Medisana 79030 User manual

Art. 79030 EXACT
MDD 93/42/EWG
GB
0483
Instruction Manual
Please read carefully!
Blood glucose monitor
®
MediTouch 2
for self-testing

Device and controls
1 Explanation of symbols
2 Safety information
2.1 Always observe the following points
2.2 Instructions for your health
2.3 Instructions on how to use the blood
glucose test strips
2.4 Instructions on how to use the control
solution
3 Useful information
3.1 Items supplied and packaging
3.2 Special features of the MEDISANA
blood glucose monitor MediTouch 2
®
4 Getting started
4.1 Inserting the batteries
4.2 Setting the time and date
5 Operating
5.1 Using the control solution
5.2 Preparing the blood glucose test
5.3 Using the AST cap
5.4 Determining the blood glucose level
5.5 Discarding used lancets
5.6 Evaluating a test result
5.7 Typical symptoms of high or low blood
glucose
6 Memory
6.1 Saving the test results
6.2 Accessing and deleting test results
7 Integration in VitaDock online
®
8 Miscellaneous
8.1 Display and troubleshooting
8.2 Cleaning and maintenance
8.3 Reset the meter
8.4 Technical specifications
8.5 MEDISANA MediTouch 2 accessories
®
8.6 Disposal
9 Warranty
9.1 Warranty and repair terms
9.2 Service address
Contents
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1
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6
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4
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Device and controls
Monitor
2
1
3
6
5
4
Display
Battery compartment
(on the back)
- Button
for memory access, to enter
values and to look at test results
- Button
to confirm settings, delete re-
sults or to switch on the device
(press and hold for appr. 3
seconds).
Insertion slot for test strips
Test strip
Connection for USB cable
3
7
>

Device and controls
Test strips, control solution and lancing device
4
A. Blood sample area
(absorbent slot)
B. Reaction cell
C. Grip/holder
D. Insert in the direction
of the arrow
E. Contact electrode
Expiration
date
AST cap
Cap end
(adjus-
table)
Trigger
button
Carrier
Hub
Sleeve
Sample illustration

Display
Date (month:day)
Time
(hours:minutes)
Control solution
measurement mode
Alarm (before
meals with automatic
alarm after 2 hours
to remind you to
perform a test
after meals)
Blood glucose
reading
Insert test
strip
Apply blood or
control solution
Active USB
connection
AM (before noon)
PM (after noon)
Before
Meals (AC)
After
Meals (PC)
System error
Ambient tempe-
ratur error
Unit of measure
Battery symbol
(low battery)
Ketone
Warning regarding
a possible diabe-
tical ketoacidosis.
Consult doctor!
5
Device and controls
>

1 Explanation of symbols
6
This instruction manual belongs to this
device. It contains important information
about starting up and operation. Read
the instruction manual thoroughly.
Non-observance of these instructions
can result in serious injury or damage
to the device.
WARNING
These warning notes must be observed
to prevent any injury to the user.
CAUTION
These notes must be observed to
prevent any damage to the device.
NOTE
These notes give you useful
additional information on the
installation or operation.
LOT number
Manufacturer
Catalogue number
Serial number
The following signs and symbols on items, packaging and in the instruction manual bear important
information:

7
1 Explanation of symbols
<n>
In vitro diagnostic medical device
(for external use only)
This blood glucose monitor corresponds to the requirements of the EU
guideline 98/79 for in vitro diagnostic devices.
Do not re-use
Use by
Storage temperature range
Contains sufficient for <n> tests
Control solution
Discard 6 months after opening

8
2.1 Always observe the following points
This system is intended for taking an adult’s blood glucose test from the finger tip, alternatively
from the ball of the hand or lower arm. Thereby it is a matter of a fast, electro-chemical
determination of the blood glucose level. The FAD-binding glucose-dehydrogenase converts
the glucose in human blood to gluconolactone. The device measures the current, which is
released by this reaction and which is in proportion to the blood glucose volume.
The system is intended for external use (in vitro) and can be used for self-testing by persons
with diabetes or in clinical settings by healthcare professionals as an aid to monitor the
effectiveness of diabetes control.
Intended use
•
•
2 Safety information
IMPORTANT INFORMATION!
RETAIN FOR FUTURE USE!
Read the instruction manual carefully before using this device, especially the
safety instructions, and keep the instruction manual for future use.
Should you give this device to another person, it is vital that you also pass on
these instructions for use.

