Duo Control - Blood pressure monitor Tensoval - Free user manual and instructions

USER MANUAL Duo Control Tensoval

15.3 Service clients 62

MEMO MEMOMEMO MEMO MEMO50

MEMO MEMOMEMO MEMO MEMO78

Italiano120 Preliminary remarks Please read these instructions carefully before first use as correct blood pressure measure- ment depends on the appropriate use of the device. These instructions for use are designed to instruct you, from the very start, in the individual steps of self-measurement of blood pressure using Tensoval duo control. You will thus receive important and helpful hints for producing reliable results for your personal blood pressure profile. Be sure to keep these instructions for use for future refer- ence.121 There are few people whose pulse sounds are so faint that they can- not be picked up by Korotkoff’s method. In these cases, Duo Sensor Technology will automatically kick in to display the oscillometric blood pressure measurements based on arterial pulse waves rather than pulse sounds. Duo Sensor Technology thus pro- duces accurate results and is still easy to use. Comfort Air Technology The Comfort Air Technology enables approxi- mate determina- tion of the systolic blood pressure value during inflation, and on that basis the individually required infla- tion pressure for blood pressure measurement. This allows measure- ments on the upper arm to be taken with less discomfort. Duo Sensor Technology The innovative Duo Sensor Technology combines two professional measuring tech- nologies: the oscillometric technol- ogy and the Korotkoff’s technology. Whilst most automatic blood pres- sure devices only use oscillometric technology, Duo Sensor Technology also utilises Korotkoff’s highly accurate method of blood pressure measurement, which is also used by doctors to measure blood pres- sure. Korotkoff’s principle of blood pres- sure measurement is characterised by its reduced susceptibility to malfunction, producing correct measured values even in patients with a variety of heart rhythm disorders. Doctors use a stethoscope to listen to the so-called Korotkoff sounds and thereby to determine blood pressure; the Tensoval duo control does exactly the same via an integrated microphone.

Duo Sensor Technology122 Table of Contents Page

2.2 Importance of self-measurement of blood pressure 125

2.3 Objectives of self-measurement of blood pressure 126

2.4 Regular blood pressure measurement 126

3. Getting ready for self-measurement 127

3.3 10 golden rules for blood pressure measurement 128

5.3 Deleting the measured values 135

7. Significance of symbols on the device and cuff 140

8.3 Diabetes, history of other medical conditions 141

8.4 Arrhythmias, heart rhythm disorders, cardiac pacemakers 141

9. Maintenance of the device 142

10. Accessories and spare parts 142

11. Warranty conditions 142

12. Technical data 144123

13. Power supply, disposal notes and safety information 145

13.1 Batteries, mains adapters and disposal 145

13.2 Safety information 146

14. Legal requirements and guidelines 146

15. Calibration check and service addresses 146

15.3 Contact information for customer queries 147

English GB2. General information on blood pressure

2.1 Significance of blood pres-

sure values To determine your blood pressure you need to measure two values:

Systolic (upper) blood pressure: is produced when the heart contracts and pumps blood into the blood vessels.

Diastolic (lower) blood pressure: this is the value measured when the heart muscle is dilated and again fills with blood.

Blood pressure readings are expressed in mmHg. The World Health Organisation (WHO) and the International Society of Hypertension (ISH) have developed the following classifica- tion for blood pressure values:

Dear Customer, We are pleased that you have decided to purchase a blood pres- sure device from HARTMANN. Tensoval duo control is a quality product for fully automatic self- measurement of blood pressure on the upper arm. Requiring no pre- liminary settings, this device conveniently inflates automatically for easy, quick and reliable mea- surement of the systolic and diastolic blood pressures as well as the pulse rate. In addition, you are informed if an irregular heartbeat is detected. The used HARTMANN Duo Sensor Technology is based on an innova- tive combination of the proven oscillometric measuring technology used by digital blood pressure devices and Korotkoff’s traditional principle of blood pressure mea- surement applied by the doctor. This device is designed to optimally support you in monitoring your blood pressure. We wish you all the best for your health.2.2 Importance of self-measure- ment of blood pressure Constantly elevated blood pressure multiplies the risk for other health problems. The most common causes of death worldwide are physical consequences such as heart attack, stroke and organic damages. Daily blood pressure monitoring is thus an important measure which will help to protect you from these risks.

