BM 53 - Blood pressure monitor BEURER - Free user manual and instructions

USER MANUAL BM 53 BEURER

Unfold page 3 before reading the instructions for use.

The following symbols are used on the device, in these in- structions for use, on the packaging and on the type plate for the device: WARNING Indicates a potentially impending danger. If it is not avoided, death or serious injury will occur. CAUTION Indicates a potentially impending danger. If it is not avoi- ded, slight or minor injuries may occur. Product information Note on important information Observe the instructions Read the instructions before starting work and/or operating devices or machines ENGLISH Read these instructions for use carefully. Observe the warnings and safety notes. Keep these instructions for use for future reference. Make the instructions for use accessible to other users. If the device is passed on, provide the instructions for use to the next user as well.

6.5 Displaying and deleting measured values ............. 37

7. Cleaning and maintenance

Contents25 Disposal in accordance with the Waste Elec- trical and Electronic Equipment EC Directive – WEEE 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. IP20 Protected against solid foreign objects 12.5mm in diameter and larger 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

Serial number Medical device Type BF applied part Galvanically isolated applied part (F stands for “floating”); meets the requirements for leakage currents for type B26 Temperature range Humidity range Atmospheric pressure limitation Importer symbol Type number Date of manufacture

Intented 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. Intended users The blood pressure measurement is suitable for adult users whose upper arm circumference is within the range printed on the cuff. The device is also ideal for taking blood pressure measure- ments on women who are pregnant. 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.27 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 WARNING

• 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.

• Do not use the device if you are using electrical implants (e.g. pacemakers).

• Do not use the device if you have metal implants.

• 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.

• Do not use the device on people with allergies or sen- sitive skin. Undesirable side effects

General warnings WARNING

• The measurements you take are for your information only – they are not a substitute for a medical examination! Dis- cuss 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 measure- ments.

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.28

• 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 nec- essary. 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 dam- age, faults and malfunctions.

• If you have any of the following conditions, it is essential you consult your doctor before using the device: Cardiac arrhythmia, circulatory disorders, diabetes, hypotension, chills, shivering

• To rule out a difference between sides, the measurement should initially be taken on both arms.

• Never operate the device during maintenance work. Maintenance work includes maintenance, inspection and repair. General precautions CAUTION

• The blood pressure monitor is made from precision and electronic components. The accuracy of the measure- ments 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 di- rect sunlight.

• Ensure the device is at room temperature before taking a measurement. If the measuring device has been stored close to the maximum or minimum storage and trans- port 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 electro- magnetic 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 bend- ing of the cuff line.29 Notes on handling batteries WARNING

• If your skin or eyes come into contact with battery flu- id, 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 compart- ment.

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 environ- ments.

• 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/de- vice.

• 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 emis- sions or a decrease in the device’s electromagnetic im- munity; this can result in faulty operation.

Keep portable RF communication devices (including pe- ripheral equipment, such as antenna cables or external antennas) at least 30 cm away from all device parts, in- cluding all cables included in delivery.

• Failure to comply with the above can impair the perfor- mance of the device.30

4. 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 re- moved. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address.

• Blood pressure monitor

• Upper arm cuff (22-42 cm)

• Instructions for use

• Batteries, see chapter “Technical specifications”

The associated drawings are shown on page 3.

Connection for cuff con- nector (left-hand side)

Slider for user selection

Calculated pulse value

Resting indicator dis- play

Multiple measurement

Low battery indicator

• Remove the battery compartment cover on the back of the device

• Insert the batteries (see chapter “Technical specifica- tions”). Insert the batteries, making sure the polarity is correct according to the label

• Close the battery compartment cover.31 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 in- cluded 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 described in the chapter “Technical specifications”.

• Furthermore, the mains part must only be connected to the mains voltage that is specified on the type plate.

• Insert the mains adapter into the connection provided for this purpose on the rear 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 re- tained. 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 tak- en to the relevant menu automatically.

• If the batteries have already been inserted: With the device switched on, press and hold for ap- prox. three seconds. Set these settings in the order shown below: Hour format

Time Press to confirm your selection each time. Time format Time format flashes:

• Press < / > to select the time format Date The year flashes:

• Press < / > to select the year The month flashes:

• Press < / > to select the month32 The day flashes:

• Press < / > to select the day If the time format is set to the 12-hour format, the order in which the day and month are displayed is reversed. Time The hour flashes:

• Press < / > to select the hour The minutes flash:

• Press < / > to select the minutes

6.2 Before the blood pressure measure-

ment 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 suffi- ciently 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 5minutes.

• If you want to take several measurements in succession, always make sure that you leave 5 minutes 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 doc- tor 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. Place the cuff with the bottom edge approx. 2-3 cm

above your elbow. Adjust the device so that the mark and the cuff line are directly over the artery

The cuff should be fastened so that two fingers fit under the cuff when it is closed

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

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

• 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. Selecting the user This device has two users with 100 memory spaces each in order that you can save measurements from two different people separately from each other. If multiple people are using the device, make sure that the correct user has been selected before each measurement:

to set the desired user.

