Medisana Meditouch User Manual

Blood glucose monitor

MediTouch

Instruction Manual

Please read carefully.

Art. 79026

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Contents

1 Explanation of symbols . . . . . . . . . . . . . . . . 1

2 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.1 Always observe the following

points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.2 Instructions for your health . . . . . . 5

2.3 Instructions on how to use

the blood glucose test strips . . . . 7

2.4 Instructions on how to use

the control solution . . . . . . . . . . . . . . . . . . . . 8

3 Useful information . . . . . . . . . . . . . . . . . . . . . . . . 9

3.1 Items supplied and packaging . . . 9

3.2 Special features of the MEDISANA blood glucose

monitor MediTouch . . . . . . . . . . . . . . . . . . . . 10

4 Getting started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

4.1 Inserting the battery . . . . . . . . . . . . . . . . . . .11

4.2 Setting the time and

date (initial settings) . . . . . . . . . . . . . . . . . . .12

5 Operating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

5.1 Using the control solution . . . . . . . . 14

5.1.1 Why do I need to perform a test with control solution? . . . 14

5.1.2 Performing a test with

control solution . . . . . . . . . . . . . . . . . . . . . . 14

5.1.3 Evaluating the test result . . . . . . 17

5.2 Preparing the blood glucose

t e s t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8

5.2.1 Using the lancing device . . . . . . . 18

5.2.2 Inserting the lancet in the

lancing device . . . . . . . . . . . . . . . . . . . . . . . . . . 18

5.2.3 Using the AST cap . . . . . . . . . . . . . . . . . . 21

5.2.4 Using the alcohol pads . . . . . . . . . . 23

5.3 Determining the blood glucose

l e v e l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4

5.3.1 Performing a blood glucose test with a blood sample

from the finger tip . . . . . . . . . . . . . . . . . . 24

5.3.2 Evaluating a test result . . . . . . . . . . 27

5.3.3 Unusual test results . . . . . . . . . . . . . . . . 27

5.3.4 Comparing your test results

with a laboratory result . . . . . . . . . 28

6 M e m o r y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 9

6.1 Saving the test result . . . . . . . . . . . . . . . . . . 29

6.2 Accessing and deleting

test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

7 Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

7.1 Display and troubleshooting . . . . 32

7.2 Cleaning and maintenance . . . . . .36

7.3 Technical specifications . . . . . . . . . . . . . 37

7.4 MEDISANA MediTouch

accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

7.5 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

8 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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Device and controls

Monitor and lancing device



Battery compartment (on the back)



Monitor



Display



Test strip



-Button for switching on and

entering/selecting



Insertion slot for test strips



-Button for confirming/selecting



Lancing device clamp



Lancing device



Slider switch for ejecting lancet (on the back)



Trigger button



Protective cap (can be removed with ) can be replaced by the AST cap.



Cap end (adjustable)























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Device and controls



 







Display



Time (hours:minutes)



Number of test result



Blood glucose reading



Battery symbol (low battery)



Insert test strip



Apply the blood sample or control solution



System error



Date (month:day)

Test strip



Blood sample area (absorbent slot)



Reaction cell



Grip/holder



Insert in the direction of the arrow



Contact electrode



Explanation of symbols on page 3







 



 

Front Back

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1 Explanation of symbols

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

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

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1 Explanation of symbols

In vitro diagnostic medical device (for external use only)

This blood glucose monitor corresponds to the requirements of the EU guidelines 98/79 for in vitro diagnostic devices and bears the CE marking (conformance label) CE 0483.

Biohazard

Do not re-use

CR2032 lithium battery ( 3 V )

Use by

Storage temperature limitation

Contains sufficient for <n> tests

Control solution

Protect from sunlight

Protect from moisture

System error

Button for confirming/selecting

Button for entering/selecting

<n>

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1 Explanation of symbols

before meals (AC)

after meals (PC)

Morning, from 4:00 am to 10:00 am

Midday, from 10:00 am to 04:00 pm

Evening, from 04:00 pm to 10:00 pm

Night: from 10:00 pm to 04:00 am

Hypoglycemia (low glucose)

1.1 - 3.3 mmol/L (20 - 60 mg/dL)

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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.

Proper 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.

Contraindication

•

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.

2.1 Always observe the following points

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2 Safety Information

• 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 battery and stop using it immediately. Contact your authorised service centre.

• 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.

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).

• It is not suitable for diagnosing diabetes or for

testing the blood glucose of newborn babies.

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2 Safety Information

• from dehydration or a lack of water, consult your doctor

immediately.

• 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.

• 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.

• 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.

• 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.

• 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 3.3 mmol/L (60 mg/dL) are an indication of hypoglycemia, meaning the blood glucose level is too low. If the reading is above 13.3 mmol/L (240 mg/dL), 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 a “HI” = above 33.3 mmol/L (600 mg/dL) or “LO” = below 1.1 mmol/L (20 mg/dL) reading again, consult your doctor immediately and follow his instructions.

• Dehydration or a lack of water (such as from sweating) can result in incorrect readings. If you think you are suffering

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2 Safety Information

2.3 Instructions for using the blood glucose test strips

• Only use these with the MediTouch 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. three months after opening the container or until the expiry date, whichever 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.

WARNING Risk of infection (continued from page 6)

• 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.

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2 Safety Information

• 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 sunlight.

• Do not apply the blood sample or control solution to the test strip before you have inserted 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.

• Do not bend, cut or adjust the test strips in any way.

• 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 MediTouch control solution.

• Only use with the MediTouch 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 container 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.

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3 Useful Information

Thank you very much

Thank you for your confidence in us and congratulations! The blood glucose monitor MediTouch that you have purchased is a top quality product from MEDISANA. In order to achieve the desired effect with your MEDISANA MediTouch 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.

The following parts are included:

• 1 MediTouch blood glucose monitor from MEDISANA

• 1 MEDISANA lancing device

• 10 MediTouch blood glucose test strips

• 10 MediTouch lancets

• 1 MEDISANA control solution

• 5 Alcohol pads

• 1 AST cap

• 1 CR2032 lithium battery

• 1 Storage bag

• 1 Instruction manual

• 1 Quick reference guide

• 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.

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3 Useful Information

WARNING

Please ensure that the polythene packing is kept away from the reach of children! Risk of suffocation!

3.2 Special features of the MEDISANA MediTouch blood glucose monitor

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 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 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 360 readings with the date and time. It also calculates the average level using the blood glucose readings from the previous 7, 14, 30, 60 and 90 days. This allows you to monitor any changes and discuss them with your doctor.

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