, which indicates that all data
stored is deleted.

9
SETTING THE METER En

5. Choosing a language

Press the Main button to select L1/ L2.


The default language for the meter is
L1, which is German. To confirm your
selection, press SET.

NOTE:
For this setting of choosing language, it‘s not allowed to have multi-
languages setting under some circumstances, the meter will only be
able to have one language, e.g. Turkish.

6. Setting the speaker volume

There are seven (7) speaking volume


options to choose from. Press Main
button until the desired speaking vo-
lume appears. To confirm your selec-
tion, 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.

10
En SETTING THE MEETER

7. Setting the reminder alarm


You may set up any or all of the remin-
der alarms (1 – 4). The meter displays
“On” or “OFF” and press or
to turn on or turn off to set the first
reminder alarm.

Press or to select “On”, then press


SET to set the hour. When the hour is
flashing, press or button until
the desired hour appears. Press SET to
confirm and go to minutes, press or
until the desired minutes appears.
Press SET to confirm and go to the next
alarm setting.

If you do not want to set an alarm, switch to “OFF” to skip this step.
If you want to turn off an alarm, find the alarm number by pressing
SET in the setting mode, press or 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.

11
THE FOUR MEASURING MODES En

The meter provides you with four modes for measuring, General, AC,
PC and QC.

Modes Use when


General (displays as “Gen”) any time of day without regard
to time since last meal
AC no food intake
for at least 8 hours
PC 2 hours after a meal
QC testing with the control solution

You can switch between each mode by:

1. Start with the meter switched off. In-


sert a test strip to turn on the meter.
The screen will display a flashing
blood drop and “Gen”.

2. Press to switch between General,


AC, PC and QC mode.

12
En CONTROL SOLUTION TESTING

Our 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.

Test strips, control solutions and sterile lancets are included in the
kit (please check the contents on your product box). They can also be
purchased separately. Please make sure you have those items needed for
a blood glucose test beforehand.

Do a control solution test when:


a you first receive the meter,
a you begin using a new vial of test strips,
a you suspect the meter or test strips are not working properly,
a your blood glucose test results are not consistent with how you feel,
or if you think the results are not accurate, or
a you have dropped or think you may have damaged the meter.

13
PERFORMING A CONTROL SOLUTION TEST En

You will need:

1. Meter 2. Test Strip 3. Control Solution

1. Insert the test strip to turn on the meter

Insert the test strip into the meter.


Wait for the meter.
Wait for the meter to display the
and .

2. Press to select this test as a control solution test

With “QC” displayed, the meter will


store your test result in memory under
“QC”. If you press again, the “QC”
will disappear and this test is no longer
a control solution test.

14
En PERFORMING A CONTROL SOLUTION TEST

WARNING:
When doing the control solution test, you have to mark it so that
the test result will be stored in the memory under QC. Failure to do
so will mix up the blood glucose test results with the control
solution test results in memory.

X
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 confirmation window
fills completely, the meter will begin counting down. To avoid contaminating
the control solution, do not directly apply control solution onto a strip.

15
PERFORMING A CONTROL SOLUTION TEST En

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.
(100 mg/dl = 5.6 mmol/l;
109 – 165 mg/dl = 6.1 – 9.2 mmol/l)
109~165
Voice Guide
Your blood glucose is 100
milligrams per deciliter.

5. 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 TESTAmed Customer Service hotline
for help.

NOTE:
§ The control solution range printed on the test strip vial is for con-
trol solution use only. It is not a recommended range for your blood
glucose level.
§ See the Meter Maintenance section for important information about
your control solutions.

16
En TESTING WITH BLOOD SAMPLE

WARNING:
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.

Preparing the Lancing Device for Blood Testing

Please follow the instructions in the lancing device insert for collecting
a blood sample.

Preparing the Puncture Site

Stimulating blood perfusion by rubbing the puncture site before blood


extraction has a significant influence on the glucose value obtained.
Blood from a site that has not been rubbed exhibits a measurably dif-
ferent glucose concentration than blood from the finger. When the
puncture site was rubbed prior to blood extraction, the difference was
significantly reduced.

Please follow the suggestions below before obtaining


a drop of blood:
a Wash and dry your hands before starting.
a Select the puncture site either at fingertips or another body parts
(please see section “Alternative Site Testing (AST)” on how to select the
appropriate sites).
a Rub the puncture site for about 20 seconds before penetration.
a Use a clear cap (included in the kit) while setting up the lancing device.

