MTM - Smartwatch MEDISANA - Free user manual and instructions

USER MANUAL MTM MEDISANA

Upper arm blood pressure measuring device MTM

Please fold out this page and leave it folded out for quick reference.

Medical device diagram with labeled parts including a blood pressure monitor, a medical device, and a bag attached to the screen.

1 Upper arm cuff with hose
2 START button
3 Display
4 SET button
5 MODE button
6 USB-Interface
7 Socket for mains adaptor
8 Connector for the hose

Simple line drawing of a human leg in motion, no text or symbols present

Line drawing of a human leg with bandages and a small object on the left (no text or symbols)

Simple line drawing of a person lying on the ground with a heart symbol above their leg (no text or labels)

Simple line drawing of a person sitting on a bench with a hand placed on the leg (no text or symbols)

4.2

Die richtige

Messposition

1.1 Thank you very much

Thank you for your confidence in us and congratulations on your purchase! You have acquired a quality product with your purchase of the Medisana MTM upper arm blood pressure monitor. To ensure the best results and long-term satisfaction with your MEDISANA MTM blood pressure monitor, we recommend that you read the following operating and maintenance instructions carefully.

1.2 Tips for your well being

! WARNING

Do not take any therapeutic measures based on your own measurements! Never change the quantity of medication prescribed by your doctor!

• Irregularity of pulse or arrhythmia can lead to difficulties in recording a correct reading when measurements are taken using oscillometric blood pressure devices.
• If you should suffer from conditions such as arterial occlusive disease, please consult your doctor before using the unit.
• The unit may not be used to check the heart rate of patients with a pacemaker.
• Pregnant patients should take their own personal state of health into consideration and take all necessary precautions before using the unit. If in doubt, consult your doctor.
• Should you experience discomfort or other complaints during measurement, for example pain in the upper arm, please take the following action: Press the START button ② to deflate the cuff immediately. Loosen the cuff and remove it from your arm. Please contact either your dealer or MEDISANA directly.
• Patients with a weak pulse wave should raise their arm and open and close their hand around 10 times before taking a reading. This exercise optimizes the pulse wave and the measuring process.

1.3 Important considerations

• The unit is only to be used for the specific purpose described in these operating instructions.
• Any misuse will void the warranty.
• On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately.
• Do not use the unit near to equipment emitting a strong electric or magnetic field, such as radios. This may impair the correct functioning of the unit.
• Do not let children operate the unit. Medical products are not toys!
• 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.
• Protect the unit from moisture. Should moisture enter the unit, remove the batteries and stop using it immediately. In this case, please contact either your dealer or MEDISANA directly. You can find details of how to contact us on the address page.

1.4 Items supplied and packaging

Please ensure that the package contents are complete.

These are as follows:

• 1 MEDISANA Blood pressure monitor MTM
- 1 Cuff with air hose • 1 USB cable
• 4 Batteries (AA type, LR 6) 1,5V • 1 Software CD
- 1 Storage bag • 1 Operating instructions

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 dealer without delay.

WARNING

To avoid risk of suffocation, keep packaging film away from children!

2.1 What is blood pressure?

Blood pressure is the pressure created in the blood vessels by each heart beat. When the heart contracts (= systole) and pumps blood into the arteries, it brings about a rise in pressure. The highest value is known as the systolic pressure and is the first value to be measured.

When the cardiac muscle relaxes to take in fresh blood, the pressure in the arteries also falls. Once the arteries are relaxed, a second reading is taken – the diastolic pressure.

2.2 How is blood pressure measured?

The MTM is a blood pressure computer which is used to measure blood pressure at the upper arm. The measurement is carried out by a microprocessor, which, via a pressure sensor, measures vibrations resulting from the inflation and deflation of the cuff over the artery.

2.3 Why should you take your blood pressure at home?

MEDISANA has had many years of experience in the field of blood pressure measurement. The high precision of MEDISANA devices has been confirmed by extensive clinical tests, carried out according to strict international standards. One strong argument in favour of taking blood pressure at home is the fact that the readings are taken in familiar surroundings under relaxed conditions. The most important reading is the so-called „baseline value“, the one taken before breakfast, directly after getting up in the morning. As far as it is possible, you should always try to take your blood pressure at the same time and under the same conditions each day.

