Medisana MediTouch 2 User Manual

MEDITOUCH 2 CONNECT

Blood glucose monitor

Memory slots

Test reminder

USB port

Art. 79046

0483

for self-testing

MediTouch 2

connect

Instruction manual

Please read carefully!

IVD

98/79 EG

Certified

medical device

Years warranty

Bluetooth 4.0

Contents

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 connect 4 Getting started

4.1 Inserting the batteries

4.2 Setting the time and date 5 Operating

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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

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6 Memory

6.1 Saving the test results

6.2 Accessing and deleting test results

7 Integration in VitaDock online

8 Data transfer to VitaDock+ app via

Bluetooth

8.1 Manual data transfer of measured results

to VitaDock+ app 9 Miscellaneous

9.1 Display and troubleshooting

9.2 Cleaning and maintenance

9.3 Reset the meter

9.4 Technical specifications

9.5 Accessories

9.6 Disposal

10 Warranty

10.1 Warranty and repair terms

10.2 Service address

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36 36

42 47 48 48 49 50

51 52

Device and controls

Monitor

2 3

4 5

Display

Battery compartment

(on the back)

- Button

for memory access, to enter values and to look at test results

- Button

to confirm settings, delete results or to switch on the device (press and hold for appr. 3 seconds).

Insertion slot for test strips

Test strip

Connection for USB cable

Device and controls

Test strips, control solution and lancing device

Sleeve

Hub

A. Blood sample area

(absorbent slot)

B. Reaction cell C. Grip/holder D. Insert in the direction

of the arrow

E. Contact electrode

YYYY-MM

Sample illustration

Expiration

date

AST cap

Trigger button

Carrier

Cap end (adjustable)

Device and controls

Display

Date (month:day)

Control solution

measurement mode

Alarm (before meals with automatic alarm

after 2 hours to remind

you to perform a test

after meals)

Bluetooth -

Connection

Blood glucose

reading

Insert test

Apply blood or

control solution

Active USB

connection

strip

Ketone

Time

(hours:minutes)

Before

Meals (AC)

After

Meals (PC)

arning regarding a possible diabe-

tical ketoacidosis.

Consult doctor!

System error

Ambient tempe-

ratur error

Unit of measure

Battery symbol

(low battery)

1 Explanation of symbols

The following signs and symbols on items, packaging and in the instruction manual bear important information:

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

Catalogue number

Serial number

Manufacturer

1 Explanation of symbols

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

<n>

Control solution

Discard 6 months after opening

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.

2.1 Always observe the following points

Intended use

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.

2 Safety information

Contraindications

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.

• This device measures in mmol/L.

• 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.

2 Safety information

• 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

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.

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.

2.3 Instructions for using the blood glucose test strips

• Only use these with the MediTouch 2 connect 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.

2 Safety information

• 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

• 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 connect control solution.

• Only use with the MediTouch 2 connect 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.

3 Useful information

Thank you very much! G

Thank you for your confidence in us and congratulations! The blood glucose monitor Medi-

Touch 2 connect that you have purchased is

a top quality product from MEDISANA. i In order to achieve the desired effect with your

MEDISANA MediTouch 2 connect 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 complete 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:

• 1 MediTouch 2 connect blood glucose monitor, (Art. 79046)

• 1 Medisana lancing device

• 10 MediTouch 2 blood glucose test strips,

(Art. 79038)

• 10 MediTouch lancets

• 1 MediTouch 2 connect control solution 4 ml,

(Art. 79039)

• 1 AST cap

• 2 CR2032 lithium batteries

• 1 Storage bag

• 1 Instruction manual & 1 Quick reference guide

• 1 USB-cable

• 1 Teststrips manual

• 1 Control solution manual

• 1 Diary for diabetics

The packaging can be reused or recycled. Please dispose properly of any packaging material 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!

3 Useful information

3.2 Special features of the MEDISANA blood glucose monitor MediTouch 2

connect

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 connect 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 connect

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.

4.1 Inserting the batteries

4 Getting Started

1. Open the battery com-

partment on the back side of the device by sliding the lid in the direction of the arrow.

CR2032

3V x 1

2. Insert two batteries as

shown. The device will emit a short beep after correct insertion.

CR2032

3V x 1

3. Close the lid of the

battery compartment. It will "snap" into its place.

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