17
TESTING WITH BLOOD SAMPLE En

Fingertip testing

Press the lancing device’s tip firmly against the lower side of your finger-
tip. Press the release button to prick your finger, 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 or hand,
avoid areas with obvious veins in case of excessive 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 that you discard the first drop of blood as it might
contain tissue fluid, which may affect the test result.

18
En ALTERNATIVE SITE TESTING

You can test on a variety of locations on your body.

Important:
There are limitations with AST (Alternative Site Testing).
Please consult your health care professional before you perform AST.

When to use AST ?


Food, medication, illness, stress and exercise can affect blood glucose
levels. Capillary blood at the fingertip reflects 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 finger only.
We strongly recommend that you perform AST ONLY at the following times:
a In a pre-meal or fasting state (more than 2 hours since the last meal).
a Two hours or more after taking insulin.
a Two hours or more after exercise.
Do NOT use AST if:
a You think your blood glucose is low.
a You are unaware of hypoglycemia.
a You are testing for hyperglycemia.
a Your AST results do not match the way you feel.
a Your routine glucose results often fluctuate.

19
PERFORMING A BLOOD GLUCOSE TEST En

You will need:


1. Meter 2. Test Strip 3. Lancing Device 4. Lancet

1. Insert the test strip to turn on the meter


Wait for the meter to display the
and .

Voice Guide
Thank you for using this product.
Please relax during the measurement.
The ambient temperature is 25.8 degrees
Celsius.
Please apply blood onto the test strip.

2. Select the appropriate measuring mode by pressing .


For selecting the measurement mode,
please refer to the “FOUR MEASURING
MODES”.

3. Obtaining a blood sample


Use the pre-set lancing device to punc-
ture the desired site. Wipe off the first
Correct
appeared drop of blood with a clean
cotton swab. The size of the drop should
be at least as big as (actual size), which
is 0.5 microliter (μL) of volume. Gently
squeeze the punctured area to obtain
Incorrect another drop of blood. Be careful NOT
to smear the blood sample.

20
En PERFORMING A BLOOD GLUCOSE TEST

4. Apply the Sample

Correct Incorrect

Gently apply the drop of blood to the


absorbent hole of the test strip at
a tilted angle. Confirmation window
should be completely filled if enough
blood sample has been applied. Do NOT
remove your finger until you hear a
beep sound.

Voice Guide
Please apply blood onto the test strip.

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 confirmation window should be filled 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 filling the confirmation window, please contact
your health care professional or the TESTAmed customer service for
assistance.

21
PERFORMING A BLOOD GLUCOSE TEST En

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 (100 mg/dl = 5.6 mmol/l).

Voice Guide
Your blood glucose is 100 milligrams per
deciliter.

If your blood glucose is out of the


device´s range, you get "HI" or "LO".

Voice Guide
Your blood glucose is out of range, thus
unable to measure.

6. Eject the used test strip

Eject the test strip by pushing the eject


button on the side. Use a sharp bin to
dispose of used test strips. The meter
will switch itself off automatically.
Always follow the instructions in the
lancing device insert when removing
the lancet.

WARNING:
The used lancet and test strip may be biohazardous. Please discard
them carefully according to your local regulations.

22
En 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


1. Press and release .
will appear on the display. Press again, and the first reading
you see is the last blood glucose result along with date, time and the
measurement mode. (300 mg/dl = 16.7 mmol/l)

2. Press or to recall the test results stored in the meter.


(200 mg/dl = 11.1 mmol/l)

Press the button to recall the test results stored in the meter each
time you press. After the last test result, press again and the meter
will be turned off.

Voice Guide
Your blood glucose is 200 milligrams per deciliter.

23
METER MEMORY En

Reviewing Blood Glucose Day Average Results

1. Press and release .


When appears on the display, keep pressing for 3 seconds
until the flashing “Day Avg” appears. Release and then your 7-day
average result measured in general mode will appear on the display.
(100mg/dl = 5.6 mmol/l)

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.

3. Exit the meter memory.


Keep pressing and the meter will be turned 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.

24
En METER MEMORY

Downloading Results onto a Computer

Data Transmission Via Built-in USB

You can use the meter with the built-in USB and the Health Care Software
System to view test results on your personal computer. To learn more
about the Health Care Software System, please contact TESTAmed
customer services for assistance.

1. Installing the software


To download the Health Care Software System, please visit the TESTAmed
website: www.testamed.de

2. Connecting to a personal computer

Push the USB slider up and insert the


built-in USB of the meter to a USB port
on your computer.
With the meter switched off, „USb“ will
appear on the meter display, indicat-
ing that the meter is in communication
mode.

3. Data transmission
To transmit data, follow the instructions provided with the software.
Results will be transmitted with date and time. Pull out the built-in USB of
the meter from your computer, 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.