Please note that this classification of blood pressure values is inde- pendent of age. Established hypertension (high blood pressure) is defined as mea- surement of a systolic value greater than 140 mmHg and/or a diastolic value greater than 90 mmHg. In general, blood pressure is con- sidered to be too low in women (hypotension) with values of less than 100 mmHg systolic and less than 60 mmHg diastolic, and with values of less than 110 mmHg systolic and less than 70 mmHg diastolic in men. Please note that, unlike too-high blood pressure values, too-low blood pressure values are not usually expected to be associated with health risks. Assessment Systolic pressure Diastolic pressure Optimal up to 120 mmHg up to 80 mmHg Normal up to 130 mmHg up to 85 mmHg Normal limit values 130 – 139 mmHg 85 – 89 mmHg Grade 1 hypertension 140 – 159 mmHg 90 – 99 mmHg Grade 2 hypertension 160 – 179 mmHg 100 – 109 mmHg Grade 3 hypertension over 180 mmHg over 110 mmHg English GB126

2.3 Objectives of self-measure-

ment of blood pressure Your personal blood pressure profile is the regular documentation of the measured values over a certain period of time and therefore impor- tant information. In case of drug treatment in high blood pressure, your doctor can use your blood pressure profile to tailor your treat- ment to your particular needs. The better your drug treatment is tail- ored to your needs, the better you will feel. Regular, accurate blood pressure monitoring with Tensoval duo control will help you achieve this goal. Thickening of the heart muscle, weakness of the heart muscle Heart attack Shrunken kidney, kidney problems, kidney failure Impaired blood flow = higher risk Arteriosclerosis Stroke

High blood pressure Vascular damage Many people manage to lower their blood pressure through life-style changes (such as losing weight, dietary modification and getting more exercise) to levels that do not require drug treatment.

2.4 Regular blood pressure

measurement Numerous factors including phys- ical exertion, taking drugs or the time of day may have an impact on blood pressure. Blood pressure should therefore always be measured at the same time of day under similar conditions.polarities do not match, the device will not work and the batteries may leak! Replace the lid of the battery com- partment, applying gentle pressure until the hook snaps in place. The measured values recorded in the memory will not be lost when changing the batteries. The date settings will also not be lost but the time settings must however be reset.

3. Getting ready for self-

batteries Open the battery cover on the underside of the device by applying gentle pressure on the hook. Insert the four batteries (type AA) so that the positive (+) and nega- tive (–) polarities match the mark- ing of the polarities on the battery compartment as indicated. If the English

3.2 Setting date and time

When you insert batteries for the first time or change the batteries, the device automatically switches to the date / time function. You can also reset the date and time at any point by pressing down the START button for 5 seconds while the device is switched off. When first used, the display shows the number “31” for the day and “12” for the month. The date set is thus the 31st of December. You must correctly set the date / time before using the device for the first time, so that all memory and evaluation functions function correctly. The number on the left (date indication) in the display flashes. Press the (+) or (–) buttons to change the day displayed. For example, press (–) twice to set the date to the 29th of December. Store the current day by pressing the START / STOP button. Now the number on the right flashes, which displays the month. You can set the month also by pressing the (+) or (–) button and store it by press- ing the START / STOP button. Now the year 2011 is dis- played. You can change the year displayed as mentioned above and store it by pressing the START / STOP button. Then you may set the time. The number on the left in the display flashes, indicat- ing 12:00. Once the desired number of hours has been set, store it by pressing the START / STOP button. Now the number on the right flashes. Here you can change the minutes display and store it by pressing the START / STOP button.

3.3 10 golden rules for blood

pressure measurement

5 minutes before measurement. Even deskwork increases blood pressure by an average of approx. 6 mmHg systolic and 5 mmHg diastolic. DATE DATE YEAR TIME TIME 5 min2. Do not consume any coffee or nicotine up to one hour before measurement.3. Do not measure when you have astrong urge to urinate. A full bladder can leadto an increase in blood pressure ofapprox. 10 mmHg.4. Take measure-ments from the naked upper armwhile sitting upright.5. In the case of using a wrist monitor, hold thecuff at heart levelduring the measuring procedure. The cuff ofan upper arm monitor is auto-matically placed at the correct levelof the arm.6. Do not talk or move during the measuring procedure. Talking increasesthe values by approx. 6 – 7 mmHg.7. Wait at least oneminute between two measure-ments, so that the vessels arerelieved from pressure in prepara-tion for a new measurement.8. Enter values in the blood pres-sure diary: note down the meas-ured values,together with any drugs taken, thedate and time in your blood pres-sure diary.9. Take measure-ments regularly. Even if your values have improved, youshould continue to check them formonitoring purposes.10. Always take measurements atthe same time of day. Because a person hasapprox. 100,000 different bloodpressure values every day, individ-ual measurements have no signifi-cance. Only regular measurementsat the same time each day over along period of time allows a mean-ingful evaluation of blood pressurevalues.