This ensures comparable results and helps in detecting the first signs of high blood pressure. If high blood pressure remains undetected, it increases the risk of further cardiovascular diseases.

THEREFORE WE RECOMMEND:

Take a blood pressure reading daily and on a regular basis, even if you are experiencing no apparent complaints.

2.4

Blood pressure classification

The following table shows the classification of high and low blood pressure, without taking age into consideration. This blood pressure assessment scale corresponds to the guidelines of the World Health Organisation (WHO).

Low blood pressure Normal blood pressure

systolic below <100 systolic 100 - 139

diastolic below <60 diastolic 60 - 89

Types of high blood pressure

mild hypertension medium hypertension serious hypertension

systolic 140 - 159 systolic 160 - 179 systolic >_180

diastolic 90 - 99 diastolic 100 - 109 diastolic >_110

WARNING

Blood pressure that is too low represents just as great a health risk as blood pressure that is too high! Fits of dizziness may lead to dangerous situations arising (e.g. on stairs or in traffic)!

2.5

Fluctuations in blood pressure

There are many factors that can influence blood pressure. Readings can be affected by stress, fear, heavy physical exertion or the time of day at which they are taken. Your personal blood pressure values are subject to considerable fluctuation during the course of the day and the year. These fluctuations are particularly pronounced in the case of patients suffering from hypertension. Blood pressure is usually at its highest during physical exertion and at its lowest at night when asleep.

2.6

Influencing and evaluating readings

• Measure your blood pressure several times, then record and compare the results. Do not draw any conclusions from a single reading.
• Your blood pressure readings should always be evaluated by a doctor who is also familiar with your personal medical history. When using the unit regularly and recording the values for your doctor, you should visit the doctor from time to time to keep him updated.
• When taking readings, remember that the daily values are influenced by several factors. Smoking, consumption of alcohol, drugs and physical exertion influence the measured values in various ways.
• Measure your blood pressure before meals.
• Before taking readings, allow yourself at least five minutes rest.
• If the systolic and diastolic readings seem unusual (too high or too low) on several occasions, despite correct use of the unit, please inform your doctor. This also applies to the rare occasions when an irregular or very weak pulse prevents you from taking readings.

3.1 Inserting / removing batteries

- + + - + + - ↓ K100

Insertion: Open the battery compartment on the underside of the unit by exerting gentle pressure in the direction indicated by the arrow, and insert the four batteries included with the unit (alkaline batteries, AA type, LR 6). Remember to insert the batteries as indicated in the diagram in the battery compartment. Replace the lid, pressing it until it snaps into place.

Removal: When the battery symbol appears in the display, please replace the batteries with new ones. Should the used batteries be jammed in the compartment, use a pointed instrument, such as a ballpoint pen, to carefully prise them out.

After replacing batteries, remember that the time and date have to be reentered. Previously stored results will be lost. Alternatively, you can use the unit with a mains adaptor (MEDISANA Art.-No. 51036) This connects ⑦ to the socket provided at the back of the unit.

BATTERY SAFETY INFORMATION

• Keep away from children! • Do not recharge!
• Do not short-circuit! • Do not throw into fire!
• Do not dispose of old batteries with your household waste, but dispose of them at a battery collection station at a recycling site or in a shop!

3.2 Setting up the user memory

The MTM gives you the opportunity to assign readings to one of two user memories, each of which provides 99 memory slots.

Press and hold the MODE button ⑤ for several seconds. The symbol for memory 1 in the display ③ starts blinking. You can switch between memory 1 and memory 2 by pressing the SET button ④.

3.3 Setting the measuring mode

With the MTM, you can choose between two measuring modes.

• Single reading
• 3 consecutive readings (Measurement Average Mode = 3/MAM-mode)

In the case of a single reading, just one blood pressure reading is taken and stored.

The 3/MAM-mode is to be recommended if you suffer from severely fluctuating blood pressure. 3 successive readings are taken at 15 second intervals, thus eliminating widely varying readings. In the case of serious deviations, a 4th reading may be taken.

From these three measurements, a weighted average value is calculated, displayed and stored in the selected memory. A reading taken in this way is indicated in the memory by an ▶.

The 3/MAM procedure greatly minimizes the risk of an incorrect reading.

