Digitensio BP 3BM13P - Blood pressure monitor Marque Verte - Free user manual and instructions

Frequently Asked Questions - Digitensio BP 3BM13P Marque Verte

USER MANUAL Digitensio BP 3BM13P Marque Verte

Batteries and electronic instruments must be disposed of in accordance with the locally applicable regulations, not with domestic waste.

Type BF applied part.

Read the instructions carefully before using this device.

Table of contents

1. Introduction

1.1. Features of BP 3BM1-3P
1.2. Important information about self-measurement

2. Important information on the subject of blood-pressure and its measurement

2.1. How does high/low blood-pressure arise?
2.2. Which values are normal?
2.3. What can be done, if regular high/low values are obtained?
2.4. IHD - Pulse Arrhythmia Detection

3. The various components of the blood-pressure monitor

4. Putting the blood-pressure monitor into operation

4.1. Inserting the batteries
4.2. Using an AC adapter (special accessory
4.3. Cuff connection
4.4. Set time and date
4.5. Select the user

5. Carrying out a measurement

5.1. Before the measurement
5.2. Common sources of error
5.3. Fitting the cuff
5.4. Measuring procedure
5.5. Memory storage and recall of the measurements
5.6. Discontinuing a measurement
5.7. Delete memory

6. Error messages/malfunctions

7. Care and maintenance, recalibration

8. Guarantee

9. Technical specifications and reference to standards

1.1. Features of your BP 3BM1-3P

• Your blood pressure monitor BP 3BM1-3P is a fully automatic, digital blood pressure measuring device for use on the upper arm. This monitor enables very fast and reliable measurement of the systolic and diastolic blood pressure as well your pulse by use of oscillometric method.
  This device is easy to use and is proven in clinical studies to provide excellent accuracy. The large display makes it easy to visualize operational status and cuff pressure during a measurement.
• Please read through this instruction manual carefully before use and then keep it in a safe place. For further questions on the subject of blood pressure and its measurement, please contact your doctor.

Attention!

1.2. Important information about self-measurement

• Do not forget: self-measurement means Control, not diagnosis or treatment. Unusual values must always be discussed with your doctor. Under no circumstances should you alter the dosages of any drugs prescribed by your doctor.
  The pulse display is not suitable for checking the frequency of heart pacemakers!
  In cases of cardiac irregularity (Arrhythmia), measurements made with this instrument should only be evaluated after consultation with the doctor.

Electromagnetic interference:

The device contains sensitive electronic components (Microcomputer). Therefore, avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave cookers). These can lead to temporary impairment of the measuring accuracy.

2. Important information on the subject of blood-pressure and its Measurement

2.1. How does high/low blood-pressure arise?

The level of blood-pressure is determined in a part of the brain, the so-called circulatory centre, and adapted to the respective situation by way of feedback via the nervous system.

To adjust the blood-pressure, the strength and frequency of the heart (Pulse), as well as the width of circulatory blood vessels is altered. The latter is effected by way of fine muscles in the blood-vessel walls. The level of arterial blood-pressure changes periodically during the heart activity: During the «blood ejection» (Systole) the value is maximal (systolic blood-pressure value), at the end of the heart's «rest period» (Diastole) minimal (diastolic blood-pressure value).

The blood-pressure values must lie within certain normal ranges in order to prevent particular diseases.

2.2. Which values are normal?

Blood pressure is too high if at rest, the diastolic pressure is above 90mmHg and/or the systolic blood-pressure is over 140mmHg . In this case, please consult your doctor immediately. Long-term values at this level endanger your health due to the associated advancing damage to the blood vessels in your body.

With blood-pressure values that are too low, i.e. systolic values under 100mmHg and/or diastolic values under 60mmHg , likewise, please consult your doctor.

Even with normal blood-pressure values, a regular self-check with your blood-pressure monitor is recommended. In this way you can detect possible changes in your values early and react appropriately.

If you are undergoing medical treatment to control your blood pressure, please keep a record of the level of your blood pressure by carrying out regular self-measurements at specific times of the day. Show these values to your doctor. Never use the results of your measurements to alter independently the drug doses prescribed by your doctor.