2 Safety information
9
The system is not suitable for diagnosing diabetes for children younger than 12 years.
For use on older children ask your doctor.
It is not suitable for diagnosing diabetes or for testing the blood glucose levels of newborn
babies.
Contraindications
•
•
• This device measures in mg/dL.
• The unit is only to be used for the specific purpose described in this instruction manual.
• Any misuse will void the warranty.
• Only use the accessories which have been recommended by the manufacturer (test strips,
control solution) with this monitor.
• This device is not designed to be used by persons (including children) with limited physical,
sensory or mental abilities, or by persons with insufficient experience and/or knowledge, unless
under observation by a person responsible for their safety, or unless they have been instructed in
the use of the device.
• Children must be supervised to ensure that they do not play with the device.
• Do not operate the device in the vicinity of highfrequency transmitters, e.g. microwave and short
wave transmitters.
• Do not use the device if it is not working correctly, if it has been dropped or has fallen into water
or has been damaged.
• Protect the unit from moisture. Should moisture enter the unit, remove the batteries and stop
using it immediately. Contact your authorised service centre.

10
• If a fault occurs, do not try to repair the unit yourself. Attempts to do so will void the warranty.
Refer all servicing to authorized service personnel.
• Always keep the monitor clean and store it in a safe place. Protect the monitor from direct
sunlight to prolong its service life.
• Do not store the monitor and the test strips in a vehicle, bathroom or refrigerator.
• Extremely high humidity can affect the test results. A relative humidity of more than 90% can
cause incorrect readings.
• Store the monitor, the test strips and the lancing device out of reach of children and pets.
• Remove the battery if you do not intend to use the monitor for one month or longer.
• Consult your healthcare professional before making a blood glucose test with this device.
2 Safety information

11
2.2 Instructions for your health
• This blood glucose monitor is intended for
actively testing a person’s blood glucose at
home. The reading from a blood glucose
home-test system does not replace a
professional test performed in a laboratory.
• The monitor is intended for external use only
(in vitro).
• Only use fresh, capillary whole blood from the
finger tips for the test.
• You may only adapt the procedure for using
products at home and self-monitoring, if you
have first received the appropriate training to
do so.
• Do not change any treatments as a result of
your blood glucose reading without first
consulting your doctor.
• The system is not suitable for testing critically
ill patients.
• Your monitor only requires one small drop of
blood to perform a test. You can get this from
a fingertip. Use different place for each test.
Repeated lancing in the same place can lead
to infection and numbness.
• Test results below 60 mg/dL (3.3 mmol/L) are
an indication of hypoglycemia, meaning the
blood glucose level is too low. If the reading is
above 240 mg/dL (13.3 mmol/L), symptoms of
a high blood glucose level (hyperglycemia)
can occur. Consult your doctor, if your readings
are regularly above or below these levels.
• If the test results display “HI” or “LO”, perform
the test once again. If you obtain similar rea-
dings again, consult your doctor immediately
and follow his instructions.
• If the proportion of red blood cells (haemotocrit
level) is very high (over 55 %) or very low
(under 30 %), this could distort the test results.
• Dehydration or a lack of water (such as from
sweating) can result in incorrect readings. If
you think you are suffering from dehydration or
a lack of water, consult your doctor immediate-
ly.
• If you have followed the instructions in this
manual and symptoms persist which are not
associated with your blood glucose level or
your blood pressure, consult your doctor.
2 Safety information

• For additional advice on your health, read the
instruction manual for the test strips carefully.
12
WARNING
Risk of infection
Used test strips and lancets are considered to
be hazardous, biological non-biodegradable
waste. Carelessness when disposing of these
items can lead to the spread of infection.
If necessary, consult your local waste disposal
company, your doctor or pharmacist.
Dispose of your used test strips and used
lancets carefully. If you dispose of the used
parts with the household rubbish, make sure
you wrap them first to avoid harming or
infecting other people.
Medical staff or others who use this monitor
on more than one patient must be aware that
all products or objects which come into
contact with human blood must be dealt with
as if they are capable of spreading viral
diseases, even after cleaning.
Never use a lancet or the lancing device on
more than one person.
•
Use a new sterile lancet and a new test strip
for every test.
Lancets, test strips and alcohol pads are
disposable.
Avoid getting hand cream, oil or dirt in or on
the lancet, lancing device and test strip.
•
•
•
•
2 Safety information
•
•