6.3 Taking a blood pressure measurement

Requirement: cuff attached, user selected. Measurement

1. Press . All display elements are briefly displayed.

2. The start screen welcomes you for selected

or for se- lected . From this start screen you can access all menu items, e.g. user memory.

again to start the measurement. The cuff inflates itself automatically. The measurement process starts. is displayed as soon as a pulse is detected. To cancel the measurement, press

4. The systolic pressure, diastolic pressure and pulse meas-

urements are displayed. The cuff position control symbol

is displayed throughout the entire measurement. If the cuff is too loose, and will be displayed. In such cases, the measurement is cancelled after approx. 15 sec- onds and the device switches itself off. is displayed if the measurement could not be per- formed properly. In this case, please refer to the “Trou- bleshooting” section. If necessary, re-attach the cuff after 1 minute. The device switches off automatically after approx. 30seconds. The value is saved to the selected or most recently used user. Multiple measurement

1. Press . All display elements are briefly displayed.

2. The start screen welcomes you for selected

or for se- lected . From this start screen you can access all menu items, e.g. user memory.

Multiple measurement can be selected by pressing < or >. flashes on the display. To start the measurement, confirm with . The cuff inflates itself automatically. The measurement starts.34

The device displays the first measurement cycle for 3 seconds and then performs a regular measurement that is repeated three times. In the second and third cycle, a 30-second countdown is also displayed, indicating the time to wait until the next measurement. To cancel the measurement, press

5. After the third measurement, the average measurement of

systolic pressure, diastolic pressure and pulse is displayed and indicated with . The cuff position control symbol

is displayed through- out the entire measurement. If the cuff is too loose, and will be displayed. In such cases, the measure- ment is cancelled after approx. 5 seconds and the device switches itself off. is displayed if the measurement could not be per- formed properly. In this case, please refer to the “Trou- bleshooting” section. If necessary, re-attach the cuff after 1 minute. The device switches off automatically after approx. 30seconds. The value is saved to the selected or most recently used user.

6.4 Evaluating the results

General information about blood pressure

• Blood pressure is the force with which the bloodstream presses against the arterial walls. Arterial blood pressure constantly changes in the course of a cardiac cycle.

• 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 re- laxed again and the heart is filling with blood.

• Fluctuations in blood pressure are normal. Even during repeat measurements, there may be considerable differ- ences between the measured values. One-off or irregular measurements therefore do not provide reliable informa- tion about the actual blood pressure. Reliable assess- ment is only possible when you perform the measure- ment 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.35 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 Source: The risk indicator

indicates which category the re- corded 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. Low blood pressure WARNING Low blood pressure (hypotension) can be a health hazard and cause dizziness or fainting. Blood pressure is considered low if systolic and diastolic pressure are below 90/60 mmHG (source: National Health Service, 2023). Seek medical attention if you suddenly suffer from low blood pressure. Atrial fibrillation Atrial fibrillation is one of the most common forms of cardi- ac arrhythmia and is characterised by an irregular heartbeat associated with an increased risk of stroke, heart failure and other heart complications. While the final diagnosis of atrial fibrillation can only be made by a medical examination, the Beurer AFIB technology of this device enables it to be detected with a high level of accuracy. During the blood pressure measurement, possible atrial fibril- lation is detected and displayed after the measurement with the symbol in combination with the symbol. If ar- rhythmias, such as atrial fibrillation, are present, the displayed blood pressure value may be incorrect. If the symbol is displayed after a blood pressure measurement, repeat the measurement. Rest for 5 minutes beforehand. Do not move or speak during the measurement. If the symbol appears for the first time and more frequently, please promptly consult36 your doctor. If you have previously been diagnosed with atrial fibrillation, follow your doctor’s instructions regarding what to do in the event that AFIB is detected by the device. Do not perform self-diagnosis and self-treatment based on the measurements, but rather always follow the doctor’s in- structions. 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 ob- tained 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 5minutes.

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 haemodynamical- ly unstable even in the long-term, something which persists even after repeated periods of rest. The accuracy of the re- sults for the blood pressure at rest is reduced in these users. Like any medical measurement method, the precision of HSD is limited and it can lead to incorrect results in some cases. Nevertheless, the blood pressure measurements taken when37 the user’s circulatory system is sufficiently at rest represent particularly reliable results.

6.5 Displaying and deleting measured

values User The results of every successful measurement are saved with the date and time. If there are more than 120 measurements, the oldest measurements are deleted. Press on the start screen and select the desired user using the slider. Average value is displayed: The average value of all this user’s saved measured values is displayed.

is displayed: The average value of the morning measurements for the last 7 days is displayed (morning: 5:00–9:00).

is displayed: The average value of the evening measurements for the last 7 days is displayed (evening: 18:00–20:00). Individual measured values

If you press > again, the last individual measurement is displayed (in this example, measurement 3).