You can activate the 3/MAM-mode by holding down the MODE button 5 for several seconds. The symbol for the selected memory will start to flash. After another short press of the MODE button 5, a flashing A and the flashing text "OFF" will appear in the display 3. By pressing the SET button 4, you can now choose between switching the 3/MAM-mode ON and OFF. When the 3/MAM-mode is activated, an A will appear in the display.

3.4 Setting time and date

You can set the date and time by hol-ding down the MODE button 5 for several seconds. The symbol for the selected memory will start to flash. With two more short presses of the MODE button 5, the number of the year will start to flash in the display. Change the year by pressing the SET button 4. Then use the MODE button 5 to move on to the month, day of the month and time. You can change the values of each using the SET button 4.

4.1 Fitting the cuff

First attach the free end of the cuff's 1 air hose to the designated connector 8 on the unit. Open up the cuff and slip it over the bare left upper arm just above the elbow region. If wearing tight clothing, ensure that the circulation in the arm is not impaired when rolling up the sleeve. Please ensure that the cuff buckle is not positioned directly over the artery, as this can result in an incorrect blood pressure reading.

The hose should run along the centre of the inner arm towards the palm of the hand. Ensure that the cuff itself is not twisted in any way.

Fasten the pressure cuff in such a way that it fits tightly but does not constrict the arm. Do this by passing the end through the buckle, pulling it tight and attaching it to the Velcro fastener.

Simple line drawing of a human arm in motion, no text or symbols present

Simple line drawing of a human leg in motion, no text or symbols present

Simple line drawing of a person lying on the ground with motion lines indicating movement (no text or symbols)

Simple line drawing of a person sitting on a bench with a bag, no text or symbols present

4.2 Correct position for taking readings

• Take readings while in a seated position.
- Relax your arm and rest it lightly on a surface such as a table. Relax during the measuring process: do not move or talk, as this can affect the results.

4.3 Taking blood pressure readings

a. Press the START button 2.

- All the display 3 symbols will appear for approx. two seconds.

- The cuff 1 will then inflate. The increasing pressure is displayed numerically.

- Pressing the START button 2 during inflation will stop the inflation process. The unit switches off and the cuff deflates.

b. The measuring process begins automatically when inflation is complete by releasing the pressure built up in the cuff. The display shows the current pressure in the cuff.

Initially, deflation occurs at a constant speed. As soon as the pulse can be determined, deflation is synchronised with the beating of the heart until the measurement ends. During this time the heart symbol ♥ will flash.

The measurement is complete when the cuff suddenly deflates and readings are displayed next to SYS, DIA and PUL. The MTM's display will be illuminated briefly.

5.1 Recording the results

This unit features 2 separate memories, each with a capacity of 99 memory slots. Results are automatically stored in the memory selected by the user. When the memory is full, the oldest reading is always the first to be deleted.

5.2 Displaying stored results

Press the SET button 4 to display the stored readings. Initially, the average, marked "A", of all readings in the memory selected is displayed.

When the SET button 4 is pressed again, the individual readings (switching between systolic, diastolic, pulse and date/time) of the last measurement stored are displayed. The display 3 will be briefly illuminated while the readings are shown. The symbol A indicates that a reading was taken in 3/MAM-mode.

Press the SET button 4 again to move backwards through the stored readings. At the bottom left of the display, above the symbol MR, the memory number for the reading is displayed. The readings are displayed in reverse order. If, for example, seven readings are stored in total, reading No. 7 (the last, most current measurement) will be displayed first, then reading No. 6 (the second last measurement) etc.

5.3 PC-Link

The unit is supplied with a software CD and a USB cable which you can use to transfer the data from the MEDISANA MTM blood pressure monitor via the USB interface to your computer.

Connect one end of the USB cable to the USB interface ⑥ on the unit and the other end to the USB input socket of your computer. The MTM displays three flashing horizontal lines if connected correctly. Insert the CD into your computer and carry out the installation process. The software guides you through the process. Once you have inserted the CD, the installation routine starts automatically. Simply follow the instructions on your computer monitor. The software has extensive help files in case of problems.

The evaluation software makes it possible to display the measurements graphically or as a table.

