beurer BC 87 Wrist Blood Pressure Monitor Instruction Manual

beurer BC 87 Wrist Blood Pressure Monitor Instruction Manual

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 accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address.

1 x wrist blood pressure monitor with cuff
1 x instructions for use
1 x quick guide
1 x storage box
2 x 1.5 V LR03 AAA batteries

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:

3. INTENDED USE

Purpose
The blood pressure monitor is intended for the fully automatic, 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 environment and is suitable for users whose wrist circumference is within the range printed on the cuff.

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

4. WARNINGS AND SAFETY NOTES

Contraindications

• Do not use the blood pressure monitor on new-borns, children 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: irregular 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 connection with a high-frequency surgical unit.
• 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 a wrist in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or intravascular therapy, or an arteriovenous (AV) shunt. and evaluated graphically. The device saves the recorded measurements and can also output average values of previous measurements.

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 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 measurements.
• Cardiovascular diseases may lead to incorrect measurements 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 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 cuffs included in delivery or cuffs described in these instructions for use for the device. Using another cuff may lead to measurement inaccuracies.
• Note that when inflating the cuff, the functions of the limb in question may be impaired.
• Do not perform measurements more frequently than necessary. Due to the restriction of blood flow, some bruising may occur.
• During the blood pressure measurement, the blood circulation must not be stopped for an unnecessarily long time. If the device malfunctions, remove the cuff from the wrist.
• Place the cuff on your wrist only. Do not place the cuff on other parts of the body.
• Small parts may present a choking hazard for small children if swallowed. They should therefore always be supervised.

General precautions

• The blood pressure monitor is made from precision and electronic components. The accuracy of the measurements and service life of the device depend on its careful handling.
• Protect the device from impacts, moisture, dirt, marked temperature fluctuations and direct sunlight.
• Ensure the device is at room temperature before measuring. If the measuring device has been stored close to the maximum or minimum storage and transport temperatures and is placed in an environment with a temperature of 20°C, it is recommended that you wait approx. 2 hours before using the measuring device.
• Do not 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.
• We recommend that the batteries be removed if the device 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 affected 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 environments.
• 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/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 result in faulty operation.
• Failure to comply with the above can impair the performance of the device.

5. DEVICE DESCRIPTION

The corresponding drawings are shown on page 3.

1. Risk indicator
2. Display
3. Memory button M1
4. START/STOP button with integrated position indicator
5. Memory button M2
6. Battery compartment lid
7. Wrist cuff

Information on the display:
The corresponding drawings are shown on page 3.

6. INITIAL USE

Inserting the batteries

• Remove the battery compartment lid on the left side of the device A .
• 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 (A) . Do not use rechargeable batteries.
• Close the battery compartment lid again carefully.
• 24h flashes on the display. Now set the date and time as described below. If the battery change symbol is flashing and BRE L0 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 different 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 off press and hold the START/ STOP button for approx. 5 seconds.

In this menu you can adjust the following settings in succession:

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

Bluetooth®
The Bluetooth® symbol is shown on the display.

• Use the M1 or M2 memory button to select whether automatic Bluetooth® data transfer should be activated (Bluetooth® symbol is shown) or deactivated (Bluetooth® symbol is not shown) and confirm with the START/STOP button .
• If automatic data transfer via Bluetooth® has been activated, data transfer is started automatically after the measurement.
  (i) 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 off automatically.

7. USAGE

General information about blood pressure

• Blood pressure is always stated in the form of two values:
• The highest pressure is systolic blood pressure. This arises when the heart muscle contracts and blood is pumped into the blood vessels.
• The lowest pressure is diastolic blood pressure. This arises 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 differences between the measured values may occur. One-off or irregular measurements therefore do not provide reliable information about the actual blood pressure. Reliable assessment is only possible when you perform the measurement regularly under comparable conditions.

Attaching the cuff

• 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-measurement, 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 cuff attached when supplied. Before using the device, the user should check the fit of the cuff and, in doing so, ensure that their wrist circumference is within the range printed on the cuff.
• Uncover your wrist. Ensure that the circulation of the wrist is not hindered by tight clothing or similar.
• Now place the cuff on the wrist so that the palm of your hand and the device display are facing upwards (B 1) .
• Position the cuff 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 cuff 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 (C) .
• 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 speak.

Position indicator
As an additional application aid, the device has a position indicator 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 observation.

In the vast majority of use cases, the position indicator provides an excellent guide as to whether the measuring device is at heart level. Due to physical differences 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 button .

Selecting the user
This device has 2 user memories with 120 memory spaces each in order that you can save measurements from 2 different 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 information 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 cuff inflates automatically while the actual measurement process starts. As soon as a pulse is found, the pulse symbol is displayed.
  (i) You can cancel the measurement at any time by pressing the START/STOP button .

