BC 87 - Blood pressure monitor BEURER - Free user manual and instructions

USER MANUAL BC 87 BEURER

Table of contents Read these instructions for use carefully and keep them for later use. Make them accessible to other users and note the information they contain.

1. 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 acces- sories 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. 1 x wrist blood pressure monitor with cu 1 x instructions for use 1 x quick guide 1 x storage box 2 x 1.5 V LR03 AAA batteries23

2. SIGNS AND SYMBOLS

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 Warning notice indicating a risk of injury or damage to health Important Safety note indicating possible damage to the device/accessory Product information Note on important information Observe the instructions Read the instructions before starting work and/or operating devices or machines Isolation of applied parts, type BF Galvanically isolated application part (F stands for “floating”); meets the require- ments for leakage currents for type B Direct current The device is suitable for use with direct current only Disposal Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE Battery disposal Do not dispose of batteries containing harmful substances with household waste Separate the packaging elements and dispose of them in accordance with local regulations.

Marking to identify the packaging material. A = material abbreviation, B = material number: 1-6 = plastics, 20-22 = paper and cardboard Separate the product and packaging ele- ments and dispose of them in accordance with local regulations. Manufacturer Temperature limit The temperature limit values to which the medical device can safely be exposed are indicated Humidity, limit Indicates the humidity range to which the medical device can safely be exposed IP class Device protected against foreign objects ≥ 12.5mm and against water dripping at an angle24

Serial number Item number Medical device CE labelling This product satisfies the requirements of the applicable European and national directives. Authorised representative in the European Community

Purpose The blood pressure monitor is intended for the fully automat- ic, non-invasive measurement of arterial blood pressure and pulse values on a wrist with a wrist circumference of 13.5 cm to 21.5 cm. It is intended for use indoors and by adults only. Target group It is designed for self-measurement by adults in the home en- vironment and is suitable for users whose wrist circumference is within the range printed on the cu. Indication/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. The device saves the recorded measurements and can also output average values of previ- ous measurements.

• Do not use the blood pressure monitor on newborns, chil- dren or pets.

• People with restricted physical, sensory or mental skills should be supervised by a person responsible for their safety and receive instructions from this 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: irregu- lar heartbeat, circulatory problems, diabetes, pregnancy, pre-eclampsia, hypotension, chills, shaking

• People with pacemakers or other electrical implants should consult their doctor before using the device.

• The blood pressure monitor must not be used in connec- tion with a high-frequency surgical unit.

• Do not use the cu on people who have undergone a mastectomy.

• Do not place the cu over wounds as this may cause further injury.

• Make sure that the cu is not placed on a wrist in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or intravascular therapy, or an arteriovenous (AV) shunt.25 General warnings

• The measurements taken by you are for your information only – they are no substitute for a medical examination! Discuss the measured values with your doctor and never make your own medical decisions based on them (e.g. regarding dosages of medicines).

• 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 en- vironment or whilst on the move (e.g. whilst travelling in a car, ambulance or helicopter, or whilst undertaking physi- cal activity such as playing sport) can influence the meas- urement accuracy and cause incorrect measurements.

• Cardiovascular diseases may lead to incorrect measure- ments or have a detrimental eect on measurement ac- curacy.

• Do not use the device at the same time as other medical electrical devices (ME equipment). This could lead to a malfunction of the measuring device 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 cus included in delivery or cus described in these instructions for use for the device. Using another cu may lead to measurement inaccuracies.

• Note that when inflating the cu, the functions of the limb in question may be impaired.

• Do not perform measurements more frequently than nec- essary. Due to the restriction of blood flow, some bruising may occur.

• During the blood pressure measurement, the blood cir- culation must not be stopped for an unnecessarily long time. If the device malfunctions, remove the cu from the wrist.

• Place the cu on your wrist only. Do not place the cu on other parts of the body.

• Small parts may present a choking hazard for small chil- dren if swallowed. They should therefore always be su- pervised. General precautions

• 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 from impacts, moisture, dirt, marked temperature fluctuations and direct sunlight.

• Ensure the device is at room temperature before measur- ing. If the measuring device has been stored close to the maximum or minimum storage and transport tempera- tures 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 drop the device.