25
MAINTENANCE En

Battery

Your meter comes with two 1.5V AAA size alkaline batteries.

Low Battery Signal

The meter will display one of the messages below to alert you when the
meter power is getting low.

1. The symbol appears along


with display messages. The meter is
func-tional and the result remains ac-
curate, but it is time to change the
batteries.

2. The symbol appears with E-b,


warning symbol and low:
The power is not enough to do a
test. Please change the batteries
immediately.

26
En MAINTENANCE

Replacing the Battery

To replace the batteries, make sure that the meter is turned off.

1. Press the edge of the battery cover and lift it up to remove.

2. Remove the old batteries and replace with two 1.5V AAA size alkaline
batteries.

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).
§ Properly dispose of the batteries according to your local environ-
mental regulations

27
MAINTENANCE En

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

1. 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 dry cloth.
Do NOT rinse with water.
2. Do NOT use organic solvents to clean the meter.

Meter Storage

§ Storage conditions: -4 °F – 140 °F (-20 °C – 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.

28
En MAINTENANCE

Caring for Your Test Strips

§ Storage conditions: 35.6 °F – 89.6 °F (2 °C – 32 °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 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 first opened it.
Discard remaining test strips after 6 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.

29
MAINTENANCE En

Important Control Solution Information

§ Use only our control solutions with your meter.


§ Do not use the control solution beyond the expiry date or 3 months after
first 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 tem-
perature 68 °F – 77 °F (20 °C – 25 °C). Make sure your control solution,
meter, and test strips are at this specified temperature range before
testing.
§ Shake the vial before use, discard the first 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
36 °F – 86 °F (2 °C – 30 °C). Do NOT freeze.

30
En SYSTEM TROUBLESHOOTING

If you follow the recommended action but the problem persists, or error
messages other than the ones below appear, please call your TESTAmed
customer service. Do not attempt to repair yourself and never try to
disassemble the meter under any circumstances.

Result Readings

MESSAGE WHAT IT MEANS


Appears when
glucose < 20 mg/dl (1.1 mmol/l)

Voice Guide
Your blood glucose is out of range, thus unable to
measure.
Appears when
glucose ≤ 20 mg/dl (1.1 mmol/l) < 250 mg/dl (13.9
mmol/l)

Voice Guide
Your blood glucose is 100 milligrams per deciliter.
Blinks when
glucose ≥ 250 mg/dl (13.9 mmol/l)

Appears when
glucose > 600 mg/dl (33.3mmol/l)

Voice Guide
Your blood glucose is out of range, thus unable to
measure.

31
SYSTEM TROUBLESHOOTING En

Error Messages

MESSAGE WHAT IT MEANS WHAT TO DO


Appears when the batteries Replace the batteries
cannot provide enough immediately
power for a test

Appears when a used Repeat with a new


test strip is inserted test strip

Appears when ambient System operation range is


temperature is below 50 °F – 104 °F (10 °C – 40 °C)
system operation range

Repeat the test after the


meter and test strip are
in the above temperature
Appears when ambient range
temperature is above
system operation range

Problem with the meter Repeat the test with a new


test strip.
If the meter still does not
work, please contact
the TESTAmed customer
service for assistance.

32
En SYSTEM TROUBLESHOOTING

Troubleshooting

MESSAGE WHAT IT MEANS WHAT TO DO


Appears when test strip is Repeat the test with
removed while counting a new test strip
down, or insufficient blood
volume

Problem with the meter

Review the instructions


Problem with the meter
and repeat the test.

If the meter still does


not work, contact the
TESTAmed customer
service for assistance.
Problem with the meter

33
SYSTEM TROUBLESHOOTING En

Troubleshooting

1. If the meter does not display a message after inserting a test strip:

POSSIBLE CAUSE WHAT TO DO

Batteries exhausted Replace the batteries

Test strip inserted upside Insert the test strip


down or incompletely with contact bars end
first and facing up

Defective meter or test strips Please contact


TESTAmed customer services

2. If the test does not start after applying the sample:

POSSIBLE CAUSE WHAT TO DO

Insufficient blood sample Repeat the test using a new


test strip with larger volume
of blood sample

Defective test strip Repeat the test with a new


test strip

Sample applied after Repeat the test with a new


automatic switch-off test strip.
(3 minutes afterlast user action) Apply sample only when
flashing appears on the display.