9The recess (see illustration in the inside cover of the instructions for use) in the cuff, opposite the grip tab, should lie in the bend of the elbow. The tube should lie in the centre of the bend of the elbow, pointing towards the hand. Now lightly bend your arm, take the free end of the cuff, wrap it firmly round your arm and close the Velcro fastener.

You should take your blood pressure in a quiet place, in a relaxed seated position. Measurement can be taken on the right or left arm. The arm giving higher readings should be used for long-term blood pres- sure monitoring.

Do not take your blood pressure after taking a bath or exercising.

3.4 Applying the cuff

Before you apply the cuff, insert the red cuff connector into the red cuff socket on the left side of the device. Measurement should be taken on the naked upper arm. If your cuff is completely open, thread the end of the cuff through the metal hoop, so as to form a loop. In this instance, the Velcro fastener must be on the outside. Grasp the cuff by the grip tab (see illustration in the inside cover of the instructions for use) and wrap this over the upper arm.The cuff should be firm but not too tight. Important: The correct apply- ing of the cuff is essential for a correct measurement result. The marking on the edge of the cuff helps you to choose the correct cuff size. The white arrow must point to an area within the sizing scale. If the white arrow is outside the scale, you need another cuff size (see Chapter 10 “Accessories and spare parts”).

4. Measuring blood pressure

We recommend carrying out blood pressure measurements whilst seat- ed. Place your arm with the palm relaxed upwards on a support and make sure the cuff is at the level of the heart.

Do not turn the device on until the cuff has been applied, otherwise the cuff can become damaged through the resulting excess pres- sure. Press the START / STOP button. The appearance of all display elem- ents, followed by a flashing part of the progress bar, shows that the device is carrying out a test run for checking and is ready for use. Subsequently, automatic inflation begins. Tensoval duo control is equipped with Comfort Air Technology, whereby the inflation pressure is only as high as neces- sary (30 mmHg over the systolic value), therefore allowing measure- ments to be taken without discom- fort. If this inflation pressure is insufficient, the device continues to pump until a high enough pressure is reached. Three short beeps English GB132 indicate that the necessary inflation pressure has been reached, and that measurement is starting. Then the measuring procedure begins with the release of the air. If you require a higher inflation pressure, you can avoid having to repeat pumping by pressing the blue START / STOP button again after inflation starts and holding down on it until the desired cuff pressure is reached. This should be approx. 30 mmHg over the systolic (upper) value. You can track the measuring progress via the progress bar. This increases during the inflation phase and decreases in the measuring phase. During the measuring phase, you will also see the sym- bols for the two Duo Sensor Technology measuring methods. These indicate that the sensors are functioning correctly. In addition, the heart symbol shows your pulse rate, which is also measured. A long beep indicates the end of measurement. Then the systolic and diastolic blood pressure values appear simultaneously one below the other on the display as well as the pulse rate. Important: You should not move or talk throughout the entire measuring procedure! If you wish to stop the measuring proced- ure for any reason, simply press the START / STOP button. The inflation or measuring procedure is inter- rupted and an automatic fall in pressure occurs. If you see this symbol under the pulse rate, then the device has detected an irregular heartbeat during the measurement. But it is also possible that the measurement was falsified by body movement or talking. The best thing to do is to repeat the measurement. If you regularly see this symbol when measuring blood pressure, we rec- ommend that you have your heart rhythm checked by your doctor. Once the measurement is finished

is displayed on the left. represents the measured values

TIME133 for the first user. Using you can store the measured values for a second user (see 5.1 “Storing mea- sured values”). In order to switch off the device, press the START / STOP button. Otherwise the device will switch itself off automatically after 3 min- utes.