• Do not use the device in the vicinity of strong electro- magnetic fields and keep it away from radio systems or mobile telephones.26

• We recommend that the batteries be removed if the de- vice will not be used for a prolonged period of time. Measures for handling batteries

• If your skin or eyes come into contact with battery fluid, rinse the aected areas with water and seek medical assistance.

• Choking hazard! Small children may swallow and choke on batteries. Therefore, batteries should be stored out of the reach of small children.

• 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.

• Protect batteries from excessive heat.

• Do not charge or short-circuit the batteries.

• If the device is not 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

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

• The use of the device may be limited 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 de- vice 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 other than those specified or pro- vided 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.

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

5. DEVICE DESCRIPTION

The corresponding drawings are shown on page 3.

Battery compartment lid

START/STOP button with integrated position indicator27 Information on the display: The corresponding drawings are shown on page 3.

Calculated pulse rate

Symbol for irregular heartbeat Symbol for pulse

Symbol for Bluetooth

• Remove the battery compartment lid on the left side of the device

• Insert two 1.5 V AAA micro (alkaline type LR03) batteries. Make sure that the batteries are inserted the correct way round in accordance with the markings

. Do not use rechargeable batteries.

• Close the battery compartment lid again carefully.

• flashes on the display. Now set the date and time as described below. If the battery change symbol is flashing and appears, no further measurements are possible and you must replace all batteries. Once the batteries have been removed from the device, the date and time must be set again. Any saved measured values are retained. Adjusting the settings You must make sure that the device has the correct settings before use in order to be able to make full use of all functions. Only by doing so can your measurements with associated date and time be saved and accessed later by you. There are two dierent ways to access the menu from which you can adjust the settings:

• 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 o press and hold the START/ STOP button for approx. 5 seconds. In this menu you can adjust the following settings in succes- sion: Hour format Date Time User28 Hour format The hour format flashes on the display.

• Select the desired hour format using the M1 or M2 memory button and confirm with the START/STOP button . Date The year flashes on the display.

• Select the desired year using the M1 or M2 memory button and confirm with the START/STOP button . The month flashes on the display.

• Select the desired month using the M1 or M2 memory button and confirm with the START/ STOP button

The day flashes on the display.

If the hour format is set as , the day/month display sequence is reversed. Time The hours flash on the display.

• Select the desired hour using the M1 or M2 memory button and confirm with the START/ STOP button . The minutes flash on the display.

• Select the desired minute using the M1 or M2 memory button and confirm with the START/ STOP button

symbol is shown on the display.

data transfer should be activated (Bluetooth

symbol is shown) or deactivated (Bluetooth

symbol is not shown) and confirm with the START/STOP button .

has been ac- tivated, data transfer is started automatically after the measurement. Bluetooth

transfers will reduce the battery life. User The user symbol flashes in the display.

• Use the M1 or M2 memory button to select the desired user.

• Confirm your selection with the START/STOP button .

• The device then switches o automatically.29

General information about blood pressure

• Blood pressure is always stated in the form of two values:

• The highest pressure is systolic blood pressure. This aris- es when the heart muscle contracts and blood is pumped into the blood vessels.

• The lowest pressure is diastolic blood pressure. This aris- es when the heart muscle has completely stretched back out and the heart fills with blood.

• Fluctuations in blood pressure are normal. Even during repeat measurements, considerable dierences between the measured values may occur. One-o 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. Attaching the cu

• Fundamentally, blood pressure can be measured on both wrists. Certain deviations between the measured blood pressure on the right wrist and left wrist are due to physiological causes and completely normal. You should always perform the measurement on the wrist with the highest blood pressure values. Before starting self-meas- urement, consult your doctor in this regard. From this point on, always take measurements on the same wrist.

• The device may only be operated with the cu attached when supplied. Before using the device, the user should check the fit of the cu and, in doing so, ensure that their wrist circumference is within the range printed on the cu.

• Uncover your wrist. Ensure that the circulation of the wrist is not hindered by tight clothing or similar.