13
2.3 Instructions for using the blood
glucose test strips ®
• Only use these with the MediTouch 2 monitor.
• Store the test strips in their original container.
• To avoid contamination, only touch the test
strips with clean, dry hands. When removing
the strips from the container and inserting them
in the monitor, only touch them using the grip
(holder).
• Close the container again immediately once
you have removed the test strip. This keeps
the test strips dry and free of dust.
• Use the test strip within three minutes of
removing it from the container.
• The test strip is intended to be used only once.
Do not use it again.
• Write the opening date on the label of the
container when you open it for the first time.
Observe the expiry date. The test strips can be
used for approx. six months after opening
the container or until the expiry date, which-
ever comes first.
• Do not use test strips which have already
exceeded the expiry date, as this can distort
the test result. The expiry date is printed on the
container.
• Store the test strips in a cool, dry place but not
in the refrigerator.
• Store the test strips between 2°C and 30°C
(35.6°F - 86°F). Do not freeze the test strips.
• Protect the strips from damp and direct sun-
light.
• Do not apply the blood sample or control
solution to the test strip before you have in-
serted it in the monitor.
• Only apply the blood sample or the control
solution provided on the test strip slot. Applying
any other substance will lead to an imprecise
or incorrect reading.
• The test strips can be used at altitudes of up to
3,048 m without having any impact on test
results.
• Do not bend, cut or adjust the test strips in any
way.
2 Safety information

14
• Keep the container with the test strips away
from children. There is a risk of choking from
the lid. The lid also contains desiccative
substances which could be dangerous if they
are inhaled or swallowed. This could also lead
to skin and eye irritations.
2.4 Instructions on how to use the
control solution
®
• Only use MEDISANA MediTouch 2 control
solution.
®
• Only use with the MediTouch 2 test strips.
• Write the opening date on the label of the
container. The control solution can be used for
approx. three months after opening the con-
tainer or until the expiry date, whichever comes
first.
• Do not use the control solution after the expiry
date.
• The ambient temperature for using the control
solution should lie between 10°C - 40°C
(50°F - 104°F).
• The temperatures for storing and transporting
the control solution should lie between min 2°C
and max 30°C (35.6°F – 86°F). Do not store
the solution in the refrigerator and do not
freeze it.
• Shake the bottle with the control solution well
before you open it. Wipe away the first drop
and use the second one to ensure a good
sample for a precise test result.
• To ensure the control solution does not get
contaminated, wipe away the remaining
solution on the tip of the container with a clean
cloth before closing it again.
• The control solution may stain your clothing.
Rinse the soiled clothing with water and
detergent.
• Do not put any excess control solution back in
the container.
• Close the container carefully after every use.
2 Safety information

3 Useful information
15
Thank you very much G
Thank you for your confidence in us and con-
gratulations! G
®
The blood glucose monitor MediTouch 2 that
you have purchased is a top quality product from
MEDISANA. In order to achieve the desired
®
effect with your MEDISANA MediTouch 2 blood
glucose monitor in the long term, we recommend
that you read the following information on its use
and maintenance carefully.
3.1 Items supplied and packaging
Please check first of all that the device is com-
plete and is not damaged in any way. In case of
doubt, do not use and contact your supplier or
your service centre. G
The following parts are included:
The packaging can be reused or recycled.
Please dispose properly of any packaging ma-
terial no longer required. If you notice any
transport damage during unpacking, please
contact your supplier without delay.
WARNING
Please ensure that the polythene packing is
kept away from the reach of children!
Risk of suffocation!
®
• 1 MediTouch 2 blood glucose monitor,
(Art. 79030)
®
• 1 MediTouch 2 lancing device
®
• 10 MediTouch 2 blood glucose test strips,
(Art. 79038)
®
• 10 MediTouch 2 lancets
®
• 1 MediTouch 2 control solution 4 ml,
(Art. 79039)
• 1 AST cap
• 2 CR2032 lithium batteries
• 1 Storage bag
• 1 Instruction manual
• 1 Quick reference guide
• 1 Teststrips manual
• 1 Control solution manual
• 1 Diary for diabetics