Defective meter Please contact


TESTAmed customer services

34
En SYSTEM TROUBLESHOOTING

3. If the control solution testing result is out of range:

POSSIBLE CAUSE WHAT TO DO

Error in performing the test Read instructions thoroughly


and repeat the test again

Control solution vial was poorly Shake the control solution vigorously
shaken and repeat the test again

Expired or contaminated Check the expiry date of the


control solution control solution

Control solution that is Control solution, meter, and test


too warm or too cold strips should be at room tempera-
ture (68 °F – 77 °F / 20 °C – 25 °C)
before testing

Defective test strip Repeat the test with a new


test strip

Meter malfunction Please contact


TESTAmed customer services.

35
DETAILED INFORMATION En

The meter provides you with plasma equivalent results

Time of day Normal plasma glucose


range for people without
diabetes (mg/dl)

Fasting and before meal Less than 100 mg/dl (5.6 mmol/l)

2 hours after meals Less than 140 mg/dl (7.8 mmol/l)

Source: American Diabetes Association (2010). Clinical Practice Recommen-


dations. Diabetes Care, 33 (Supplement 1): S1–S100.

Please consult your doctor to determine a target range that works


best for you.

36
En SYMBOL INFORMATION

SYMBOL REFERENT SYMBOL REFERENT

In vitro diagnostic
Serial number
medical device

Caution, consult
Do not reuse accompanying
documents
Authorised repre-
Consult instructions
sentative in the
for use
European Community

Keep away from Sterilised using


sunlight irradiation

Do not use if package


Keep dry
is damaged

Temperature limita- Disposal of waste


tion equipment

Use by / Expiry date 3V 3 Volt (DC)

Use within 6 months


6M CE Mark (CE 0123)
after first opening

Batch code Humidity limitation

Manufacturer

37
SPECIFICATIONS En

Modell Nr.: REF-Nr. FOS-171V


Dimension & Weight: 95.5(L) x 57(W) x 15(H) mm, 56.6 g
Power Source: two 1.5V AAA alkaline batteries
Display: LCD
Memory: 450 measurement results with respective date and time
External output: USB 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 Condition: 50 °F – 104 °F (10 °C – 40 °C), below 85 % R.H.
(non-condensing)
Storage/Transportation Conditions: -4 °F – 140 °F (-20 °C – 60 °C),
below 95 % R.H.
Measurement Units: mg/dl or mmol/l
Measurement Range: 20 to 600mg/dl (1.1 to 33.3 mmol/l)

This device has been tested to meet the electrical and safety
requirements of:
IEC/EN 61010-1, IEC/EN 61010-2-101, EN 61326-1, IEC/EN 61326-2-6.

38
TESTAmed DIABETES CARE
Customer Support Hotline
0800-TREND 11 (0800-87363-11)*
www.testamed.de
*only available in Germany

Distribution:
Maurer Pharma GmbH
Postfach 12 20
56136 Boppard – Bad Salzig

BioCare Corporation
4F, No. 12, Lane 5, Sec. 2, Nanshan Rd.,
Luzhu Dist., 33852 Taoyuan City, TAIWAN

MedNet GmbH
Borkstraße 10, 48163 Münster – Germany

Version: 2.1
Gültig ab: 2017-03
Client: Sebapharma
Project: TESTAmed Blutzuckergerät
Project No: 22674
Filename: Benutzerhandbuch_EN.ai
Date: 30.05.2017

Client Counselling: Lisa Jacobi-Wichmann


Art Direction: Inga Möller
Production: Guido Stern

Supplier: –
Printing process: Offset
Substrate: Paper

Programm(vers.): InDesign CS5

For further technical questions please contact:


Maria Glade, Tel.: +49(40) 89 96 90-63
[email protected]

PRINTING COLOURS:
Cyan
Magenta
Yellow
Black

TYPEFACE: Antique Olive CE, Wingdings,


Wingdings 3

Information concerning screen definition and overfilling


is not given in this file. Adaptation to the requirements of
lithographic production necessary.

All statutory legal protection will be applied to this artwork. It may


not be duplicated or reproduced without the written consent of
elbedesigncrew GmbH. The application of this artwork for any
purpose other than that stipulated by elbedesigncrew GmbH is
strictly and legally prohibited. Any such use would represent a
breach of copyright.

elbedesigncrew GmbH is not liable for any possible orthographic


text errors or any possible breaches of competition laws, copy-
rights or trademark laws, and for any consequential damages.

Please check this artwork for its legal content and technical requi-
rements. Please proof-read the whole text.

elbedesigncrew GmbH · Bernhard-Nocht-Str. 99 · D-20359 Hamburg


Fon +49(0)40/89 96 90-0 · Fax +49(0)40/89 96 90-44
[email protected] · www.elbedesigncrew.de

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