Table for classifying blood-pressure values (units mmHg) according to World Health Organization:

Range Systolic Diastolic Measures Blood-pressure Blood-pressure
Hypotension lower than 100 lower than 60 Consult your doctor
Normal range between 100 and 140 between 60 and 90 Self-check
Mild hypertension between 140 and 160 between 90 and 100 Consult your doctor
Moderately serious between 160 and 180 between 100 and 110 Consult your doctor
Serious hypertension	higher than 180	higher than 110	Consult your doctor i m

Further information

If your values are mostly standard under resting conditions but exceptionally high under conditions of physical or psychological stress, it is possible that you are suffering from so-called «labile hypertension». Please consult your doctor if you suspect that this might be the case.
- Correctly measured diastolic blood-pressure values above 120mmHg require immediate medical treatment.

2.3. What can be done, if regular increased/low values are obtained?

a) Please consult your doctor.
b) Increased blood-pressure values (various forms of hypertension) are associated long- and medium term with considerable risks to health. This concerns the arterial blood vessels of your body, which are endangered due to constriction caused by deposits in the vessel walls (Arteriosclerosis). A deficient supply of blood to important organs (heart, brain, muscles) can be the result. Furthermore, with long-term continuously increased blood-pressure values, the heart will become structurally damaged.
c) There are many different causes of the appearance of high blood pressure. We differentiate between the common primary (essential) hypertension, and secondary hypertension. The latter group can be ascribed to specific organic malfunctions. Please consult your doctor for information about the possible origins of your own increased blood pressure values.
d) There are measures which you can take, not only for reducing a medically established high blood pressure, but also for prevention. These measures are part of your general way of life:

A) Eating habits

• Strive for a normal weight corresponding to your age. Reduce overweight!
• Avoid excessive consumption of common salt.
• Avoid fatty foods.

B) Previous illnesses

Follow consistently any medical instructions for treating previous illness such as:

Diabetes (Diabetes mellitus)
Fat metabolism disorder
Gout

C) Habits

• Give up smoking completely
  Drink only moderate amounts of alcohol
• Restrict your caffeine consumption (Coffee)

D) Physical constitution

After a preliminary medical examination, do regular sport.
- Choose sports which require stamina and avoid those which require strength.
- Avoid reaching the limit of your performance.
- With previous illnesses and/or an age of over 40 years, please consult your doctor before beginning your sporting activities. He will advise you regarding the type and extent of types of sport that are possible for you.

2.4. IHD - Pulse Arrhythmia Detection

Appearance of the Arrhythmia indicator

The appearance of this symbol signifies that a certain pulse irregularity was detected during the measurement. The result can vary from your normal blood pressure. As a rule this is not a cause for concern; however, if the symbol appears more frequently (e.g. several times per week on measurements performed daily) or if it suddenly appears more often than usual, we recommend you inform your doctor. Please show your doctor the following explanation:

Information for the doctor on frequent appearance of the Arrhythmia indicator

This DIGITENSIO POIGNET device is an oscillometric blood pressure measuring device that also analyses the pulse frequency during measurement. The accuracy of this device has been clinically validated.

If pulse irregularities occur during measurement, the arrhythmia symbol is displayed after the measurement. If the symbol appears more frequently (e.g. several times per week on measurements performed daily) or if it suddenly appears more often than usual, we recommend the patient to seek medical advice.

The device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

The illustration shows the blood-pressure monitor, BP 3BM1-3P consisting of:

b) Upper arm cuff:

Medium cuff (AC-1 M) for arm circumference 22-32 cm

4. Using your blood pressure Monitor

4.1. Inserting the batteries

Insert batteries immediately after unpacking the unit. Battery compartment is located on the back of the device (see illustration).

a) Remove cover as illustrated
b) Insert the batteries (4 x size AA 1,5 V), thereby observing the indicated polarity.
c) If the battery warning appears in the display, the batteries are almost flat and must be replaced. After battery warning appears, the device will not work until batteries have been replaced.

Attention!

• Please use «AA» Long-Life or Alkaline 1.5V Batteries. The use of 1.2V Accumulators is not recommended.
• If the blood-pressure monitor is left unused for long periods, please remove the batteries from the device.

Functional check: Press «Memory» button down to test all the display symbols. When functioning correctly all symbols must appear.

