Microlife BP RM 100: The Risk Manager Instruction Manual

The Risk Manager Instruction Manual: Microlife BP RM 100

The Risk Manager

Instruction Manual

Table of contents

1. Introduction

1.1. Features

1.2. Important information about self-measurement

2. Important information 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. Risk Factor Classification

2.5. MAM technology (Microlife Average Mode)

3. Components of your monitor

4. Using your blood pressure monitor

4.1. Inserting the batteries

4.2. Using an AC adapter (special accessory)

4.3. Cuff connection

4.4. Setting the time and date

4.5. How to input Risk Factors

5. Carrying out a measurement

5.1. Before the measurement

5.2. Common sources of error

5.3. Fitting the cuff

5.4. Measurement mode selection

5.5. Measuring procedure

5.6. Discontinuing a measurement

5.7. Memory recall

6. Error messages/malfunctions

7. Care and maintenance, recalibration

8. Guarantee

9. Technical specifications

10. www.microlife.com

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1. INTRODUCTION

1.1. Features

Your blood pressure monitor is a fully automatic, digital blood pressure measuring device with integrated

MAM technology and automatic risk factor classification 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

the 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 understand what the monitor is doing and the 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

Self-measurement means Control, not diagnosis or treatment. Your values must always be discussed

with your doctor. You should never alter the dosages of any medication without direction from your

doctor.

The pulse reading is not suitable for checking heart pacemakers!

If you have been diagnosed with a severe Arrhythmia or irregular heartbeat, measurements made with

this instrument should only be evaluated after consultation with the doctor.

Electromagnetic interference:

This device contains sensitive electronic components. Avoid strong electrical or electromagnetic fields in

the direct vicinity of the device (e.g. mobile telephones, microwave ovens. Electrical interference can lead

to temporary impairment of the measuring accuracy).

2. IMPORTANT INFORMATION OF BLOOD PRESSURE AND ITS MEASUREMENT

2.1. How does high/low blood pressure arise?

Your blood pressure level is determined in the circulatory center of your brain. Your nervous system allows

your body to adapt or alter blood pressure in response to different situations. Your body alters your pulse

and the width of blood vessels through changes in muscles in the walls of blood vessels.

Your blood pressure reading is highest when your heart pumps or ejects blood. This stage is called your

Systolic Blood Pressure. Your blood pressure is lowest when the heart rests. (in-between beats). This is

called your diastolic blood pressure.

It is critical to maintain blood pressure values within a «normal» range(s) in order to prevent particular

diseases.

2.2. Which values are normal?

Blood pressure is too high if, when taken at rest, your systolic pressure is over 140mmHg and/or your

diastolic pressure is above 90mmHg. If you obtain readings above these levels you should consult your

doctor immediately. High blood pressure values over time damage blood vessels, vital organs such as the

kidney and even your heart.

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Should the systolic blood-pressure values lie between 140mmHg and 160mmHg and/or the diastolic blood-

pressure values lie between 90mmHg and 100mmHg, consult your doctor. Regular self-checks will be

necessary.

When blood-pressure values are too low, i.e. systolic values under 100mmHg and/or diastolic values under

60mmHg, 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 independently alter drug

doses prescribed by your doctor.

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

Range Systolic Diastolic Recommendations

Blood Pressure Blood Pressure

Hypotension lower than 100 lower than 60 Check with 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

Moderate hypertension between 160 and 180 between 100 and 110 Consult your doctor

Serious hypertension higher than 180 higher than 110 Urgent! See your doctor.

Specific systolic higher than 140 lower than 90 Consult your doctor

hypertension

Further information

If your values are mostly «normal» 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».

In any case, please discuss the values with your doctor.

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) over time are associated with conside-

rable risks to health. Blood vessels in your body are endangered due to constriction caused by deposits

in the vessel walls (Arteriosclerosis). This can result in a deficient supply of blood to important organs

(heart, brain, muscles). Additionally, the heart will become structurally damaged.

c) There are many different causes of high blood pressure. We differentiate between the common

primary (essential) hypertension, and secondary hypertension. Secondary hypertension can cause

organ malfunctions. Please consult your doctor for information about the possible origins of your own

increased blood pressure values.

d) There are lifestyle changes you can make to prevent and reduce high blood pressure. These measures

must be part of a healthy lifestyle and include:

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A) Eating habits

Maintain a normal weight as prescribed by your doctor.

Avoid excessive consumption of common salt. Please note many «packaged foods» contain high levels

of salt.