• The remaining air is released quickly once the measurement is complete.

• Systolic pressure, diastolic pressure and pulse measurements are displayed. A symbol in the display also appears which shows you whether you were sufficiently relaxed during the blood pressure measurement or not ( symbol = sufficiently at rest; 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 off the blood pressure monitor. The measurement is then stored in the selected user memory.

• Er4 appears if the measurement could not be performed properly. In this case, please read the section “What if there are problems?”.

• If the Bluetooth® function has been activated, the data transfer to the “Beurer Health Manager Pro” app starts automatically after the measurement.

• The Bluetooth® symbol flashes on the display. The device 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 transferred to the apps. Once the data transfer is successfully complete, the device switches off automatically.

• If a connection to the smartphone cannot be established after 30 seconds, the Bluetooth® symbol goes out and the device switches off automatically after 1 minute.

• If you forget to turn off the device, it will switch off automatically 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 locally on the device, you have the option of transferring your measurements to your smartphone using Bluetooth® low energy technology. For this, you will need the “Beurer Health Manager Pro” app. These apps are available for free in the Apple App Store and from Google Play.

System requirements:
– iOS 12.0 / Android™ 8.0
– Bluetooth® 4.0

List of compatible devices:

https://www.beurer.com/verwaltung/redirect.php?hash=4216e1501838325

To transfer the measured values, proceed as follows:

(i) 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 successfully 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® symbol shown on the display.
• 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 differences between the measured values may occur. One-off or irregular measurements therefore do not provide reliable information about the actual blood pressure. Reliable assessment is only possible when you perform the measurement regularly under comparable conditions.

Risk indicator
The World Health Organization (WHO) has defined the internationally recognised classification for the evaluation of measured blood pressure values listed in the table below:

Source: WHO, 1999 (World Health Organization)

The risk indicator (the arrow in the display and the associated scale on the device) shows which category the recorded blood pressure values fall into. If the measured values are in two different classifications (e.g. systole in the high normal category and diastole in the normal category), the risk indicator then always shows you the higher category ­ “high normal” 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 different people and different 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.

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 measurement, 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 measurement, the measurement must be repeated as the measurement accuracy may be impaired. To assess your blood pressure, 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 check-up, 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 circulatory system is sufficiently at rest when taking the measurement. 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 haemodynamic 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

If the user’s circulatory system was not sufficiently at rest, this can be caused by various factors such as physical or mental strain or distraction, speaking, or experiencing irregular heartbeat 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 suffering from irregular heartbeat or chronic mental conditions may remain hemodynamically unstable even in the long-term, something which persists even after repeated periods of rest. The accuracy of the results for the blood pressure at rest is reduced in these users. Like any medical measurement method, the precision of 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 sufficiently at rest represent particularly reliable results.

Saving, accessing and deleting measured values

User memory

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 off 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. (i) You can exit the menu at any time by pressing the START / STOP button .

8. CLEANING AND MAINTENANCE

• Clean the device and cuff carefully using a slightly damp cloth only.
• Do not use any cleaning agents or solvents.
• Under no circumstances hold the device and cuff under water, as this can cause liquid to enter and damage the device and cuff.
• If you store the device and cuff, do not place heavy objects on the device and cuff. Remove the batteries.

9. REMEDY

If the problem still occurs despite the suggested corrective actions, please contact Customer Services.

10. DISPOSAL

Repairing and disposing of the device

• Do not repair or adjust the device yourself. Proper operation can no longer be guaranteed in this case.
• Do not open the device. Failure to comply with this instruction 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 responsible 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

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 standard 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 concerning medical devices, the Medizinproduktegesetz (German Medical Devices Act) and IEC 80601-2-30
  (Medical electrical equipment – Part 2-30: Particular requirements 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 Declaration of Conformity for this product can be found at:
  www.beurer.com/web/we- landingpages/de/cedeclarationofconformity.php

12. WARRANTY/SERVICE

Further information on the warranty and warranty conditions can be found in the warranty leaflet supplied.
Subject to errors and changes

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 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 manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic 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 SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity

www.beurer.com, www.beurer- blutdruck.de
www.beurer-gesundheitsratgeber.com,
www.beurer-healthguide.com

References

• Beurer GmbH | Gesundheit und Wohlbefinden
• Was ist Blutdruck?
• Beurer Gesundheitsratgeber
• Beurer Health Guide
• Beurer GmbH | Health and wellbeing
• Beurer — Beurer North America
• beurer.com/web/
• Beurer GmbH | Gesundheit und Wohlbefinden
• Beurer GmbH | Gesundheit und Wohlbefinden
• Beurer GmbH | Gesundheit und Wohlbefinden
• Beurer GmbH | Gesundheit und Wohlbefinden
• Beurer GmbH | Gesundheit und Wohlbefinden

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