5.4

Deleting memory

The data can be deleted from the memory selected by pressing and holding the SET button 4 for about 7 seconds. After 7 seconds, the display 3 shows "CL" which indicates that all data have been deleted.

5.5

Switching off the unit

The unit switches off automatically after about 3 minutes, if no button is pressed during this period. It can also be switched off by pressing the START button ②. The time is on permanent display. A short press of the MODE button ⑤ will bring up the date briefly in the display, then return to the time.

6.1

Guide to

Display Symbols

ERROR Error during measurement

Determining pulse

Batteries low. Please replace batteries.

6.2

Troubleshooting

If the display shows one of the following error messages, this means that the unit was unable to accurately determine blood pressure.

Error messages

Possible causes and solutions

ERR 1

Measurement of the systolic blood pressure was completed.

Either the connection with the hose has been interrupted or no pulse could be determined.

Check the connections between the cuff and the main unit.

ERR 2

Non-physiological pressure has been detected.

Cause: the arm was moved during the measurement.

Repeat the measurement, keeping your arm still.

ERR 3

If the cuff takes too long to inflate, it is possible that the cuff is incorrectly positioned or that the connection with the hose is not airtight.

Check the connections and repeat the measurement.

ERR 4

The difference between systolic and diastolic pressure is abnormally high. Repeat the measurement under relaxed conditions, following the instructions exactly.

If the same error occurs repeatedly with further readings, please contact MEDISANA.

ERR 5

An average value could not be calculated due to unstable conditions while the readings were being taken.

Repeat the measuring process, keeping your arm still and not speaking.

6.3 Care and maintenance

• Remove the batteries before cleaning the unit.
• Never use strong detergents or hard brushes.
• Clean the unit with a soft cloth, moistened with mild soapy water. Do not let water enter the unit. After cleaning, only use the unit when completely dry.
• Remove the batteries from the unit if you do not wish to use it for an extended period of time, otherwise there is a risk of battery leakage.
• Do not expose the unit to direct sunlight, and protect it from dust and moisture.
• Only inflate the cuff when it is in position around the upper arm.
  • Servicing and calibration:

The unit has been calibrated by the manufacturer for a period of two years' use. In the case of commercial use, the unit must be serviced and recalibrated at least once every two years. This calibration will be charged for and can be carried out by an appropriate authority or an authorised service centre - in accordance with the regulations for users of medical equipment.

6.4 Disposal

This product must not be disposed together with the domestic waste.

All users are obliged to hand in all electrical or electronic devices, regardless of whether or not they contain toxic substances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner.

Please remove the battery before disposing of the equipment. Do not dispose of old batteries with your household waste, but dispose of them at a battery collection station at a recycling site or in a shop.

Consult your municipal authority or your dealer for information about disposal.

6.5 Directives / Norms

This blood pressure measuring unit complies with the European regulations EN 1060 Section 1 / 1995 and EN 1060 Section 3 / 1997. DIN 58130, NIBP – Clinical trials EANSI / AAMI SP10, NIPB requirements. The unit conforms to the requirements of the European Norm standard EN 60601-1-2.

Clinical trial results:

Clinical trials for this unit were carried out in the USA and Germany according to the norm DIN 58130 / 1997 procedure N 6 (sequential) and according to the AAMI – Standard (US).

The requirements of the EEC Directives 93 / 42 / EEC for Class II a medical products have been fulfilled.

The CE-mark of this device refers to the EC- Directive 93 / 42 EEC.

Device classification: Class BF

Intended use:

This unit is suitable for non-invasive blood pressure measurement in adults (i.e., suitable for external use).

6.6

Specifications

Name and model : MEDISANA blood pressure monitor MTM

Display system : Digital display

Memory slots : 2 x 99

Measuring technique : Oscillometric

Power supply : 6 V= , 4 x 1,5 V Mignon AA LR 6, Alkaline

Blood pressure

measuring range : 30 - 280 mmHg

Pulse measuring range : 40 - 200 beats / Min.