5.1 Storing measured values

The device features two memory buttons and to store measure- ment results for two different users. represents the measured values for a first user, represents the measured values for a second user. When a beep indicates the end of measurement, you may press or to apply the measured value to the respective person. This assign- ment can be made as long as the values are displayed. If you do not assign them, the measured value is automatically stored to the dis- played measurement memory. The time the measurement was taken is always stored with the blood pressure values in order to determine e.g. the morning or evening averages correctly. The time stored in the device must therefore match the actual time of day. (see 3.2 „Setting date and time“).

5.2 Recalling the measured

values Tensoval duo control keeps handy the following measurement mem- ories (corresponding to the ESH (European Society of Hypertension) guidelines)

Individual measurement memory

Average value of all measured blood pressure values per user

Average value of the evening values The device must be switched off to recall data from the measurement memory. Press the memory button for recalling the first user’s stored values and the memory but- ton for the second user’s values. The corresponding symbol and/or will be displayed. Tensoval duo control distinguishes between values measured in the morning and in the evening. Initially, the average of the morning values over the last seven days for the selected person is displayed English

1(A stands for average, 7 stands for seven days). After press- ing again the memory button or , the average of the evening values over the last seven days appears . After pressing the memory button again, the average of all measure- ments appears . The number of the stored measured values is displayed alternately with the sign “A“. Each time the or button is pressed after this, all stored meas- ured values from the last 60 mea- surements appear one after the other, starting with the most recent value, along with the time, date and year, as well as displaying whether it is a morning or evening value (01 is the latest measurement, 02 the next-to-last measurement, ...). The display alter- nates between the time, date and year of the measured value every 2 – 3 seconds. You can switch directly between the two users at any point in the memory display by pressing the respective memory button. Tensoval duo control can store up to 60 measured values for each person ( oder ). The most recent measured value is always in memo- ry position No.1. When all memory positions are occupied, the oldest value will be deleted each time. Important: Tensoval duo control follows the recom- mendations of the European Society of Hypertension and distinguishes between the measured morning values and the measured evening values. This distinction is medically relevant, as blood pressure changes throughout the day. With this infor- mation, your doctor is more likely to find the right treatment option for you in the event of you receiv- ing medical treatment for high blood pressure. A measured value is assigned as a measured morning value if it is taken between 0.00 h and 12.00 h and as a measured evening value if it is taken between 12.01 h and

23.59 h. Please ensure that you

always measure your blood pres- sure at the same time in the morn-

MEMO MEMO MEMO MEMO MEMO

MEMO DATE MEMO MEMO MEMO MEMO MEMOings and evenings. The calculated general mean value is based on all measured values stored for the respective person. If only two measured values are in memory, the mean value will be calculated from these two meas- ured values. If only one measured value is in memory, this measured value corresponds to the mean value. If there is no morning and/or evening value for the last seven days in the memory, then dashes are displayed instead of values in the display for morning and eve- ning averages over the last seven days. If no values are stored at all in the memory, then dashes are also displayed instead of values in the display for the overall average. If an irregular heartbeat was detected during measure- ment, this information is also stored and displayed when recalling the measured values from the device memory, together with the systolic and diastolic blood pressure value, the pulse rate, the time, date and year.

You can cancel the memory’s recall of data at any time by pressing the START / STOP button. Otherwise the device will switch itself off auto- matically after approx. 30 seconds. Even if the power supply fails, e.g. when changing the batteries, the stored values will still be available.

5.3 Deleting the measured

values You can delete the stored values for and separately. In order to delete all values of a user, press the memory button of the correspond- ing measurement memory or . The morning average values over the last seven days will be dis- played. If you press the button again and then hold down the memory button for 4 seconds, the numbers and signs except and/or start to flash in the display. If you hold down the memory button for another 4 seconds, all data for the selected user is deleted. Now the display either shows or . If you would like to delete individ- ual values, please call up the corresponding individual value to be deleted (see 5.2) and press the respective memory button for 4 sec- onds, so that the display flashes. After pressing for another 4 sec- onds, the respective individual value is deleted. Now the display either shows or . English

MEMOImportant: If you release the memory button ahead of time, no data will be deleted. When you delete an individual value, the next oldest measured value shifts to the memory position of the deleted measured value. When a measured value is deleted, the respective average values concerned are also recalculated.