/ > again, you can view the individual meas- ured values.

3. To switch the device off again, press

for approx. 2 sec- onds. Press to exit the menu. Deleting measured values

1. To delete all of a user’s saved measured values, go to the

respective user memory. The display shows and the average value of all stored measured values of this user.

2. Press and hold < and > for approx. 5 seconds.

for / for appears in the display. All values of the selected user are deleted. The device switches off automatically. Reset the device to factory settings

1. To delete all saved measured values and settings, select

the user memory. Press >. The display shows

2. Press and hold < and > for approx. 15 seconds.

appears in the display. All data stored on the device is deleted; the device is reset to factory settings. The device switches off automatically.

7. CLEANING AND MAINTENANCE

• Clean the device and cuff carefully using only a slightly damp cloth.

• Do not use any cleaning solutions or solvents.38

• 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 ob- jects 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.

REPLACEMENT PARTS Accessories and replacement parts are available on the homepage www.beurer.de, under “Service”. Please state the corresponding order number. Designation Item number and/ or order number Universal cuff 164.503 Mains adapter (EU) 072.78 Mains adapter (UK) 072.79

Error message Possible cause Solution Unable to re- cord a pulse. Please wait one minute and repeat the measurement. Ensure that you do not speak or move during the measurement. The measured blood pressure is outside the measurement range. There is a pneumatic system error. Repeat the measurement. Ensure that the cuff line is correctly connected and that you do not move or speak. An error oc- curred during the measure- ment. Please wait one minute and repeat the measurement. Ensure that you do not speak or move during the measurement.39 Error message Possible cause Solution The inflation pressure is higher than 300mmHg. Please take another meas- urement 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 nearly flat. Insert new batteries into the device.

Repairing and disposing of the device

• Do not repair or modify the device yourself. Proper oper- ation can no longer be guaranteed in this case.

• Do not open the device except for the battery compart- ment. 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. Dis- pose of the device in accordance with EC Direc- tive – WEEE (Waste Electrical and Electronic Equipment). Please contact the local authorities respon- sible for waste disposal if you have any questions regard- ing disposal. Disposal of the batteries

• Used, completely discharged batteries must not be dis- posed of with household waste. Dispose of the batter- ies 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

11. TECHNICAL SPECIFICATIONS

Type BM 53 Meas- urement method Oscillometric, non-invasive blood pressure measurement on the upper arm40 Measure- ment range Cuff pressure 300 mmHg, systolic pressure 50 – 280 mmHg, diastolic pressure 30 – 200 mmHg, pulse 40 – 199 beats/minute Display accuracy Systolic pressure ± 3 mmHg, diastolic pressure ± 3 mmHg, pulse ± 5% of the displayed value Meas- urement uncertainty Max. permissible standard deviation according to clinical testing: systolic pressure 8 mmHg, diastolic pressure 8 mmHg Memory 2 x 100 memory spaces Dimensions L 140 mm x W 94 mm x H 46 mm Weight Approx. 437 g (without batteries, with cuff) Cuff size 22 to 42 cm upper arm circumference Operating conditions + 10 °C to + 40 °C, 10 – 85 % relative humidity (non-condensing), 700 – 1060 hPa ambient pressure Storage and transport conditions -20 °C to + 55 °C, ≤ 90% relative humidity Power supply 4 x 1.5 V AAA batteries Battery life Lasts for approx. 300 measurements de- pending on the blood pressure and inflation pressure Product life cycle to be expected Information on the life cycle of the product can be found at beurer.com Classifica- tion Internal power supply, IP20 no AP or APG, continuous operation, type BF applied part The serial number is located on the device or in the battery compartment. Technical specifications are subject to change without notifi- cation to allow for updates.

This device conforms with the European stand- ard 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 sys- tems may interfere with this device.

• 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 ap- propriate means. Precise instructions for checking accu- racy may be requested from the service address. Mains part Model no. LXCP12X-050100BG Input 100 – 240 V, 50 – 60 Hz, 0.5 A max41 Output 5 V DC, 1A, in conjunction with Beurer blood pressure monitors only Manufacturer Shenzhen Iongxc power supply co., ltd. Protection This device is double protected and has a primary-side cutout switch which discon- nects the device from the mains in case of malfunction. Ensure that you have removed the batteries from the battery compartment before you use the mains part. Polarity Insulated/protection class 2 Housing and protective covers The housing of the mains part protects users from touching live parts or parts that could be live (for example with their fingers, or with a needle or checking hook). The user must not touch the patient and the output connector of the AC/DC mains part at the same time.

12. GUARANTEE/SERVICE

Further information on the guarantee and guarantee condi- tions can be found in the guarantee leaflet supplied. Notification of incidents For users/patients in the European Union and identical regulation systems (EU Medical Device Regulation (MDR) 2017/745), the following applies: If during or through use of the product a major incident occurs, notify the manufacturer and/or their representative of this as well as the respective national authority of the member state in which the user/pa- tient is located. Subject to errors and changes42