• Now place the cu on the wrist so that the palm of your hand and the device display are facing upwards B 1

• Position the cu so that there is a distance of 1.0 – 1.5 cm between it and the heel of your hand B 2

• Now fasten the cu tightly around your wrist using the hook-and-loop fastener. Make sure that it is tight but that it does not cut into your wrist B 3

Adopting the correct posture

• To carry out a blood pressure measurement, make sure you are sitting upright and comfortably. Lean back so your back is supported.

• Place your arm on a surface

• Place your feet flat on the ground next to one another.

• The cu must be level with your heart.

• Stay as still as possible during the measurement and do not speak. Position indicator As an additional application aid, the device has a position in- dicator built into the START/STOP button . This is intended to help you determine the correct measuring position of the device at heart level and depends on the angle of observa- tion.30 Display Interpretation Position indicator is coloured red

You have not yet reached the recom- mended position of the measuring device at heart level – your wrist is either positioned too high or too low. Position indicator is coloured green; the word “OK” also appears

You have reached the recommended position of the measuring device at heart level and can start the measure- ment by pressing the START/STOP button . In the vast majority of use cases, the position indicator pro- vides an excellent guide as to whether the measuring device is at heart level. Due to physical dierences such as size and/ or physique on the user side, this function may not be helpful in all cases. If you feel that the wrist position according to the position indicator does not match the level of the heart, use your own judgement. You can also start the measurement in these cases at any time by pressing the START/STOP but- ton

Selecting the user This device has 2 user memories with 120 memory spaces each in order that you can save measurements from 2 dier- ent people separately from each other. If multiple people are using the device, make sure that the relevant user is set before each measurement. Please refer to the section “Adjusting the settings” for infor- mation on how to select the desired user. Performing the blood pressure measurement Measurement Press the START/STOP button to start the blood pressure monitor. All display elements are briefly displayed.

• The blood pressure monitor will begin the measurement automatically after approx. 3 seconds.

• The cu inflates automatically while the actual measure- ment process starts. As soon as a pulse is found, the pulse symbol is displayed. You can cancel the measurement at any time by pressing the START/STOP button .

• The remaining air is released quickly once the measure- ment is complete.

• Systolic pressure, diastolic pressure and pulse measure- ments are displayed. A symbol in the display also ap- pears which shows you whether you were suciently relaxed during the blood pressure measurement or not

symbol = suciently at rest;

symbol = not at rest). Observe the chapter on evaluating results/resting indicator measurement in these instructions for use.

• Press the START/STOP button to switch o the blood pressure monitor. The measurement is then stored in the selected user memory.

• appears if the measurement could not be performed properly. In this case, please read the section “What if there are problems?”.31

function has been activated, the data transfer to the “beurer HealthManager Pro” app starts automatically after the measurement.

symbol flashes on the display. The device now attempts to connect to the app for approx. 30sec- onds.

symbol stops flashing as soon as a con- nection is established. All measurement data is trans- ferred to the apps. Once the data transfer is successfully complete, the device switches o automatically.

• If a connection to the smartphone cannot be established after 30 seconds, the Bluetooth

symbol goes out and the device switches o automatically after 1minute.

• If you forget to turn o the device, it will switch o au- tomatically after approx. 1 minute. In this case too, the value is stored in the selected or most recently used user memory. Transfer of measurements via Bluetooth

In addition to displaying and saving your measurements lo- cally on the device, you have the option of transferring your measurements to your smartphone using Bluetooth

low en- ergy technology. For this, you will need the “beurer HealthManager Pro” app. These apps are available for free in the Apple App Store and from Google Play. System requirements: List of compatible devices: - iOS ≥ 12.0 / Android™ ≥ 8.0 - Bluetooth

≥ 4.0 To transfer the measured values, proceed as follows: Step 1: BC87 Activate the Bluetooth

function on your device as described in the “Adjusting the settings” section. Step 2: “beurer HealthManager Pro” app In the “beurer HealthManager Pro” app, add the BC87 under Settings / Devices and follow the instructions. Step 3: BC87 Take a measurement.32 Step 4: BC87 (Data transfer imme- diately following the measurement): If the Bluetooth

function is activated, data will be automatically transferred after the measurement. Step 4: BC87 (Data transfer at a later point): Go into the memory recall mode for the desired user memory (see “Saving, accessing and deleting measured values”). The data transfer starts auto- matically. Also note the following information:

• When connecting for the first time, a randomly generated six-digit PIN code is displayed on the device, and at the same time an input field appears on the smartphone in which you must enter this six-digit PIN code. After suc- cessfully entering the code, the device will be connected to your smartphone.