4.2. Using an AC adapter (special accessory)

It is possible to operate this blood pressure instrument, with an AC adapter which complies with local regulations (output 6 V DC / 600 mA with DIN plug).

a) Plug the plug into the socket at the left side of the instrument.
b) Plug the mains adapter into a 230/110 V power socket.
c) Test that power is available by pressing the «O/1» button.

Note:

• NNo power is taken from batteries while the AC adapter is connected to the instrument.
• NIf power is interrupted during the measurement (e.g. by accidental removal of AC adapter from the socket), the instrument must be reset by removing the plug from its socket and re-inserting the connections.
• NPlease consult your dealer if you have questions relating to the AC.

4.3. Cuff connection

Insert the cuff tube into the opening provided on the back side of the instrument, as shown in the diagram.

4.4. Setting time and date

This blood-pressure monitor incorporates an integrated clock with date display. This has the advantage, that at each measurement procedure, not only the blood-pressure values are stored, but also the exact moment of the measurement.

After new batteries have been inserted, the device will request a user to set up time/date.

Example: Entering 2008-08-15 Time 09:30)

1. After new batteries have been inserted, the display comes into direct year setting, during which the 4 characters (2005) blink.
2. Enter the correct year by pressing «Memory» button. Each click will change the clock one year. Example: 3 x press.
3. Press «Time» button. The display now switches to the current date, during which the first character (month) blinks.
4. Enter the current month by pressing the «Memory» button.

Example: 7 x presses

1. Please follow the instructions above to set the day, hour and minutes.
2. After all settings have been made, click the «Time» button once.

The date is briefly displayed and then the time. The input is now

confirmed and the clock begins to run.

Note:

• If you want to change date and time, press and hold the time button down for approx. 3 seconds till Year flashes, then you can enter the new values as described above.
• 1 x press on «Memory» button or «Time» button advances one operation.
• Holding the button down speeds up the procedure.

4.5. Select the User

This blood pressure monitor is designed to store 30 measurements for each of two users. Before taking a measurement, be certain that the correct user has been selected.

a) With the unit off, press and hold the «Time» button for 3 seconds until the user icon in the lower left corner of the LCD screen flashes.
b) Press the «Memory» button to toggle between users.
c) Press the «O/I» button to make your selection.

5. Carrying out a measurement

5.1. Before the measurement

• Avoid eating, smoking as well as all forms of exertion directly before measurement. All these factors influence measurement result. Try to find time to relax by sitting in an armchair in a quiet atmosphere for about ten minutes before measurement.
• Remove any garment that fits closely to your upper arm.
  Always measure on the same arm (normally left).
  Take measurements regularly at the same time of day, since blood-pressure changes during the course of the day.

5.2. Common sources of error

Note: Comparable blood-pressure measurements always require the same conditions! These are normally always quiet conditions.

• All efforts by the patient to support the arm can increase the blood-pressure. Make sure you are in a comfortable, relaxed position and do not activate any of the muscles in the measurement arm during the measurement. Use a cushion for support if necessary.
• If the arm artery lies considerably lower (higher) than the heart, an erroneously higher (lower) blood-pressure will be measured! (Each 15cm difference in height results in a measurement error of 10mmHq )
• Cuffs that are too narrow or too short result in false measurement values. Selecting the correct cuff is of extraordinary importance. The cuff size is dependent upon the circumference of the arm (measured in the centre). The permissible range is printed on the cuff. If this is not suitable for your use, please contact your dealer.

Note: Only use clinically approved Cuffs!

• A loose cuff or a sideways protruding air pocket causes false measurement values.
• With repeated measurements, blood accumulates in the arm, which can lead to false results. Consecutive blood pressure measurements should be repeated after a 1 minute pause or after the arm has been held up in order to allow the accumulated blood to flow away

5.3. Fitting the cuff

a) Push the cuff over the left upper arm so that the tube points in the direction of the lower arm.
b) Lay the cuff on the arm as illustrated. Make certain that the lower edge of the cuff lies approximately 2 to 3cm above the elbow and that the rubber tube leaves the cuff on the inner side of the arm.