Avoid fatty foods. (Packaged foods are frequently high in fats)

B) Previous illnesses

Consistently follow any medical instructions for treating previous illness such as:

Diabetes (Diabetes mellitus or sugar diabetes)

Fat metabolism disorder

Gout

C) Habits

Eliminate smoking

Drink only moderate amounts of alcohol

Restrict your caffeine consumption (Coffee, tea, chocolate, etc.)

D) Physical conditioning

After a preliminary medical examination, exercise regularly.

Choose sports which require endurance 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

exercise routine. Your physician will help you develop an exercise routine that is appropriate for you.

2.4. Risk Factor Classification

In 1999 the World Health Organization (WHO) issued guidelines for the classification of the risk of a

cardiovascular event (1999 World Health Organization - International Society of Hypertension Guidelines for

the Management of Hypertension; Journal of Hypertension 1999, 17:151-183).

According to these guidelines, patients with high blood pressure are classified into four different risk

classes. Along with the blood pressure, the following risk factors are analyzed: sex, age, smoking,

cholesterol, family history of premature cardiovascular disease, diabetes.

The RM 100 device enables these factors to be entered easily using the «Risk Factor Input» button. In

conjunction with the blood pressure measurement, a risk categorization depending on the number of risk

factors, is then performed automatically by the device and displayed after the measurement.

Blood Pressure in mmHg

Risk Factors Systolic 140 – 159 or Systolic 160 – 179 or Systolic > 179 or

Diastolic 90 - 99 Diastolic 100 - 109 Diastolic > 109

none L (Low Risk) M (Medium Risk) H (High Risk)

1 or 2 M (Medium Risk) M (Medium Risk) VH (Very High Risk)

3 or more OR diabetes H (High Risk) H (High Risk) VH (Very High Risk)

NOR (Normal) is displayed when the systolic measurements are below 140 and diastolic measurements are

below 90 mmHg. Patient should continue self-check.

Patient should consult doctor when risk category is: L, M, H or VH

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WHO guidelines (1999) give the following recommendations:

L Low Risk: Doctor should observe the patient over a significant period of time before deciding weather

to institute drug treatment.

M Medium Risk: Blood pressure and other risk factors should be monitored for several weeks and

obtain further information before doctor decides weather to institute drug treatment.

H High Risk / VH – Very High Risk: Doctor should institute immediate drug treatment for the hyper-

tension and the other risk factors or conditions present.

2.5. MAM technology (Microlife Average Mode)

«MAM technology» is a new type of concept for optimum reliability in self-measurement of blood

pressure.

An advanced measurement accuracy is achieved by the automatic analysis of three successive

measurements.

The new system provides reliable values for the doctor and can be used as the basis for reliable

diagnostics and medication therapy for high blood pressure.

A) Why MAM?

Human blood pressure is not stable and can vary

considerably within a short period of time.

B) Key advantages

Reduction of:

Insufficient rest prior to measurement

Movement artefacts (talking or moving during

measurement)

Cuff positioning influences

C) Medical benefits

Improved accuracy

Reliable patient self-measurement data for the doctor

Safe hypertension diagnosis

Reliable therapy control

D) Measurement sequence

With the full measurement cycles, the total

measurement time remains less than 3 minutes,

compared to a single measurement time of 1.5 minute.

Single results are not displayed.

The display counts down the time remaining until the

next reading.

Due to the «Data Analysis» result, a 4th measurement

may be applied.

Only the final analysed data reading is displayed.

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3. COMPONENTS OF YOUR MONITOR

The illustration shows the device consisting of:

a) Main unit:

AC/DC Power

Socket

Risk Factor Input

Cuff Socket

Confirm Risk

Factor

Time

Start

0/I Button

Single/Average mode switch

b) Upper arm cuff:

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

Large cuff (L) for arm circumference 32-42 cm

(Please note, the large cuff is available as an optional accessory)

4. USING YOUR BLOOD PRESSURE MONITOR

4.1. Inserting the batteries

The 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 1,5V), observing

the indicated polarity.

c) If a battery warning appears in the display, the

batteries are discharged and must be replaced.

Attention!

After the battery warning appears, the device will not work until the

batteries have been replaced.

Please use «AA» Long-Life or Alkaline 1.5V Batteries. The use of

rechargeable batteries (1.2V Accumulators) is not recommended.

If your blood-pressure monitor is left unused for long periods, please

remove the batteries from the device.

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Functional check: Hold on the 0/I button down to test all the display symbols. When functioning correctly

all symbols must appear.