• Ensure that the “beurer HealthManager Pro” app on your smartphone is always activated and launched when you start the data transfer on the device.

• You can tell that the data transfer is in progress by the Bluetooth

• If your smartphone has a protective cover, remove it to ensure that there is no interference during the transfer. 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 in the cycle is called systolic blood pressure. This arises when the heart muscle contracts and blood is pumped into the blood vessels. - The lowest is diastolic blood pressure, which is when the heart muscle has completely stretched back out and the heart fills with blood.

• Fluctuations in blood pressure are normal. Even during repeat measurements, considerable dierences between the measured values may occur. One-o 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. Risk indicator The World Health Organization (WHO) has defined the in- ternationally recognised classification for the evaluation of measured blood pressure values listed in the table below:33 Measured blood pressure value range Classification Colour of the risk indicator Systole (in mmHg) Diastole (in mmHg) ≥ 180 ≥ 110 High blood pressure stage 3 (severe) Red 160 – 179 100 – 109 High blood pressure stage 2 (moderate) Orange 140 – 159 90 – 99 High blood pressure stage 1 (mild) Yellow 130 – 139 85 – 89 High normal Green 120 – 129 80 – 84 Normal Green < 120 < 80 Optimal Green Source: WHO, 1999 (World Health Organization) The risk indicator (the arrow in the display and the associ- ated scale on the device) shows which category the recorded blood pressure values fall into. If the measured values are in two dierent classifications (e.g. systole in the high normal category and diastole in the normal category), the risk indica- tor then always shows you the higher category – “high nor- mal” in the example described. Please be aware that these standard values can only serve as a general guideline, as the individual blood pressure varies in dierent people and dierent age groups, etc. Furthermore, it must be noted that measurements taken your- self while at home are generally lower than those that are taken by the doctor. For this reason, it is important that you regularly consult your doctor for advice. Only they are able to give you your personal target values for controlled blood pressure – in particular if you receive medicinal therapy. Irregular heartbeat This device can identify any irregular heartbeat disturbances as part of the analysis of your recorded pulse signal during blood pressure measurement. In this case, after the measure- ment, the device will indicate any irregularities in your pulse by displaying the symbol in the display. This can be an indicator for irregular heartbeat. If the symbol appears on the display after the measure- ment, the measurement must be repeated as the measure- ment accuracy may be impaired. To assess your blood pres- sure, only use the results that have been recorded without corresponding irregularities in your pulse. If the symbol appears frequently, please consult your doctor. Only they can establish the existence of an arrhythmia during a checkup, using their means of diagnosis. Resting indicator One of the most common errors made when taking a blood pressure measurement is not ensuring that the user’s circula- tory system is suciently at rest when taking the measure- ment. In this case, the measured systolic and diastolic blood pressure values do not correspond to 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.34 This enables it to indicate whether the blood pressure was taken when the user’s circulatory system was suciently at rest.

The measured blood pressure value was ob- tained when the user’s circulatory system was suciently at rest and reliably corresponds to the blood pressure at rest.

Indicates that the value was obtained when the user’s circulatory system was not suciently at rest. The blood pressure values measured in this case generally do not correspond to 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 dis- played During the measurement it was not possible to determine whether the user’s circulatory system was suciently at rest. In this case too, the measurement should be repeated after a period of rest lasting at least 5 minutes. If the user’s circulatory system was not suciently at rest, this can be caused by various factors such as physical or mental strain or distraction, speaking, or experiencing irregular heart- beat 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 taking a blood pressure measurement. However, certain patients suering from irregular heartbeat or chronic mental conditions may remain haemodynamically un- stable 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 HSD is limited and can lead to incorrect results in some cases. Nevertheless, the blood pressure measurements taken when the user’s circulatory system is suciently at rest represent particularly reliable results. Saving, accessing and deleting measured values User memory The results of every successful measurement are stored to- gether with the date and time. The oldest measurement is overwritten in the event of more than 120 measurements.

