BC 54 - Blood pressure monitor BEURER - Free user manual and instructions

USER MANUAL BC 54 BEURER

Table of contents Read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain. Dear customer, thank you for choosing a product from our range. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, body temperature, pulse, gentle therapy, massage, beauty and air. With kind regards, your Beurer team24

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 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 Service address. 1 x Wrist blood pressure monitor with cu 1 x Instructions for use 1 x Quick Start Guide 1 x Storage box 2 x 1.5V AAA batteries LR03

2. 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: WARNING Warning instruction indicating a risk of in

jury or damage to health CAUTION Safety note indicating possible damage to the device/accessory Product information Note on important information Observe the instructions Read the instructions before start

ing 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 in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE Do not dispose of batteries containing hazardous 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 code, B = Material number: 1-7 = Plastics, 20-22 = Paper and cardboard25 Separate the product and packaging elements and dispose of them in ac

cordance 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. Atmospheric pressure, limit Indicates the range of atmospheric pres

sures to which the medical device can be safely exposed IP22 IP class Device protected against foreign objects ≥ 12.5 mm and against water dripping at an angle

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

Intended use The blood pressure monitor is intended for the fully auto- matic, non-invasive measurement of arterial blood pres- sure and pulse values on the wrist. Target group It is designed for self-measurement by adults in the home environment and is suitable for users whose wrist circum- ference is within the range printed on the cu. Indication/clinical benefits The user can record their blood pressure and pulse val- ues quickly and easily using the device. The recorded values are classified according to internationally appli- cable guidelines and evaluated graphically. Furthermore, the device can detect any irregular heart beats that occur during measurement and inform the user via a symbol in the display. The device saves the recorded measure- ments and can also output average values of previous measurements. The recorded data can provide healthcare service provid- ers with support during the diagnosis and treatment of blood pressure problems, and therefore plays a part in the long-term monitoring of the user’s health.26

4. Warnings and safety notes

o not use the blood pressure monitor on newborns, children or pets.

eople 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.

f you have any of the following conditions, it is essen- tial you consult your doctor before using the device: cardiac arrhythmia, circulatory problems, diabetes, pregnancy, pre-eclampsia, hypotension, chills, shak- ing.

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

he blood pressure monitor must not be used in con- nection with a high-frequency surgical unit.

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

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

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

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

he 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.

sing the blood pressure monitor outside your home environment or whilst on the move (e.g. whilst travelling in a car, ambulance or helicopter, or whilst undertaking physical activity such as playing sport) can influence the measurement accuracy and cause incorrect meas- urements.

ardiovascular diseases may lead to incorrect meas- urements or have a detrimental eect on measurement accuracy.

o not use the device at the same time as other medi- cal electrical devices (ME equipment). This could lead to a malfunction of the measuring device and/or an in- accurate measurement.

o not use the device outside of the specified storage and operating conditions. This could lead to incorrect measurements.27

• 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 bruis- ing may occur.

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

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

he 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 care- ful handling.

rotect the device from impacts, moisture, dirt, marked temperature fluctuations and direct sunlight.

nsure the device is at room temperature before meas- uring. 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.

o not drop the device.

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

e recommend that the batteries be removed if the device will not be used for a prolonged period of time. Measures for handling batteries

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

hoking hazard! Small children may swallow and choke on batteries. Therefore, store batteries out of the reach of small children.

isk of explosion! Do not throw batteries into a fire.

f a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.

o not disassemble, open or crush the batteries.

rotect batteries from excessive heat.

f the device is not to be used for a long period of time, remove the batteries from the battery com- partment.28

se identical or equivalent battery types only.

lways 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 envi- ronments.

• 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 dis- play/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 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 re- sult in faulty operation.

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

6. Battery compartment lid

2. Symbol for Bluetooth

5. Diastolic pressure

average value ( A A ), morning ( AM AM ), evening ( PM PM )

• 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. Do not use rechargeable batteries.

lose the battery compartment lid again carefully. 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. Making settings You must make sure that the device has the correct set- tings 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.30 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: Press and hold the START/STOP button on the device when switched o for approx. 5 seconds. In this menu you can adjust the following settings in suc- cession: Hour format

It is essential to set the date and time. Otherwise, you will not be able to save your measured values correctly with a date and time and access them again later. Hour format The hour format now flashes on the display.

elect the desired hour format us- ing the memory button M1 or M2 and confirm with the START/STOP button . Date The year flashes on the display.

elect the desired year using the memory button M1 or M2 and con- firm with the START/STOP button

elect the desired month using the memory button M1 or M2 and con- firm with the START/STOP button

The day flashes on the display.

elect the desired day using the memory button M1 or M2 and con- firm with the START/STOP button

If the hour format is set as , the day/month display sequence is reversed.31 Time The hours flash on the display.

elect the desired hour using the memory button M1 or M2 and con- firm with the START/STOP button

The minutes flash on the display.

elect the desired minute using the memory button M1 or M2 and confirm with the START/STOP button . Bluetooth

symbol is shown in the display.

data transfer is activated (Bluetooth

symbol is displayed) or de- activated (Bluetooth

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

transfers will reduce the battery life.