4.2. Using an AC adapter (optional accessory)

It is possible to operate this blood-pressure instrument, with a Microlife AC adapter (output 6 V DC / 600

mA with DIN plug).

a) Plug the AC plug into the socket at the side of

the instrument.

b) Plug the AC adapter into a 230V or 110V power

socket. Test that power is available by pressing

the O/I button.

Note:

No power is taken from the batteries while the AC adapter is connected to the instrument.

If power is interrupted during the measurement (e.g. by accidental removal of the AC adapter from the

socket, the instrument must be reset by removing the plug from its socket and reinserting the connections.

Please consult your dealer if you have questions relating to the AC adapter.

4.3. Cuff connection

Insert the cuff tube into the opening provided on the

left side of the instrument, as shown in the diagram.

4.4. Setting the time and date

This blood-pressure monitor automatically records the time and date of each measurement. This is very

important information as blood pressure normally varies over the course of a day.

1. Press the «Time» button for at least 3 seconds.

The display now indicates the set year, during

which the last two characters flash.

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2. The correct year can be entered by pressing the

« »button.

Tip: Press and hold the button for to advance

quickly.

3. Press the «Time» button again.

The display now switches to the current date,

during which the first character (month) flashes.

4. The corresponding month can now be entered by

pressing the « » button.

5. Repeat the above procedure to adjust date, hour

and minute.

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4.5. How to input Risk Factors

1) Press «Risk Factor Input» button to get into risk

factor input mode. At first, a cursor appears and

points to the first risk factor.

2) Press the « » button to select this risk factor, or

press the «RISK Factor Input» button to ignore

the first risk factor and to shift the cursor to the

next risk factor.

Follow the same procedure to select or ignore

the rest of the risk factors.

Note:

Default setting is None (no risk factor). If no risk factor is selected, the cursor will stay at None too.

All of the selected risk factors will be erased every time when you enter the risk factor inputting mode.

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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 the measurement result. Try to find time to relax by sitting in an armchair in a quiet

atmosphere for about 5 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 their arm can increase blood-pressure. Make sure you are in a

comfortable, relaxed position and do not activate any of the muscles in the measurement arm during

measurement. Use a cushion for support if necessary.

If the arm artery lies considerably lower or higher than the heart, an false reading will be obtained.

Each 15cm difference in height results in a measurement error of 10mmHg!

Cuffs that are too narrow or too short result in false measurement values. Selecting the correct cuff is of

great importance. The correct 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 for the correct size. The permissible range for a Medium cuff is 22-32cm while the permis-

sible range for a Large cuff is 32-42 cm. Note: Only use clinically approved Microlife Cuffs!

A loose cuff causes false measurement values.

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) Place the cuff on the arm as illustrated. Make certain that the lower

edge of the cuff lies approximately 2 to 3 cm above the elbow and

2–3 cm

that the rubber tube leaves the cuff on the inner side of the arm.

c) Tighten the free end of the cuff and close the cuff by affixing the

Velcro.

tube

d) The cuff should be snug on your upper arm so that you can fit 2

fingers between the cuff and your upper arm. Any piece of clothing

which restricts the arm (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 your arm on a table (palm

upwards) so that the cuff is at the same height as the heart. Make

sure that the tube is not kinked.

Comment: 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.

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5.4. Measurement mode selection

Clinical studies demonstrate taking multiple blood pressure readings and calculating an «average» is more

likely to determine your true blood pressure. Your Microlife Average Mode unit allows you to switch the

unit to a special Average Mode setting (MAM) that automatically takes multiple readings!

Average Mode / MAM:

a) If you would like to take an Average Mode measurement,

please slide the switch to position «3».

b) Average Mode takes generally 3 measurements in succession

and calculates the result.

c) An « » symbol in the display indicates that the unit is set

to the Average Mode.

Single mode:

a) If you would like to take single measurement, please slide the

switch to position «1».

b) Single mode only takes 1 measurement.

5.5. Measuring procedure

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

a) Press the START button. The pump begins to inflate

the cuff. The rising pressure in the cuff is shown in the

display.

b) After the suitable inflation pressure has been reached,

the pump stops and the pressure gradually falls. The

cuff pressures are displayed. In case that the 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) Depending on the blood pressure measured and the

risk factors input, together with the result the related

risk class (see 2.4) is indicated in a field with a red

border on the display.

f) The measurement readings remain on the display until

you switch off the instrument. If no button is pressed

for a period of 5 minutes the instrument switches

itself off in order to preserve the batteries.