Important! The mark (ca. 3 cm long bar) must lie exactly over the artery which runs down the inner side of the arm.

c) Tighten the free end of the cuff and close the cuff with the closer.
d) There must be no free space between the arm and the cuff as this would influence the result. Clothing must not restrict the arm. Any piece of clothing which does (e.g. a pullover) must be taken off.
e) Secure the cuff with the Velcro closer in such a way that it lies comfortably and is not too tight. Lay the arm on the table (palm upwards) so that the cuff is at the same height as the heart. Make sure that the tube is not kinked.

Note:

If it is not possible to fit the cuff to your left arm, it can also be placed on the right. However, all measurements should be made using the same arm.

5.4. Measuring procedure

After the cuff has been appropriately positioned the measurement can begin:

a) Press «0/1» button. The pump begins to inflate the cuff.
Rising pressure in the cuff is shown in the display.
b) After suitable inflation pressure has been reached, pump stops and pressure gradually falls, with cuff pressures being displayed.
In case that inflation pressure is not sufficient, the monitor automatically re-inflates to a higher level.
c) When the instrument detects a pulse, the heart symbol in the display starts to flash and a beep is heard for every heartbeat.
d) A longer beep is sounded when the measurement has been completed.

The systolic, and diastolic blood pressures and pulse rate now appear in the display.

e) The appearance of this symbol signifies that an irregular heartbeat was detected. This indicator is only a caution. It is important that you be relaxed, remain still and do not talk during measurements.

NOTE: We recommend contacting your physician if you see this indicator frequently.

f) The measurement readings remain on the display until you switch off the instrument. If no button is pressed for a period of 1 minute the instrument switches itself off in order to preserve the batteries.

5.5. Memory-storage and recall of measurements

The blood-pressure monitor automatically stores the last 30 measurement values for each of 2 users. By pressing «Memory» button, the screen first shows the most recent readings along with date and time. Each time you press the memory button an earlier measurement will be displayed. If an irregular heartbeat interval was detected in any measurements stored in memory, the icon will be displayed.

Further information

Measurements should not occur soon after each other, since otherwise, the results will be falsified. Wait therefore for several minutes in a relaxed position, sitting or lying, before you repeat a measurement.

5.6. Discontinuing a measurement

If it is necessary to interrupt a blood pressure measurement for any reason (e.g the patient feels unwell), the «0/1» button can be pressed at any time. The device then immediately lowers the cuff pressure automatically.

5.7. Delete memory

When the memory has stored 30 results, the display shows «Full M» after a measurement. From this point onwards, a new measured value is stored by overwriting the oldest value.

Clear all values

If you are sure that you want to permanently remove all stored values, hold down the M-button (the instrument must have been switched off beforehand) until «CL» appears and then release the button. To permanently clear the memory, press the M-button while «CL» is flashing. Individual values cannot be cleared.

6. Error messages/malfunctions

If an error occurs during a measurement, the measurement is discontinued and a corresponding error code is displayed. (Example Error no. 1)

Error No. Possible cause(s)

ERR 1	The systolic pressure was determined but afterwards the cuff pressure fell below 20 mmHg. This situation can occur, for example, if the tube becomes unplugged after the systolic blood pressure has been measured. Further possible cause: No pulse has been detected.
ERR 2 Unnatural pressure impulses influence the measurement result. Reason: The arm was moved during the measurement (Artefact).
ERR 3	Inflation of the cuff takes too long. The cuff is not correctly seated or the hose connection is not sealed.
ERR 5	The measured readings indicated an unacceptable difference between systolic and diastolic pressures. Take another reading following directions carefully. Contact you doctor if you continue to get unusual readings.
HI	The pressure in the cuff is too high (over 300 mmHg) OR the pulse is too high (over 200 beats per minute). Relax for 5 minutes and repeat the measurement.*
LO	The pulse is too low (less than 40 beats per minute). Repeat the measurement.*

• Please consult your doctor, if this or any other problem occurs repeatedly.