General rules when measuring blood pressure yourself

n order to generate as informative a profile of the progression of your blood pressure as possible and ensure that the measured values can be compared, you should measure your blood pressure regularly and always at the same times of day. It is recom- mended that you measure your blood pressure twice a day: once in the morning after getting up and once in the evening.

ou should always carry out the measurement when you are suciently physically rested. You should therefore avoid taking measurements during stress- ful periods.

o not take a measurement within 30 minutes of eating, drinking, smoking or exercising.

efore the initial blood pressure measurement, make sure always to rest for about 5 minutes.

urthermore, if you want to take several measure- ments in succession, make sure always to wait for at least 1 minute between the individual measure- ments.

epeat the measurement if you are unsure of the measured value.32 Attaching the cu

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

he device may only be operated with the cu at- tached 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.

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

ow place the cu on the wrist so that the palm of your hand and the device display are facing upwards.

osition the cu so that there is a distance of 1.0 – 1.5cm between it and the heel of your hand.

ow 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. Adopting the correct posture

o carry out a blood pressure measurement, make sure you are sitting upright and comfortably. Lean back and place your arm on a surface. Do not cross your legs. Place your feet next to each other flat on the floor.

lways make sure that the device is at heart level dur- ing the measurement. Otherwise significant measure- ment deviations can occur due to physiological causes. To do so, place your elbow on a table to sup- port your arm. In order to make the measurement even more comforta- ble for you, you can place your lower arm on a suitable object (e.g. the storage box).

elax your arm and the palm of your hand.

o avoid distorting the measurement, you should re- main as still as possible during the measurement and not speak.

• • • • • • • • • • • • •33 Selecting the user You have 2 memories, each with 60 memory spaces, to enable the separate storage of measurements for 2 dif- ferent people. To select the corresponding user memory, press the M1 memory button (for user ) or M2 (for user ) on the switched-o device. Confirm your selection by pressing the START/STOP button . Performing the blood pressure measurement As described above, attach the cu and adopt the pos- ture in which you want to perform the measurement.

start the blood pressure monitor. All displays will illuminate briefly. The blood pressure monitor will begin the measurement automatically after 5 seconds. The cu automatically inflates. The measurement itself is taken during the inflation phase. As soon as a pulse is found, the pulse symbol is dis- played. You can cancel the measurement at any time by pressing the START/STOP button .

• The systolic pressure, diastolic pres- sure and pulse rate measurements are displayed.

appears if the measurement could not be performed properly. Observe the chapter „9. What if there are prob- lems?“ in these instructions for use and repeat the measurement.

• Press the START/STOP button to switch o the blood pressure monitor. The measure- ment is then stored in the selected user memory. If Bluetooth

data transfer is activated, data is trans- ferred after pressing the START/STOP button

symbol flashes on the dis- play. The blood pressure monitor now attempts to connect to the app for approx. 30 seconds. The Bluetooth

symbol stops flashing as soon as a connection is established. All measurement data is au- tomatically transferred to the app. Once the data has been successfully transferred, the device switches o.

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

symbol goes out and the

blood pressure monitor switches off automatically after 5 seconds.

• If you forget to turn o the device, it will switch o au- tomatically. In this case too, the value is stored in the selected or most recently used user memory. 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.

lood pressure is always stated in the form of two val- ues: – 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 ves- sels. – The lowest is diastolic blood pressure, which is when the heart muscle has completely stretched back out and the heart fills with blood.

