beurer BM 28 Upper Arm Blood Pressure Monitor Instruction Manual

beurer BM 28 Upper Arm Blood Pressure Monitor

SIGNS AND SYMBOLS

The following symbols are used on the device, in these instructions for use, on the packaging and on the type plate for the device

| Disposal in accordance with the Waste Elec- trical and Electronic Equipment EC Directive WEEE
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| Do not dispose of batteries containing harmful substances with household waste
| Manufacturer
| CE labelling

This product satisfies the requirements of the applicable European and national directives.

| Dispose of packaging in an environmentally friendly manner
| Marking to identify the packaging material. A material abbreviation,

B material number:.1–7 = plastics,

20–22 = paper and cardboard

| Separate the product and packaging elements and dispose of them in accordance with local regulations.
---|---
IP21| Protected against solid foreign objects 12.5 mm in diameter and larger, and against verti- cally falling drops of water
| Direct current

The device is suitable for use with direct current only

UDI| Unique device identifier (UDI)

Identifier for unique product identification

| Batch designation
| Item number
SN| Serial number
| Medical device
| Type BF applied part

Galvanically isolated applied part F stands for floating  meets the requirements for leakage currents for type B

| Temperature range
---|---
| Humidity range
| Atmospheric pressure limitation
| Type
| Date of manufacture

INTENDED USE

Purpose

The blood pressure monitor hereinafter, device is intended for the fully automatic, non-invasive measurement of arterial blood pressure and pulse values on the upper arm.
It is designed for self-measurement by adults in a domestic environment.

Target group

The blood pressure measurement is suitable for adult users whose upper arm circumference is within the range printed on the cuff.

Clinical benefits

The user can record their blood pressure and pulse values quickly and easily using the device. The recorded values are classified according to internationally applicable guidelines and evaluated graphically. Furthermore, the device can de-tect any irregular heart beats that occur during measurement and inform the user via a symbol in the display. The device saves the recorded measurements and can also output av-erage values of previous measurements. The recorded data can provide healthcare service providers with support during the diagnosis and treatment of blood pressure problems, and therefore it plays a part in the long-term monitoring of the user’s health.

Indications

In the event of hypertension or hypotension, the user can in-dependently monitor their blood pressure and pulse values at home. However, the user does not need to be suffering from hypertension or arrhythmia in order to use the device.

Contraindications

Do not use the blood pressure monitor on newborns, children or pets. Persons with reduced physical, sensory or mental capa-bilities should be supervised by a person responsible for their safety and receive instructions from that person on how to use the device. If you have any of the following conditions, it is essential you consult your doctor before using the device: Cardiac arrhythmia, circulatory problems, diabetes, pregnancy, pre-eclampsia, hypotension, chills, shaking. Do not use the device if you are using electrical implants e.g. pacemakers. Do not use the cuff on people who have undergone a mastectomy. Do not place the cuff over wounds as this may cause further injury. Make sure that the cuff is not placed on an arm whose arteries or veins are undergoing medical treatment, e.g. intravascular access or intravascular therapy, or an arte-riovenous (AV) shunt.

WARNINGS AND SAFETY NOTES
General warnings

The measurements you take are for your information only  they are not a substitute for a medical examination.Discuss your measured values with your doctor and never make your own medical decisions based on them e.g. regarding medicine doses.The device is only intended for the purpose described in these instructions for use. The manufacturer is not liable for damage resulting from improper or incorrect use. Using the blood pressure monitor outside your home environment or while on the move e.g. while travelling in a car, ambulance or helicopter, or while undertaking physical activity such as playing sport) can influence the measurement accuracy and cause incorrect measurements. Cardiovascular diseases may lead to incorrect meas-urements or have a detrimental effect on measurement accuracy. Do not use the device at the same time as other medical electrical devices ME equipment. This could cause the measuring device to malfunction and/or an inaccurate measurement. Do not use the device outside of the specified storage and operating conditions. This could lead to incorrect measurements.Only use the cuffs included in delivery or described in these instructions for use with the device. Using a differ-ent cuff may lead to inaccurate measurements. Note that when inflating the cuff, the functions of the limb affected may be impaired.Do not perform measurements more frequently than necessary. Due to the restriction of blood flow, some bruis-ing may occur. Blood circulation must not be stopped for an unneces- sarily long time during the blood pressure measurement. If the device malfunctions, remove the cuff from the arm. Place the cuff on the upper arm only. Do not place the cuff on other parts of the body. The air line poses a risk of strangulation for small chil-dren. Small parts may present a choking hazard for small children if swallowed. They should therefore always be supervised. Do not drop, step on or shake the device. Do not disassemble the device as this may cause damage, faults and malfunctions. Do not use the device if you have metal implants