Maximum error tolerance

for static pressure : ± 3 mmHg

Maximum error tolerance

for pulse rate : ± 5 % of the reading

Pressure generation : Automatic, using micro pump

Deflation : Automatic

Operating conditions : After approx. 3 minutes

Operating conditions: +10 °C to +40 °C,

15 - 85 % humidity

Storage conditions: - 5 °C to + 50 °C

Dimensions : 120 mm x 163 mm x 66 mm

Cuff size : 22 – 32 cm Adult cuff for average

upper arm circumference

Weight : Approx. 483 g incl. batteries

Article number : 51062

EAN number : 4015588510625

Accessories : Mains adapter Art. No. 51036

Cuff, large 32 - 42 cm for

adults with upper arm of large circumference

Art.-No. 51037

0297

In accordance with our policy of continual product improvement, we reserve the right to technical and design changes without notice.

7.1 Warranty and repair terms

Please contact your dealer or the service centre in case of a claim under the warranty. If you have to send in the unit, please enclose a copy of your receipt and state what the defect is.

The following warranty terms apply:

1. The warranty period for MEDISANA products is three years from date of purchase. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.
2. Defects in material or workmanship will be removed free of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period either for the unit or for the replacement parts.
4. The following is excluded under the warranty:

a. All damage which has arisen due to improper treatment, e.g. non-observance of the user instructions.
b. All damage which is due to repairs or tampering by the customer or unauthorised third parties.
c. Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre.
d. Accessories which are subject to normal wear and tear.

1. Liability for direct or indirect consequential losses caused by the unit are excluded even if the damage to the unit is accepted as a warranty claim.

MEDISANA AG

Itterpark 7-9

40724 Hilden

Tel.: [phone] / 2007-60

Fax: [phone]

The service centre address is shown on the last page.

1.1 Merci

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Simple line drawing of a human leg in contact, no text or symbols present

Simple line drawing of a person lying on the ground with a heart symbol above their head (no text or labels)

Simple line drawing of a person sitting on a bench with a foot resting nearby (no text or symbols)

6.5 Directives / Normes

Simple line drawing of a human arm in motion, no text or symbols present

Line drawing of a human leg in a seated posture (no text or symbols)

Simple line drawing of a person lying on the ground with a hand near the head (no text or symbols)

Simple line drawing of a person sitting at a desk with a hand holding an object (no text or symbols)

Simple line drawing of a human leg in motion, no text or symbols present

Simple line drawing of a human leg in motion, no text or symbols present

Simple line drawing of a person lying on the ground with motion lines indicating movement (no text or symbols)

Simple line drawing of a person sitting on a bench with a bag, no text or symbols present

4.2

3.1 Colocar / retirar as pilhas

- + + - + + - ↓ K200

Simple line drawing of a hand holding an object, no text or symbols present

Simple line drawing of a human leg with a bandage and a small object on the left (no text or symbols)

Simple line drawing of a person lying on the ground with a heart symbol above their leg (no text or labels)

Simple line drawing of a person sitting on a bench with a bandage, no text or symbols present

Simple line drawing of a hand holding an object with an arrow indicating motion (no text or symbols)

Simple line drawing of a human leg in motion, no text or symbols present

Simple line drawing of a hand holding an object with a circular symbol above, no text or labels present.

Illustration of a person sitting on a bench with hands placed (no text or symbols)

Simple line drawing of a human leg in motion, no text or symbols present

Simple line drawing of a human leg and wrist (no text or symbols)

Simple line drawing of a person lying on the ground with a heart symbol above their leg (no text or labels)

Simple line drawing of a person sitting on a bench with a bandage, no text or symbols present

Simple line drawing of a human arm and hand (no text or symbols)

Simple line drawing of a human leg in motion, no text or symbols present

Simple line drawing of a person lying on the ground with a heart symbol near the knee (no text or labels)

Simple line drawing of a person sitting on a bench with a hand placed at the desk (no text or symbols)

Simple line drawing of a human leg in motion, no text or symbols present

Simple line drawing of a human leg in motion, no text or symbols present

Simple line drawing of a person lying on the ground with motion lines indicating movement (no text or symbols)

Simple line drawing of a person sitting on a bench with a bag, no text or symbols present

4.2

City Business Centre 41 St.

Olav's Court Surrey Quays

London SE16 2XB

Tel.: [phone]

Fax: [phone]

eMail: [e-mail]

Internet: www.medisana.co.uk

F / NL / B / L

MEDISANA Benelux NV

Euregiopark 18

6467 JE Kerkrade

Tel.: [phone]

MEDISANA HEALTHCARE, S.L.