luctuations in blood pressure are normal. Even dur- ing repeat measurements, considerable dierences between the measured values may occur. One-o or irregular measurements therefore do not provide reli- able information about the actual blood pressure. Reli- able assessment is only possible when you perform the measurement 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: 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 as- sociated 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 cate- gory), the risk indicator then always shows you the higher category – “high normal” in the example described.35 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 yourself 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. Cardiac arrhythmia This device can identify any cardiac rhythm disturbances as part of the analysis of your recorded pulse signal dur- ing blood pressure measurement. In this case, after the measurement, the device will indicate any irregularities in your pulse by displaying the symbol in the display. This can be an indicator for arrhythmia. Arrhythmia is an illness in which the heart rhythm is abnormal because of flaws in the bioelectrical system that regulates the heart- beat. The symptoms (skipped or premature heart beats, pulse being slow or too fast) can be caused by factors such as heart disease, age, physical disposition, excess alcohol and tobacco, stress or lack of sleep. If the symbol appears on the display after the measurement, the measurement must be repeated as the measurement 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 sym- bol appears frequently, please consult your doctor. Only they can establish the existence of an arrhythmia during a checkup, using their means of diagnosis. Saving, displaying and deleting measured values User memory The results of every successful measurement are stored together with the date and time. The oldest measurement is overwritten in the event of more than 60 measurements.

• To select the corresponding user memory, press the M1 memory button (for user ) or M2 (for user ) on the switched-o device. Confirm your selec- tion 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 connec- tion is established and the data is transferred. If you press the memory button M1 or M2 in the meantime, the transfer is cancelled. The symbol is no longer shown.36 Average values

is displayed. The average value of all saved measured values in this user memory is displayed.

• Press the memory button M1. AMAM is displayed. The average value of the morning meas- urements for the last 7 days is displayed (morning: 5.00 a.m. – 9.00 a.m.).

• Press the memory button M1. PMPM is displayed. The average value of the evening meas- urements for the last 7 days is displayed (evening: 6.00 p.m. – 8.00 p.m.). Individual measured values

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

• If you press the memory button M1 once more, you can view your individual measured values.

o switch the device o again, press the START/ STOP button . You can exit the menu at any time by pressing the START/STOP button

Delete the measured values

• To erase a user's memory, first select the user mem- ory to be erased by pressing the M1 or M2 memory button on the o device and confirm your selection by pressing the START/STOP button .

• The average value of all measurements appears on the display; in parallel,

• Press and hold down both memory buttons M1 and M2 simultaneously for 5 seconds. [L 00[L 00 appears on the display. All the val- ues in the selected user memory have now been deleted.37 Transfer via Bluetooth

It is also possible to transfer the measured values saved on the device to your smartphone via Bluetooth

You will need the “ beurer Health Manager” app for this. This is available in the Apple App Store and from Google Play. System requirements for the app “beurer Health Manager”:

≥ 4.0 List of compatible devices: Proceed as follows to transfer values: If Bluetooth

is activated in the settings menu, the data is transferred automatically after the measurement. The symbol appears in the top left of the display (see chapter „6. Initial use“, section “Bluetooth

When connecting for the first time, a randomly-gen- erated six-digit PIN code is displayed on device, and at the same time an input field appears on the smart- phone in which you must enter this six-digit PIN code. After successfully entering the code, the device will be connected to your smartphone. Step 1: BC 54 Activate Bluetooth

on your device (see chapter „6. Initial use“, section “Bluetooth

Step 2: “ beurer Health Manager” app In the “ beurer Health Manager” app, add the BC 54 under “Settings/My devices”. Step 3: BC 54 Take a measurement.38 Step 4: BC 54: Data transfer immediately following measurements.

data transfer has been ac- tivated, data is trans- ferred after having confirmed the user memory and pressing the START/STOP but- ton

Step 4: BC 54: Data transfer at a later point:

transfer starts automatically. The “ beurer Health Manager” app must be active to allow data transfer. If your smartphone has a protective cover, remove this to ensure that there is no interference during the transfer. Begin the data transfer in the “ beurer Health Manager” app. We would explicitly draw attention to the fact that the software to hand is not a medical product in accordance with EU Directive 93/42/EEC. The values displayed are purely for visualisation purposes and must not be used as a basis for therapeutic treat- ments. The software is not part of a diagnostic-medical system.

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.

• If you store the device and cu, do not place heavy objects on the device and cu. Remove the batteries.

9. What if there are problems?

Error message Possible cause Solution Unable to re- cord a pulse. Please wait one minute and repeat the measu- rement. Ensure that you do not speak or move during the measurement. You have mo- ved or spoken during the measurement.39 Error message Possible cause Solution The cu was not attached correctly. Please observe the notes in chapter "7. Usage" under the section "Atta- ching the cu". During a new measure- ment, check whether the cu can now be inflated properly.

An error oc- curred during measurement. Please wait one minute and repeat the measu- rement. Ensure that you do not speak or move during the measurement.

The inflation pressure is higher than 300 mmHg or the measured blood pressure is outside the measuring range.

The batteries are almost empty. Insert new batteries into the device. Error message Possible cause Solution

The data could not be sent via Bluetooth

Proceed as described in chapter „7. Usage“ under the section „Transfer via Blue- tooth

“ into the manual memory mode and try to restart the data transfer.