General precautions
CAUTION
The blood pressure monitor is made from precision and electronic components. The accuracy of the measurements and service life of the device depend on its careful
handling. Protect the device and its mains adapter from impacts, humidity, dirt, marked temperature fluctuations and direct sunlight. Ensure the device is at room temperature before taking  measurement. If the measuring device has been stored close to the maximum or minimum storage and transport temperatures and is placed in an environment with a temperature of 20 °C, it is recommended that you wait approx. 2 hours before using the measuring device. Do not use the device in the vicinity of strong electromagnetic
fields and keep it away from radio systems or mobile telephones. We recommend removing the batteries if the device is not going to be used for a prolonged period of time. Avoid any mechanical restriction, compression or bending of the cuff line. Do not use the device on people with allergies or sensitive skin.

Notes on handling batteries

WARNIN

• If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.
• Choking hazard! Small children may swallow and choke on batteries. Therefore, store batteries out of the reach of small children.
• Seek medical attention immediately if swallowed.
• Risk of explosion! Do not throw batteries into a fire.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
• Do not disassemble, open or crush the batteries.
• Observe the plus + and minus – polarity signs.

CAUTION
 Protect batteries from excessive heat Do not charge or short-circuit the batteries. If the device is not going to be used for a long period of time, remove the batteries from the battery compartment. Use identical or equivalent battery types only. Always replace all batteries at the same time. Do not use rechargeable batteries.

Notes on electromagnetic compatibility

CAUTION

• The device is suitable for use in all environments listed in these instructions for use, including domestic environments.

• The device may not be fully usable in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device.

• Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.

• The use of accessories or replacement parts other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic immunity; this can result in faulty operation.

• Keep portable RF communication devices including peripheral equipment, such as antenna cables or external antennas at least 30 cm away from all device parts, including
  all cables included in delivery.

• Failure to comply with the above can impair the performance of the device.

INCLUDED IN DELIVERY

Check that the exterior of the cardboard delivery packaging is intact and make sure that all contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address.

• 1x blood pressure monitor
• 1x upper arm cuff (22‑42 cm)
• 1x instructions for use
• 4x 1.5V AA LR6 batteries
• 1x storage bag

DEVICE DESCRIPTION

1. Cuff
2. Cuff line
3.  Cuff connector
4. Display
5. Connection for cuff connector
6. Risk indicator
7. Connection for mains part
8. Function buttons -/+
9. START/STOP button
10. M memory button
11. SET button

Information on the display

• Time and date
• Systolic pressure
• Diastolic pressure
• Calculated pulse rate
• Cardiac arrhythmia symbol and Pulse symbol
• Release air
• Memory display:average value morning , evening , memory space number
• Battery replacement symbol
• Alarm function
• Risk indicator
• User memory
• Cuff position control
• Resting indicator

USAGE

Initial use Inserting the batteries

• Remove the battery compartment cover on the back of the device A .
• Insert four 1.5-V AA (alkaline type LR6) batteries. Insert the batteries, making sure the polarity is correct according to the label A .
• Close the battery compartment cover.
• If the symbol is displayed and does not disappear, measurement is no longer possible.
• Replace all the batteries.
• Once the batteries have been removed from the device, the date and time must be set again.
• Any saved measured values are retained.
• Operation with the mains part.
• You can also operate this device with a mains part not included in delivery.
• However, before connecting the device with the mains part, please ensure that you have removed the batteries from the device.
• During mains operation, there must not be any batteries in the battery compartment, as this could damage the device.
• To avoid any potential damage, the device may only be operated with a mains part that meets the specifications.
• Furthermore, the mains part must only be connected to the mains voltage that is specified on the type plate.
• Insert the mains part into the connection provided for this purpose on the right-hand side of the blood pressure monitor.
• Then insert the mains plug of the mains part into the mains socket.
• After using the blood pressure monitor, unplug the mains part from the mains socket first and then disconnect it from the blood pressure monitor. As soon as you unplug
  the mains part, the blood pressure monitor loses the date and time setting but the saved measured values are retained.