5.4 Using guest mode

When a third person uses Tensoval duo control, it is recommended that they use the guest mode. This one is used to store a measured value neither to the memory positions nor to . This avoids bias to the series of measurements and the average values of the two main users of the device. To take meas- urements in guest mode, start the measuring procedure by simultan- eously pressing the memory buttons and . The START / STOP button need not be pressed. During and at the end of measurement the display simultaneously shows the two symbols and next to the measured values. The measured value can thus not be applied to either person, and the measured values will not be stored. To switch off the device, press the START / STOP button, also in guest mode. Otherwise the device will switch itself off automatically after 3 minutes.

TIME137 Error which has occurred Device will not turn on. Cuff will not inflate. Remedy Check batteries and insert four identical, new batteries, if and when necessary. Ensure the mains adapter is plugged in the connecting socket on the rear side of the device. Check connection between the red cuff connector and the red connecting socket. Check to make sure that only the approved Tensoval duo control cuffs and the corre- sponding connectors were used. Make sure to abide by the 10 rules as well as the instructions in

Chapter 3.3 and take

the measurement again. Apply the cuff so that you are able to push about two fingers between the cuff and the upper arm.

6. Explanation of error displays

Possible causes No batteries, they have been inserted incorrect- ly or are dead. Mains adapter not correctly connected or defective. Cuff connector is incorrectly positioned in the connecting socket of the device. Wrong cuff type connected. Because of external dis- turbances, the meas- ured value could not be accurately determined. Cuff is too loosely applied. English GB138 Error which has occurred Possible causes Cuff does not inflate or does not inflate fast enough. Moving during the measuring procedure. The pressure in cuff exceeds 300 mmHg. Therefore, an automatic fall in pressure occurs. Batteries are almost dead. Only a few more measurements are pos- sible (approx. 30). Batteries are dead and have to be replaced. Remedy Air tube is not correctly inserted into the device. Check the correct posi- tion of the red connector. If this error occurs often, use a new cuff. Do not talk or move during the measuring procedure. Please rest for at least a minute and take the measurement again. Keep new batteries of the same manufacture handy (type AA LR06). Insert new batteries of the same manufacture (type AA LR06). However, please note that the battery sign which appears when the device is turned on together with all display functions, and then goes out again, does not pro- vide an indication of the battery charging level.139 Error which has occurred Implausible measured values. Possible causes Incorrect cuff size. Cuff placed on top of clothing. Rolled-up clothing impedes blood circula- tion. Cuff wrongly applied. Cuff tube folded or squashed. Cuff was not correctly inflated. Moving, talking or excitement during the measuring procedure. Lack of relaxation before taking a meas- urement. Remedy Use the cuff corre- sponding to your upper arm size. Apply cuff on the naked skin. Wear loose clothing. Make sure that rolled-up sleeves do not impair circulation in the upper arm. Take note of the instructions and images showing how to apply the cuff correctly to the upper arm. Ensure that the cuff tube lies straight and loose. Check the correct posi- tion of the upper arm cuff. Please take measure- ments in a relaxed posi- tion whilst seated. Do not talk or move during the measuring proce- dure. Relax for 5 minutes before taking a meas- urement. English GB140

7. Significance of symbols on

the device and cuff Pay attention to the operating instructions Please note Protection from electric shock (type BF)

89522 Heidenheim Germany Electronic device disposal note Disposal note Error which has occurred Implausible meas- ured values. Possible causes Stimulants taken before measurement. Remedy Please avoid alcohol / nicotine and caffeine for one hour before taking a measurement. Please check the possible causes, when an error symbol appears and note the instructions on self-measurement in Chapter 3. Relax for a minute and take the measurement again.

Self-measurement of blood pressure does not replace treatment! So do not interpret your measured values on your own and do not use them for self-prescribed treatment. Take measurements as instructed by your doctor and have confidence in his diagnosis. Take drugs as prescribed by your doctor and never alter the dose on your own. Discuss the appropriate time for self-measure- ment of blood pressure with your doctor.

Blood pressure may change during pregnancy. Regular blood pressure monitoring is particularly important if you have high blood pressure because the elevated blood pres- sure values may affect the develop- ment of the foetus. Check with your doctor whether and, if so, when141 you should carry out self-measure- ment of blood pressure.

8.3 Diabetes, history of other

medical conditions If you have diabetes, hepatic disor- ders or narrowed blood vessels (e.g. arteriosclerosis, peripheral arterial occlusive diseases (PAOD)), you should consult your doctor before carrying out self-measure- ment because altered measured values may occur in such cases. If you suffer from certain blood dis- eases (e.g. haemophilia), severely impaired blood flow or if you take blood-thinning drugs, you should also ask your doctor before carrying out self-measurement.