• To select the relevant user memory, press the memory button M1 (for user ) or M2 (for user memory ) when the device is switched o. Then confirm your selection by pressing the START/STOP button .

is activated (the symbol flashes on the display), the blood pressure monitor attempts to connect to the app. The buttons are deactivated and the symbol ceases to flash as soon as a connection is established and the data is transferred. If you press the M1 or M2 memory button during this pro- cess, the transfer is cancelled. The symbol is no longer shown.35 Average values Press the M1 memory button. Then confirm your selection by pressing the START/STOP button .

• is shown in the display.

• The average value of all saved measured values in this user memory is displayed. Press the M1 memory button.

is shown in the display.

• The average value of the morning meas- urements for the last 7 days is displayed (morning: 5 a.m. – 9 a.m.). Press the M1 memory button.

is shown in the display.

• The average value of the evening meas- urements for the last 7 days is displayed (evening: 6 p.m. – 8 p.m.). Individual measured values

• When you press the memory button M1 again, the last individual measurement is displayed (in this example, measurement 03).

• When you press the memory button M1 again, you can view your individual measurements.

• To switch the device o again, press the START/STOP button . Deleting measured values

• In order to delete a user memory, first select the user memory to be deleted by pressing the M1 or M2 memory button when the device is switched o and confirming your selection by pressing the START/STOP button .

• The average value of all measurements for the selected user memory appears on the display; at the same time lights up on the display.

• Now press and hold the memory buttons M1 and M2 at the same time for 5 seconds. appears on the display. All the values in the selected user memory have now been deleted. You can exit the menu at any time by pressing the START/STOP button .

8. CLEANING AND MAINTENANCE

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

• Do not use any cleaning agents or solvents.

• Under no circumstances hold the device and cu under water, as this can cause liquid to enter and damage the device and cu.

Error mes- sage Possible cause Solution Unable to record a pulse. Please wait one minute and repeat the measure ment. Ensure that you do not speak or move during the measurement. You moved or spoke during the measure- ment. The cu is not at- tached correctly. Please observe the information in chapter “Attaching the cu” and take another measure- ment after one minute. An error occurred during the measure- ment. Please wait one minute and repeat the measure ment. Ensure that you do not speak or move during the measurement. If the error occurs repeatedly, consult a doctor to check you are healthy. Error mes- sage Possible cause Solution The inflation pres- sure is higher than 300mmHg. Please take another measurement to check whether the cu can be correctly inflated. The measured values are outside the specified measure- ment range. The batteries are almost empty. Insert new batteries into the device. Unable to transfer the data via Bluetooth

Please observe the in- formation in the section “Transfer of measure- ments via Bluetooth

A device error has occurred. Please wait one minute and repeat the meas- urement. If the problem still occurs despite the suggested corrective actions, please contact Customer Services.37

Repairing and disposing of the device

• Do not repair or adjust the device yourself. Proper opera- tion can no longer be guaranteed in this case.

• Do not open the device. Failure to comply with this in- struction will void the warranty.

• Repairs must only be carried out by Customer Services or authorised retailers. Before making a claim, please check the batteries first and replace them if necessary.

• For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. 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). If you have any questions, please contact the local authorities re- sponsible for waste disposal. Disposing of the batteries

• Batteries must not be disposed of in the household waste. They may contain poisonous heavy metals and are subject to special refuse treatment.