Other possible malfunctions and their eliminations

If problems occur when using the device, the following points should be checked and if necessary, the corresponding measures are to be taken:

Malfunction Remedy
The display remains empty when the instrument is switched on although the batteries are in place.2. If the display is unusual, remove the batteries and then exchange them for new.	Check whether the batteries are installed with the correct polarity and correct if necessary.
/ iE«AiAIAOAiE iA E IEA AiE> I O} E I iE«O «EE UEE iV E I iEV is running. connect properly if necessary.
The device frequently fails to measure the 1. Fit the blood pressure values, or the values measured 2. Before starting the measurement make sure that are too low (too high). the cuff is not fitted too tightly no rolled-up sleeve exerting pressure on the arm above the measuring position. Take off articles of clothing if necessary.3. Measure the blood pressure again in complete peace and quiet.
UiAPE i>AOAi i IEAiAIO IA E E vviAi IEU> OiAEE UEE* i>AiEAi> EiB although the device functions normally and the values displayed. of error>. Repeat the measurement.
/ iEL E«AiAIAOAiEU> OiA E i>AOAi E vviAEvA EE UEEiV A' E I iE> those measured by the doctor. and consult your doctor about them.

Further information

UEE / iE iUi E vEL	«AiAIOAiE AEAOL iVIEI EviO»I	AeiUi E	f measurements taken under the same conditions and at the same time of day. (Quiet conditions)!
UEE AÉ Vi A}IÉI AÉiU ViE >AELii EAOL iViiE I EAIÀ VIEV	Cardiac Specialists.
UEE / AÉiU ViE AÉ > Ov>VIOAiE I E iiIÉ OÀ «i> EAI» >A'AEO iAÉi iEAC Technical Monitoring Association. (RWTüV-Essen).
UEE vEP OÉ >UiE> PΕμOiAi AEAi} >A'	}Ei iEÖAiE vEi AEL	E«AiAPharmacist

Never attempt to repair the instrument yourself! Any unauthorized opening of the instrument invalidates all guarantee claims!

7. Care and maintenance, recalibration

a) Do not expose the device to either extreme temperatures, humidity, dust or direct sunlight.
b) The cuff contains a sensitive air-tight bubble. Handle this carefully and avoid all types of straining through twisting or buckling.
c) Clean the device with a soft, dry cloth. Do not use petrol, thinners or similar solvent. Spots on the cuff can be removed carefully with a damp cloth and soapsuds. The cuff must not be washed!
d) Handle the tube carefully. Do not pull on it. Likewise, this is not to be buckled or laid over sharp edges.
e) Do not drop the instrument or treat it roughly in any way. Avoid strong vibrations.
f) Never open the device! Otherwise the manufacturer calibration becomes invalid!

Periodical recalibration

Sensitive measuring devices must from time to time be checked for accuracy. We therefore recommend a periodical inspection of the static pressure display every 2 years.

Your specialist dealer would be pleased to provide more extensive information about this.

8. Guarantee

This blood-pressure monitor BP 3BM1-3P is guaranteed for 5 years from date of purchase.

This guarantee includes the instrument and the cuff. The guarantee does not apply to damage caused by improper handling, damage from leaking batteries, accidents, not following the operating instructions or alterations made to the instrument by third parties.

The guarantee is only valid upon presentation of the guarantee card filled out by the dealer.

Name and company address of the responsible dealer:

Weight: 480g (with batteries & cuff)

Size: 148 (L) x 126 (W) x 60 (H) mm

Storage temperature: -20 to +55^ ; 15 to 95% relative humidity maximum

Operation temperature: 10 to 40^; 15 to 95% relative humidity maximum

Display: LCD-Display (Liquid Crystal Display)

Measuring method: oscillometric

Pressure sensor: capacitive

Measuring range:

SYS/DIA: 20 to 280mmHg

Pulse: 40 to 200 per minute

Cuff pressure display range: 0-299 mmHg

Memory: Automatically stores the last 30 measurements for each of 2 users

Measuring resolution: 1mmHg

Accuracy: Pressure within ± 3mmHg

Pulse ± 5% of the reading

Power source: a) 4 dry cells (batteries) UM-3, size AA, 1.5 V

b) AC adapter 6 V DC 600 mA (optional)

Accessoires: type AC-1-M for arm circumference 22-32 cm

Reference to standards: EN 1060-1/-3/-4

IEC 60601-1

IEC 60601-1-2 (EMC)

This device complies with the requirements of the Medical Device Directive 93/42/EEC.

Technical alterations reserved.