8.4 Arrhythmias, heart rhythm

disorders, cardiac pacemakers Heart rhythm disorders (arrhyth- mias) are disturbances of the nor- mal rate or rhythm of the heart- beat. A distinction should be made between mild and severe heart rhythm disorders. This can only be determined by a special investiga- tion carried out by a doctor. Using Korotkoff’s technology, Tensoval duo control can measure correctly in the case of various types of heart rhythm disorders and thus produces correct readings. An irregular heartbeat is when the heart rhythm deviates by more than 25 % from the average heart rhythm. If this symbol appears often, it can by a sign of heart rhythm dis- orders. In this case, consult your doctor. Severe heart rhythm disor- ders may produce false measure- ments or impair the measuring accuracy. Please discuss with your doctor whether self-measurement of blood pressure is suitable for you. Altered measured values may occur in the case of self-measure- ment performed by cardiac pace- maker wearers. The blood pressure monitor itself has no impact on the cardiac pacemaker. Please note that the displayed pulse rate is not suitable for checking the rate of cardiac pacemakers. Please check with your doctor whether self- measurement of blood pressure is advisable if you are wearing a car- diac pacemaker. The contraction of the heart muscle is stimulated by electrical signals. A disturbance in these electrical signals is called arrhythmia. This can be caused by genetic disposition, stress, age, lack of sleep, exhaustion, et cetera. A doctor can establish whether an irregular heartbeat is the result of arrhythmia. English GBStandard cuff, small for upper arm circumference of 17 – 22 cm Code no. 900 241 Standard cuff, medium for upper arm circumference of 22 – 32 cm Code no. 900 242 Standard cuff, large for upper arm circumference of 32 – 42 cm Code no. 900 243 Preformed moulded cuff, medium for upper arm circumference of 22 – 32 cm Code no. 900 244 USB kit for connecting the Tensoval duo control to a computer Tensoval mains adapter Code no. 900 152

9. Maintenance of the device

Do not expose the device neither to extreme temperatures nor to humidity, dust or direct sunlight because this may lead to malfunc- tion. This device consists of high-quality electronic precision components. Protect the device from shock and do not immerse in water. Only use a soft, moistened cloth to clean the device. Please use neither a diluter nor alcohol, detergents or solvents. The cuff can be cleaned carefully with a lightly moistened cloth and mild, pH-neu- tral soap. Do not completely immerse the cuff in water. To pro- tect them from external influences keep the device and cuff as well as these instructions in the storage bag.

10. Accessories and spare parts

To ensure measurement accuracy, only use original HARTMANN accessories which may be obtained from your pharmacist or specialist medical supplier. Upper arm Required circumference cuff 17 – 22cm small 22 – 32 cm medium 32 – 42 cm largewarranty certificate direct, or via your dealer to the Customer Services department for your country.

Middle East FZE Dubai AU – PAUL HARTMANN Pty. Ltd. Level 6, 5 Ryder Boulevard Rhodes, NSW 2138 Australia

11. Warranty conditions

We give a 3-year warranty on this high-quality device for measuring blood pressure from the day of purchase and in accordance with the following conditions. Claims must be made during the warranty period. The date of purchase may be documented by the appropriately completed and stamped warranty document or proof of purchase. Within the warranty period, HARTMANN shall replace or repair any faulty device components free of charge which were caused by material or manufacturing errors. This does not extend the warranty period. This warranty is not applicable to damage caused by improper use or unauthorized interference. Parts that are subject to wear and tear, such as batteries, cuffs, mains adapters etc. are excluded from the warranty. Claims for compensation are limited to the value of the goods; compensation for subsequent damages is expressly excluded. In warranty cases please send the device with cuff and, if applicable, the mains adapter together with the fully completed and stamped English GB144