Adjusting the settings

Make sure that the device’s settings have been set correctly so you can make full use of all its functions. Otherwise you will not be able to save your measured values with the date and time and access them later. There are two different ways to access the settings menu. Before initial use and after each time you replace the battery. When inserting batteries into the device, you will be taken to the relevant menu automatically. If the batteries have already been inserted. With the device switched off, press and hold the SET
button for approx. 5 seconds. To set the date and time, proceed as follows. Select 12h or 24h mode using the function buttons -/+. Press SET to confirm. The year display will start to flash.Set the year with the function buttons -/+ and confirm with SET. Set the month, day, hour and minute and confirm each with the SET button. The blood pressure monitor switches itself off automatically.

Alarm

Set alarm

You can set 2 different alarm times to remind yourself to take the measurement. To set the alarm, proceed as follows

• Press and hold the function buttons – and + simultaneously for 5 seconds.
• Alarm 1 is shown in the display on or off  flashes at the same time. With the function buttons -/+, choose whether alarm 1 should be activated  on flashes or deactivated off flashes and confirm with the SET button.
• If alarm 1 is deactivated off you automatically switch to setting alarm 2 .
• If alarm 1 is activated, the hours flash on the display. Select the desired hour using the function buttons -/+ and confirm with SET. The minutes flash on the display.
• Select the desired minute using the function buttons -/+ and confirm with SET.
• Alarm 2 is shown in the display, on or off flashes at the same time. To set, proceed as for alarm 1 .
• The blood pressure monitor switches itself off automatically.

Before the blood pressure measurement

General rules when measuring your own blood pressure

In order to generate an informative profile of changes in your blood pressure that can be used for comparisons, you should measure your blood pressure regularly and
always at the same time of day. Measure your blood pressure twice a day: once in the morning after getting up and once in the evening. Always perform the measurement when you are sufficiently physically rested. Avoid taking measurements at stressful times. Do not take a measurement within 30 minutes of eating drinking, smoking or exercising. Before the initial blood pressure measurement, make sure always to rest for about 5 minutes. If you want to take several measurements in succession, always make sure that you leave at least 1 minute between each measurement. Repeat the measurement if you have doubts about the measured value.

Attaching the cuff

You can measure your blood pressure on either arm. Some deviations between the values in the right and left arm are perfectly normal. Always perform the measurement on the arm with the higher blood pressure values. Consult your doctor about this before starting self measurement. Always measure your blood pressure on the same arm. Only use the device with the cuff supplied, based on your upper arm circumference. Before taking the measurement, check the fit using the index mark described below

1. Expose your upper arm. The circulation of the arm must not be hindered by tight clothing or similar.

2. The cuff must be placed on the upper arm so that the bottom edge is positioned 2-3 cm above the elbow and over the artery. The line should point to the centre of the
   palm here. B .The cuff should be fastened so that two fingers fit under the cuff when it is closed C .

3. Now insert the cuff line into the connection for the cuff connector.

4. The cuff is suitable for you if the index mark is within the OK range after fitting the cuff.

Adopting the correct posture

Sit in a comfortable upright position when taking the blood pressure measurement. Lean back so that your back is supported. Place your arm on a surface D.Place your feet flat on the ground next to one another. The cuff must be level with your heart. Stay as still as possible during the measurement and do not talk. Taking a blood pressure measurement

• As described above, attach the cuff and adopt the posture in which you want to perform the measurement.

• Start the blood pressure monitor with the START/STOP button . After the full-screen display, the respective alarm symbols are displayed if alarm 1 / 2 is activated.

• The cuff automatically inflates. The cuff’s air pressure is slowly released. If a tendency for high blood pressure is detected, the cuff re-inflates and the cuff’s pressure is
  increased again. As soon as a pulse is found, the pulse symbol will be displayed.

• The cuff position control symbol is displayed throughout the entire measurement. If the cuff is applied too tightly or too loosely, then displayed.

• In such cases, the measurement is cancelled after approx. 5 seconds and the device switches itself off.

• Apply the cuff correctly and take a new measurement.

• The systolic pressure, diastolic pressure and pulse rate measurements are displayed. A symbol in the display also appears which shows you whether you were sufficiently
  relaxed during the blood pressure measurement or not symbol = sufficiently at rest or  not at rest.

• You can cancel the measurement at any time by pressing the START/STOP button appears if the measurement has not been performed properly. Observe the chapter on error messages troubleshooting in these instructions for use and repeat the measurement.