• 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

Model no. BC87 Measurement method Oscillometric, non-invasive blood pressure measurement on the wrist Measurement range Cu pressure 0-299 mmHg, systolic 60-230 mmHg, diastolic 40-130 mmHg, pulse 40-199 beats/minute Display accuracy Systolic ± 3 mmHg, diastolic ± 3 mmHg, pulse ± 5% of the value shown Measurement uncertainty Max. permissible standard deviation according to clinical testing: systolic 8 mmHg / diastolic 8 mmHg Memory 2 x 120 memory spaces Dimensions L 72 mm x W 96 mm x H 71 mm Weight Approximately 119 g (without batteries, with cu) Cu size 135 to 215 mm Permissible operating conditions +5°C to +40°C, 15-90% relative humidity (non-condensing), 700-1060 hPa ambient air pressure Permissible storage and transport conditions -20°C to +60°C, ≤ 93% relative humidity38 Power supply 2 x 1.5 V AAA batteries Battery life For approx. 200 measurements, depending on blood pressure and inflation pressure levels Classification Internal supply, IP22, no AP or APG, continuous operation, application part type BF Software version A01 Data transfer 2402 MHz – 2480MHz frequency band Max. -2.5 dBm transmission power The blood pressure monitor uses Bluetooth

low energy technology Compatible with Bluetooth

≥ 4.0 smartphones/tablets The serial 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 complies with the European stand- ard EN 60601-1-2 (in compliance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8) and is subject to special precautionary measures with regard to electromagnetic compatibility. Please note that portable and mobile HF communication systems may interfere with this device.

• This device complies with EU Directive 93/42/EEC con- cerning medical devices, the Medizinproduktegesetz (German Medical Devices Act) and IEC 80601-2-30 (Medical electrical equipment – Part 2-30: Particular re- quirements for basic safety and essential performance of automated non-invasive sphygmomanometers).

• The accuracy of the blood pressure monitor has been carefully checked. No calibration is required.

• The device has been developed with regard to a long useful life. The expected operating life is 5 years.

• 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.

• We hereby confirm that this product complies with the European RED Directive 2014/53/EU. The CE Decla- ration of Conformity for this product can be found at: www.beurer.com/web/we-landingpages/de/cedeclara- tionofconformity.php

12. WARRANTY/SERVICE

Further information on the warranty and warranty condi- tions can be found in the warranty leaflet supplied. Subject to errors and changes39 FRANÇAIS

Symbol for Bluetooth

Symbol for Bluetooth

Tarkempia tietoja takuusta ja takuuehdoista löytyy muka- na toimitetusta takuulomakkeesta. Pidätämme oikeuden muutoksiin, emmekä vastaa mahdollisista virheistä232 EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Warning Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equip- ment should be observed to verify that they are operating normally. Warning Use of accessories, transducers and cables other than those specified or provided by the manufac- turer of this equipment could result in increased electromagnetic emissions or decreased electro- magnetic immunity of this equipment and result in improper operation. Warning Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment BC 87, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Technical description

1. 1 all necessary instructions for maintaining BASIC SAFE-

TY and ESSENTIAL PERFORMANCE with regard to elec- tromagnetic disturbances for the excepted service life.

2. Guidance and manufacturer’s declaration -electromag-

netic emissions and Immunity Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions

Not applicable Voltage fluctuations/ flicker emissions

Not applicable233 Table 2 Guidance and manufacturer’s declaration – electro- magnetic Immunity Immunity test IEC 60601-1-2 Test level Compliance level Electrostatic discharge (ESD)

Not applicable Not applicable Surge

Not applicable Not applicable Voltage dips, short interrup- tions and volta- ge variations on power supply input lines

Not applicable Not applicable Power frequen- cy magnetic field

Not applicable Not applicable Radiated RF

is the a.c. mains voltage prior to application of the test level.234 Table 3 Guidance and manufacturer’s declaration - electromagnetic Immunity Radiated RF

(Test speci- fications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment) Test Frequency (MHz) Band (MHz) Service Modulation Modulation (W) Distance (m) IMMUNITY TEST LEVEL (V/m) 385 380-390 TETRA

word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Beurer GmbH is under license. Other trademarks and trade names are those of their respective owners. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S. and other countries. Google Play and the Google Play logo are trademarks of Google LLC. Android is a trademark of Google LLC. Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Medical Device Safety Service GmbH, Schigraben41, 30175 Hannover, Germany BEURER GmbH, Söflinger Str. 218, 89077 Ulm (Germany) www.beurer.com, www.beurer-blutdruck.de www.beurer-gesundheitsratgeber.com, www.beurer-healthguide.com