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g) When the unit is set to Average Mode setting

generally 3 separate measurements will take place in

succession and the monitor will calculate your detected

blood pressure value. There will be 15 seconds resting

time between each measurement. A count down on the

screen indicates the remaining time and a beep will

sound 5 seconds before the 2nd and 3rd readings will

begin. In cases where the data differs significantly

between successive readings, a fourth measurement is

performed before the result will be displayed. In rare

cases the blood pressure is so unstable that even after

four measurements the data varies too much. In this

case «ERR 6» is shown and no result can be given.

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

0n/Off button can be pressed at any time. The device immediately lowers the cuff pressure automatically.

5.7. Memory recall

Pressing the « » button after switch on displays the mean blood pressure for the last 7 days. Every result is

saved and the daily mean determined from all the values measured during a day. The value displayed is the

mean of the last 7 daily means. Only this value can be displayed, no other individual values.

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 The inflation of the cuff takes too long. The cuff is not correctly seated.

ERR 5 The measured results have indicated an unacceptable difference between the systolic and

diastolic pressure. Take another measurement, carefully following the instructions. Contact

your doctor, if you still obtain unusual results.

ERR 6 Single data differ too much during Average Mode even after 4 cycles. No average result can

be displayed.

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

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Other possible malfunctions and possible solutions: 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

1. Check whether the batteries are installed with the correct

instrument is switched on although the

polarity and correct if necessary.

batteries are in place.

2. If the display is unusual, re-insert batteries or exchange them.

The pressure does not rise although the

Check the connection of the cuff tube and connect properly if

pump is running.

necessary.

The device frequently fails to measure

1. Fit the cuff correctly on the arm.

the blood pressure values, or the values

2. Before starting the measurement make sure that the cuff is

measured are too low (too high).

not fitted too tightly and that there is 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.

Every measurement results in different

Please read the following information and the points listed

values although the device functions nor-

under «Common sources of error». Repeat the measurement.

mally and the values displayed are normal.

The blood pressure values measured

Record the daily development of the values and consult your

differ from those measured by the doctor.

doctor about them.

Further information

The level of blood-pressure is subject to fluctuations even in healthy people. It is important to compare

measurements taken under the same conditions and at the same time of day. (Quiet conditions)!

If you have any questions regarding the use of this blood pressure monitor, please ask your dealer or

pharmacist for the Microlife Service representative in your country. The Microlife Service Team will be

happy to help you. Never attempt to repair the instrument yourself!

Any unauthorized opening of the instrument invalidates all guarantee claims!

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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

the cuff carefully and avoid all types of straining

through twisting or buckling.

c) Handle the tube carefully. Avoid stress from pulling,

pinching and sharp edges.

d) Clean the device with a soft, dry cloth. Do not use

gasoline, thinners or similar solvents. Carefully

remove spots on the cuff with a damp cloth and

soapsuds. The cuff should not be washed in a

washing machine or dishwasher!

e) Do not drop the instrument or treat it roughly in any

way. Avoid strong vibrations.

f) Never open the device! This can alter the factory

set calibration and affect the accuracy!

Periodical re-calibration

Sensitive measuring devices must be checked for accuracy from time to time. We recommend a periodical

inspection of your unit by an authorized Microlife dealer every 2 years.

Your authorized Microlife dealer would be pleased to provide more information regarding calibration.

8. GUARANTEE

This blood-pressure monitor is guaranteed for 3 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:

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Gasoline

9. TECHNICAL SPECIFICATIONS

Weight: 600 g (with batteries)

Size: 155 (W) x 127 (L) x 45 (H) mm

Storage temperature: –20 to +50°C

Humidity: 15 to 90% relative humidity maximum

Operation temperature: 10 to 40°C

Display: LCD-Display (Liquid Crystal Display)

Measuring method: Oscillometric

Pressure sensor: Capacitive

Measuring range:

SYS/DIA: 30 to 280 mmHg

Pulse: 40 to 200 beats per minute

Cuff pressure display range: 0–299 mmHg

Measuring resolution: 1 mmHg

Accuracy: Pressure within ± 3 mmHg

Pulse ± 5 % of the reading

Power source: a) 4 x 1.5 V Batteries; size AA

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

Cuffs: M size for arm circumference 22–32 cm or

L size for arm circumference 32–42 cm

Reference to standards: EU directive 93/42/EEC

NIBP - requirements: EN 1060-1 /-3 /-4 & ANSI / AAMI SP10

Technical alterations reserved!

10. www.microlife.com

Detailed user information about our products as well as services can be found at www.microlife.com.

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