Measuring method: Oscillometric and Korotkoff’s principle of blood pressure measurement Display range: 0 – 300 mmHg Measuring range: Systole (SYS): 50 – 250 mmHg Diastole (DIA): 40 – 160 mmHg Pulse: 40 – 160 beats / minute Technical measuring accuracy: Cuff pressure: +/– 3 mmHg Pulse: +/– 5 % of displayed pulse rate Power supply: 4 x 1.5 V Mignon alkaline-manganese (AA/LR06) batteries or optional HARTMANN Tensoval mains adapter. Battery capacity: Tensoval duo control: > 1,400 measurements Tensoval duo control large: > 1,400 meas- urements Inflation pressure: Min. 140 mmHg Comfort Air Technology: Individually determined inflation pressure dependent on systolic blood pressure +30 mmHg. Automatic switch-off function: 3 minutes after end of measurement Cuff: Standard cuff 22 – 32 cm Large cuff 32 – 42 cm Small cuff 17 – 22 cm (optionally) Preformed moulded cuff 22 – 32 cm (optionally) Pressure release valve: Electronically controlled linear valve Memory capacity: 2 x 60 measurements and mean value over 7 days and overall mean value Operating conditions: Ambient temperature: + 10 °C to + 40 °C (+ 50 °F to + 104 °F)145 Relative humidity: 15 – 90 % Storage / transport conditions: Ambient temperature: – 20 °C to + 50 °C (– 4 °F to + 122 °F) Serial number: In battery compartment Computer connection to PC: With the aid of the USB kit and software the measurement memory and a graphic display of the measured values can be viewed on your computer.

13. Power supply, disposal

notes and safety information

The four high-quality batteries included with the device guaran- tee about 1,400 measurements. Use only high-quality batteries (see specification in Chapter 12 “Technical data”). If you are using less efficient batteries, we can no longer guarantee 1,400 measurements.

Never mix old and new batteries or batteries made by different manufacturers.

Immediately remove exhausted batteries.

If you do not intend to use the device for a longer period of time, you should remove the batteries to prevent possible leakage.

Please help protect the environ- ment: Do not dispose of bat- teries in household waste! Use designated collection points or municipal collection / recycling centres to dispose of hazardous household waste.

Information concerning the disposal of electronic devices (private households): This symbol on products and/or accompanying documents means that spent electronic products must not be mixed with regular household waste. Proper dis- posal is in the interests of environmental protection and prevents possible harmful effects on people and the environment that may result from inappro- priate handling of wastes. English GB1060: Non-invasive blood pressure meas- uring devices, Part 1: General requirements and Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. Clinical testing of measurement accuracy was performed according to the European Standard EN 1060- 4 as well as the ISO Standard 81060-2. Portable and mobile high-frequency and communication devices can impair the functional capability of electronic medical devices. In compliance with European Standard EN 60601-1-2 further information can be supplied by HARTMANN on request.

15. Calibration check and

check Each Tensoval duo control device has been carefully tested by HARTMANN for measuring accur- acy, and been developed for a long useable service life. We recommend a calibration check at intervals of two years in the case of profession- ally used devices, for example in pharmacies, medical practices or hospitals. You should also observe the national regulations determined

Do not leave the device unat- tended near toddlers or persons who cannot operate it them- selves.

Use the device for taking blood pressure measurements on the upper arm only.

Do not expose the device to hard knocks or vibrations.

Do not drop the device to the floor.

Do not excessively bend or fold the arm cuff and the air tube.

The device must not be altered, dismantled or repaired by the user.

Use the device only with the approved upper arm cuff; otherwise the device can be damaged externally or internally.

The cuff tube may only be removed from the device by pulling the red connector. Never pull on the tube itself.

Never inflate the cuff when it is not properly applied to the upper arm

14. Legal requirements and

guidelines Tensoval duo control complies with the requirements of the EC directive 93/42/EEC on medical devices (Medical Device Directive MDD) and bears the CE mark. The device complies, for example, with the European Standard EN15.3 Contact information for customer queries

by the legislator, such as, in Germany, the “Medizinprodukte- Betreiberverordnung” (Medical Device Operating Regulation).

15.2 Instructions for the

calibration check The calibration check can be carried out by the competent authorities or authorised maintenance providers against compensation. A device function check can be carried out on people or using a suitable simu- lator. Calibration check involves testing for leak tightness of the pressure system and possible devia- tions of the pressure reading. Remove at least one battery in order to switch to calibration mode. Hold down on the START / STOP button and then insert the battery. Release the button and, after a few moments, two zeros will appear one above each other on the dis- play. Instructions on the calibration check will be supplied on request to competent authorities or authorised maintenance providers by HARTMANN. English GB6 Polsslag 7 Indicator onregelmatige hartslag 8 Batterijsymbool 9 Oscillometrische meting 10 Korotkoff-meting 11 Geheugen gebruiker 2 12 Geheugen gebruiker 1 13 Voortgangsindicator