• Now select the desired user memory by pressing the memory button M. If you do not select a user memory, the measurement is stored in the most recently used
  user memory. The relevant , , or symbol appears on the display.

• To switch off, press the START/STOP button . If you forget to turn off the device, it will switch itself off automatically after approx. 3 minutes. Wait for at least 1 minute before taking another measurement.

Evaluating the results

General information about blood pressure

• Blood pressure is always stated in the form of two values.
• The highest pressure is the systolic blood pressure.
• This occurs when the heart muscle contracts and blood is pumped into the blood vessels.
• The lowest pressure is the diastolic blood pressure.
• This occurs when the heart muscle has completely relaxed again and the heart is filling with blood.
• Fluctuations in blood pressure are normal. Even during repeat measurements, there may be considerable differences between the measured values. One-off or irregular
  measurements therefore do not provide reliable information about the actual blood pressure. Reliable assessment is only possible when you perform the measurement
  regularly under comparable conditions.

Cardiac arrhythmia

The device can identify heart rhythm abnormalities during the blood pressure measurement. If is displayed after the measurement, this indicates that an irregularity has been
detected in your pulse. Repeat the measurement if is displayed. When assessing your blood pressure, only use the results that have been recorded without any irregularities in your pulse. Consult your doctor if is displayed frequently. Only they can determine, through an examination, whether there is an abnormality.

Risk indicator

Measured blood pressure value range| ****

Classification

| Risk indicator colour
---|---|---
Systolic

(in mmHg)

| Diastolic

(in mmHg)

≥ 180| ≥ 110| Stage 3 high blood pressure (severe)| Red
160 – 179| 100 – 109| Stage 2 high blood pressure (moderate)| Orange
140 – 159| 90 – 99| Stage 1 high blood pressure (mild)| Yellow
130 – 139| 85 – 89| High normal| Green
120 – 129| 80 – 84| Normal| Green
< 120| < 80| Optimal| Green

The risk indicator 6 / 21 indicates which category the recorded blood pressure values fall into. If the measured values are in two different categories (e.g. systolic pressure in the
high normal range and diastolic pressure in the normal range  the risk indicator always indicates the higher range high normal in the example described. Note that these default values are for general guidance only, as individual blood pressures may vary. Please note that self-measurement at home usually results in values lower than those recorded at a doctor’s surgery. Consult your doctor at regular intervals. Only they are able to give you personal target values for controlled blood pressure, particularly if you are receiving medical therapy.

Resting indicator (using HSD diagnostics)

One of the most common errors made when taking a blood pressure measurement is not ensuring that the user’s circu- latory system is sufficiently at rest when taking the measure- ment. In this case, the measured systolic and diastolic blood pressure values do not represent the blood pressure at rest. However, it is this blood pressure at rest that should be used to assess the measured values. This blood pressure monitor uses integrated haemodynamic stability diagnostics (HSD) to measure the user’s haemody namic stability when taking the blood pressure measurement. This enables it to indicate whether the blood pressure was taken when the user’s circulatory system was sufficiently at rest.

| The measured blood pressure value was obtained when the user’s circulatory system was sufficiently at rest and reliably represents the blood pressure at rest.
---|---
| Indicates that the value was obtained when the user’s circulatory system was not sufficiently at rest. The blood pressure values measured in this case generally do not represent the blood pressure at rest. The measurement should therefore be repeated after a period of physical and mental rest lasting at least 5 minutes.
No resting indicator symbol is displayed| During the measurement it was not possible to determine whether the user’s circulatory

system was sufficiently at rest. In this case too, the measurement should be repeated after a

period of rest lasting at least 5 minutes.

The user’s circulatory system not being sufficiently at rest can be the result of various factors, such as physical stress, mental strain/distraction, speaking or experiencing cardiac arrhythmia during the measurement. In an overwhelming number of cases, HSD will give a very good guide as to whether the user’s circulatory system is rested when a blood pressure measurement is taken. However, certain patients suffering from cardiac arrhythmia or chronic mental conditions may remain haemodynamically unstable even in the long term, something which persists even after repeated periods of rest. The accuracy of the results for the blood pressure at rest is reduced in these users.Like any medical measurement method, the precision of HS is limited and it can lead to incorrect results in some cases. Nevertheless, the blood pressure measurements taken when
the user’s circulatory syste.