A device error has occurred. Please repeat the mea- surement after a pause of one minute. If the problems persist despite the proposed corrective actions, please contact customer service.

Repairing and disposing of the device

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

• Do not open the device. Failure to comply will result in voiding of the warranty.

• Repairs must only be carried out by Customer Services or authorised suppliers. Before making a claim, please check the batteries first and replace them if necessary.40

• For environmental reasons, do not dispose of the de- vice in the household waste at the end of its useful life. Dispose of the unit at a suitable local collection or recycling point. Dispose of the de- vice in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal. Disposing of the batteries

• Batteries must not be disposed of with household waste. They may contain toxic heavy metals and are subject to special waste treatment.

he 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. BC54 Measurement method Oscillometric, non-invasive blood pressure measurement on the wrist Measurement range Cuff 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 inaccuracy Max. permissible standard deviation according to clinical testing: Systolic 8 mmHg / Diastolic 8 mmHg Memory 2 x 60 memory spaces Dimensions L 80.5 mm x W 69.5 mm x H 25 mm Weight Approximately 116 g (without batteries, with cuff) Cuff size 135 to 215 mm Permissible operat

ing conditions +5 °C to +40 °C, 15-90 % relative humidity (non-condensing), 700-1060 hPa ambient pressure Permissible storage and transport conditions -20 °C to +60 °C, ≤ 93% relative humidity (non-condensing) Power supply 2 x 1.5V AAA batteries Battery life For approx. 150 measurements, de

pending on levels of blood pressure and pump pressure Software version A0141 Data transfer 2402 MHz – 2480 MHz frequency band Transmission power max. 7 dBm The blood pressure monitor uses Blue- tooth

low energy technology Compatible with Bluetooth

smartphones/tablets The serial number is located on the device or in the bat- tery compartment. Technical information is subject to change without notifi- cation to allow for updates.

• This device is in line with European Standard EN 60601-1-2 (In accordance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3 and IEC 61000-4-8) and is subject to particular precautions with regard to electromagnetic compatibility (EMC). Please note that portable and mobile HF communication systems may interfere with this unit.

• This device corresponds to the EU Medical Devices Directive 93/42/EEC, the German Medical Devices Act (Medizinproduktgesetz) and the standards EN 1060-1 (non-invasive sphygmomanometers, Part 1: General requirements), EN 1060-3 (non-invasive sphygmoma- nometers, Part3: Supplementary requirements for elec- tro-mechanical blood pressure measuring systems) and IEC 80601-2-30 (Medical electrical equipment –

Part 2-30: Particular requirements for the basic safety

and essential performance of automated non-invasive sphygmomanometers).

• The accuracy of this blood pressure monitor has been carefully checked. Calibration is not necessary.

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

• If using the device 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 Declara- tion of Conformity for this product can be found under: www.beurer.com/web/we-landingpages/de/cedecla- rationofconformity.php

12. Warranty / Service

Further information on the guarantee and guarantee conditions can be found in the guarantee leaflet sup- plied. Subject to errors and changes42 FRANÇAIS

Warning: Don’t near active HF surgical equipment and

the RF shielded room of an ME system for magnetic re- sonance 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 equipment 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 manufactu- rer of this equipment could result in increased electroma- gnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

Warning: Portable RF communications equipment (inclu-

ding peripherals such as antenna cables and external an- tennas) should be used no closer than 30 cm (12 inches) to any part of the equipment (BC 54), including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. If any: a list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to aect compliance of the ME EQUIP- MENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTU- RER and EQUIPMENT OR TYPE REFERENCE). If any: the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need not be used).167 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 application Voltage fluctuations/ flicker emissions

Not application Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity Immunity test IEC 60601-2 test level Compliance level Electrostatic discharge (ESD)

±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air Electrical fast transient/burst

line(s) to line(s): ±1 kV line(s) to earth: ±2 kV 100 kHz repetiti-

frequency Not application168 Voltage dips, short interrup- tions and volta- ge variations on power supply input lines

; 25/30 cycles Single phase: at 0° 0% U

150KHz to 80MHz: 3Vrms 6Vrms (in ISM and amateur ra- dio bands) 80% Am at 1kHz Not application Radiated RF

is the a.c. mains voltage prior to application of the test level.169 Table 3 Guidance and manufacturer’s declaration - electromagnetic immunity Radiated RF IEC61000-4- 3 (Test specifica- tions for ENCLOSU- RE PORT IMMUNITY

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. BEURER GmbH