3.2 Special features of the MEDISANA
®
blood glucose monitor MediTouch 2
16
Measuring your blood glucose level regularly can
be a great help when dealing with your diabetes.
This blood glucose monitor is designed so that
you can use it easily, regularly and anywhere you
choose. The lancing device can be set to the
sensitivity of your skin. The diabetic diary
provided helps you to recognise and record the
affect of your eating habits, sport activities or
medication on the test results. Always consult
your doctor about your test results and treatment.
This monitor is intended for actively testing a
person’s blood glucose at home. It is not suitable
for diagnosing diabetes or for testing the blood
glucose of newborn babies.
®
Your MediTouch 2 blood glucose monitor from
MEDISANA consists of five main parts: the blood
glucose monitor, the lancing device, the lancets,
the test strips and the control solution.
These parts are specially designed to be used
together and for their quality to ensure precise
®
test results. Only use MediTouch 2 approved
test strips, lancets and control solution for your
blood glucose monitor. Precise test results can
only be ensured when the monitor is used
properly. Only use fresh, capillary whole blood for
the test, preferably from the finger tips.
The monitor measures the blood glucose level
very precisely. It has an automatic memory for
480 readings with the date and time. It also
calculates the average level using the blood
glucose readings from the previous 7, 14, 30 and
90 days. This allows you to monitor any changes
and discuss them with your doctor.
3 Useful information

4 Getting Started
17
4.1 Inserting the batteries
1. Open the battery com-
partment on the back
side of the device by
sliding the lid in the
direction of the arrow.
2. Insert two batteries as
shown. The device will
emit a short beep after
correct insertion.
3. Close the lid of the
battery compartment.
It will "snap" into its place.
2

18
WARNING
BATTERY SAFETY INFORMATION
• Do not disassemble batteries!
• Remove discharged batteries from the
device immediately!
• Increased risk of leakage, avoid contact
with skin, eyes and mucous membranes!
If battery acid comes in contact with any
of these parts, rinse the affected area with
copious amounts of fresh water and seek
medical attention immediately!
• If a battery has been swallowed seek
medical attention immediately!
• Only replace with batteries of the same
type, never use different types of batteries
together or used batteries with new ones!
• Insert the batteries correctly, observing
the polarity!
• Remove the batteries from the device if it
is not going to be used for an extended
period!
• Keep batteries out of children's reach!
• Do not attempt to recharge these
batteries!
There is a danger of explosion!
• Do not short circuit!
There is a danger of explosion!
• Do not throw into a fire!
There is a danger of explosion!
• Do not throw used batteries into the
household refuse; put them in a
hazardous waste container or take them
to a battery collection point, at the shop
where they were purchased!
4 Getting Started

19
4.2 Setting the time and date
4 Getting Started
1. After insertion of the batteries
the monitor switches on
automatically.
The correct setting of time and date is especially important, if you intend to use the memory
function of the device.
2. The last two digits of the year
flash in the display. Press
to set the correct value and
press to confirm.
3. Repeat step 2, to enter the
date and time. The area
flashes for the setting being
made at the time.
4. The icon appears in
the display.
The device is now ready
for the test with control
solution.
The unit of measure (mg/dL or mmol/L) is installed
in the device. If you want to change the unit of
measure, contact the customer service.
>>
>

20
5 Operating
5.1 Using the control solution
Why do I need to perform a test with control
solution?
When you perform a test with control solution,
you will find out whether your monitor and test
strips work properly and deliver exact readings.
You should perform a test in the following cases:
• You are using the monitor for the first time.
• You have a new container of test strips.
• You suspect the monitor or test strips might not
be working properly.
• The monitor has been dropped.
• You have repeated a test and the results are
still lower or higher than you expected.
• You are practising the test procedure.
Performing a test with control solution
WARNING
Before you perform a test with
control solution, read section 2 on
Safety instructions (p. 8 - 14),
carefully, especially items
2.3 Instructions on using the
blood glucose test strips and
2.4 Instructions on how to use the
control solution.