Displaying and deleting measured values

The results of every successful measurement are stored together with the date and time. If there are more than 30 measurements, the oldest measurements are lost.

• Press the memory button M. Select the desired user memory  by pressing the memory button M again.

• If you press the function button +, the average value of all the stored measured values in the user memory will be displayed. If you press the function button + again, the
  average value of the morning measurements for the last 7 days will be displayed (morning: 5 am – 9 am, display

• If you press the function button + again, the average value of the evening measurements for the last 7 days will be displayed evening: 6 pm – 8 pm, display .

• If you continue to press the function button + the most recent individual measured values are displayed in turn with the date and time.

• To switch off, press the START/STOP button.

• If you forget to switch off the device, it will switch itself off automatically after 30 seconds.

• If you want to delete the whole memory for a specific user, press the memory button M. Press and hold the memory button M and the SET button simultaneously
  for 5 seconds.

CLEANING AND MAINTENANCE

Clean the device and cuff carefully using only a slightly damp cloth. Do not use any cleaning solutions or solvents. Under no circumstances hold the device or cuff under
water, as this can cause liquid to enter and damage the device and cuff. If you store the device and cuff, do not place heavy objects on the device and cuff. The cuff line should not be bent sharply. Remove the batteries if the device is not going to be used for a long period of time.

ACCESSORIES AND REPLACEMENT PARTS

Accessories and replacement parts are available on th homepage www.beurer.de, under Service. Please state the corresponding order number.

TROUBLESHOOTING

measurement. Ensure that you do not speak or move during the measurement.
| You moved or spoke during the measure- ment.
| The cuff was not attached correctly.| Please observe the information in chapter Attaching the cuff.
****| An error occurred during the measurement.| Please wait one minute and repeat the measurement. Ensure that you do not speak or move during the measurement.

measu rement to check whether the cuff can be correctly inflated. Make sure that neither your arm nor other heavy objects are pressing on the line and that the line is not bent.
| There is a system error.| If this error message appears please contact Customer Services.
| The batteries are almost empty.| Insert new batteries into the device.

DISPOSAL

Repairing and disposing of the device

• Do not repair or modify the device yourself. Proper operation can no longer be guaranteed in this case.
• Do not open the device except for the battery compartment.
• Failure to comply will invalidate the warranty.
• Repairs must only be carried out by Customer Services or authorised retailers.
• Before making a complaint, first check the batteries and replace them if necessary.
• The device must not be disposed of with household waste.
• Dispose of the device at a suitable local collection or recycling point in your country.
• Dispose of the device in accordance with EC
• Directive WEEE Waste Electrical and Electronic Equipment.
• Please contact the local authorities responsible for waste disposal if you have any questions regarding disposal.
• Disposal of the batteries
• Used, completely discharged batteries must not be disposed of with household waste.
• Dispose of the batteries in specially designated collection boxes, at recycling points or at electronics retailers.
• You are legally required to dispose of the batteries correctly.
• The codes below are printed on batteries containing harmful substances
  • Pb = battery contains lead
  • Cd = battery contains cadmium
  • Hg = battery contains mercury

TECHNICAL SPECIFICATIONS

The batch number is located on the device or in the battery compartment. Technical information is subject to change without notification to allow for updates.

• This device conforms with the European standard
  • EN 60601‑1‑2 (in accordance with CISPR-11
  • IEC 61000‑3‑2, IEC 61000‑3‑3, IEC 61000‑4‑2
  • IEC 61000‑4‑3, IEC 61000‑4‑4, IEC 61000‑4‑5
  • IEC 61000‑4‑6, IEC 61000‑4‑7, IEC 61000‑4‑8
  • IEC 61000‑4‑11 and is subject to particular precautions with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems

may interfere with this device.

• The device complies with Regulation (EU) 2017/745 of the European Parliament and of the Council for medical devices as well as the respective national regulations and the standard IEC 80601-2-30 (Medical electrica equipment Part 2-30.
• Particular requirements for basic safety and essential performance of automated non invasive sphygmomanometers.
• The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long useful life. If the device is used for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address.

Mains part

GUARANTEE/SERVICE
Further information on the guarantee and guarantee conditions can be found in the guarantee leaflet supplied.

References

• Beurer GmbH | Gesundheit und Wohlbefinden
• Beurer Gesundheitsratgeber
• Beurer Health Guide
• Beurer GmbH | Gesundheit und Wohlbefinden

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