beurer BM 45 Upper Arm Blood Pressure Monitor Instruction Manual

beurer BM 45 Upper Arm Blood Pressure Monitor Instruction Manual

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 is synonymous with high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, body temperature, pulse, gentle therapy, massage, beauty, baby and air.

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 contents and contact your retailer or the specified Customer Service address.

• 1x blood pressure monitor
• 1x upper arm cuff (22-36 cm)
• 1x instructions for use
• 4x 1.5V AA LR6 batteries
• 1x storage bag

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 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 requirements for leakage currents for type BF
| 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 cardboard
| Separate the product and packaging elements and dispose of them in accordance with local regulations.
| Manufacturer
Storage/Transport
| Permissible storage and transport temperature and humidity
Operating
| Permissible operating temperature and humidity
| Keep dry / Protect from moisture
| Serial number
| Item number
| Medical device
| CE labelling
This product satisfies the requirements of the applicable European and national directives

Intended use

Intended use

The blood pressure monitor is intended for the fully automatic, non-invasive measurement of arterial blood pressure and pulse values on the upper arm.

Target group

It is designed for self-measurement by adults in the home environment and is suitable for users whose upper arm 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 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 measurements and can also output average values of previous measurements.

The recorded data can provide healthcare service providers with support during the diagnosis and treatment of blood pressure problems, and therefore plays a part in the long-term monitoring of the user’s health.

Warnings and safety notes

Contraindications

• Do not use the blood pressure monitor on newborns, 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: cardiac arrhythmia, circulatory problems, diabetes, pregnancy, preeclampsia, 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 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

• The measured values 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 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.
• Please 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 arm.
• Place the cuff on your upper arm only. Do not place the cuff on other parts of the body.
• The air line poses a risk of strangulation for small children. Furthermore, included small parts pose a risk of suffocation 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, humidity, 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 electromagnetic fields and keep it away from radio systems or mobile telephones.
• We recommend that the batteries be removed if the device is not to be used for a prolonged period of time.
• Avoid any mechanical restriction, compression or bending of the cuff line.

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, store batteries 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 the batteries from excessive heat.
• Do not charge or short-circuit batteries.
• If the device is not to be used for a relatively long period, take the batteries out of 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 orstacked 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.

Device description

Blood pressure monitor and cuff

1. Cuff
2. Cuff line
3. Cuff connector
4. Connection for mains part* (rear of device)
5. Display
6. Memory buttons M1 / M2
7. Start/stop button
8. Risk indicator
9. Connection for cuff connector (left-hand side)

• not included in delivery

Information on the display:

1. Date/time
2. Systolic pressure
3. Diastolic pressure
4. Calculated pulse value
5. Pulse symbol
6. Release air
7. Number of memory space/memory display average value , morning , evening
8. Battery replacement symbol
9. User memory
10. Risk indicator
11. Cardiac arrhythmia symbol
    

Initial use

Inserting the battery

• Open the battery compartment lid.

• Insert four 1.5 V AA (alkaline type LR6) batteries. Make sure that the batteries are inserted the correct way round in accordance with the markings. Do not use rechargeable batteries.
  4 x 1,5V AA (LR6)
  

• Carefully close the battery compartment lid again.

• All display elements are briefly displayed, 24h flashes in the display. Now set the date and time as described below.

If the low battery indicator is permanently displayed, you can no longer perform any measurements and must replace the batteries. Once the batteries have been removed from the device, the time must be set again. Any saved measured values are retained

Operation with the mains part

You can alternatively also operate this device with a mains part (not included in delivery). However, before connecting the device with the mains part, please ensure that you have removed the batteries from the device. During mains operation, there must not be any batteries in the battery compartment, as this could damage the device.

• To avoid any potential damage, the device may only be operated with a mains part that meets the specifications described in the chapter “Technical specifications”.
• Furthermore, the mains part must only be connected to the mains voltage that is specified on the type plate.
• First, remove the protective cap of the mains part connector – located on the rear of the device – and insert the mains part into the connection intended for this purpose
• Then insert the mains plug of the mains part into the mains socket.
• After using the blood pressure monitor, unplug the mains part from the mains socket first and then disconnect it from the blood pressure monitor. As soon as you unplug the mains part, the blood pressure monitor loses the date and time setting but the saved measured values are retained.

Setting the hour format, date and time

It is essential that you 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.

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 hour format now flashes on the display.

• Choose the desired hour format with the M1 / M2 memory buttons and confirm with the Start/ stop button .

The year flashes on the display.

• Choose the desired year with the M1/M2 memory buttons and confirm with the Start/ stop button .

The month flashes on the display.

• Choose the desired month with the M1/M2 memory buttons and confirm with the Start/ stop button .

The day flashes on the display.

• Choose the desired day with the M1 / M2 memory buttons and confirm with the Start/ stop button .
  If the hour format is set as 12h, the day/month display sequence is reversed.

The hour flashes on the display.

• Choose the desired hour with the M1/M2 memory buttons and confirm with the Start/stop button .

The minute flashes on the display.

• Choose the desired minute with the M1/M2 memory buttons and confirm with the Start/stop button .

Usage

General rules when measuring blood pressure yourself

• In 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 recommended that you measure your blood pressure twice a day: once in the morning after getting up and once in the evening.
• You should always carry out the measurement when you are sufficiently physically rested. You should therefore avoid taking measurements during stressful periods.
• Do not take a measurement within 30 minutes of eating, drinking, smoking or exercising.
• Before the initial blood pressure measurement, make sure always to rest for 5 minutes.
• Furthermore, if you want to take several measurements in succession, make sure always to wait for at least 1 minute between the individual measurements.
• Repeat the measurement if you are unsure of the measured value.

Attaching the cuff

• Fundamentally, 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

• The device may only be operated with one of the following cuffs. This should be selected in accordance with your upper arm circumference. The fit should be checked before measurement using the index mark described below.
  Ref. no.| Designation| Arm circumference
  ---|---|---
  163.388*| Standard cuff| 22-36 cm
  163.387| XL cuff| 35-44 cm

  • Included in standard delivery

• Place the cuff onto the bare upper arm. The circulation of the arm must not be hindered by tight clothing or similar.
  

• The cuff must be placed on the upper arm so that the bottom edge is positioned 2-3 cm above the elbow and over the artery. The line should point to the centre of the palm here.
  

• Guide the end of the cuff that is sticking out through the metal ring, fold it back over the arm and close the cuff using the hook-and-loop fastener. The cuff should be fastened tightly, but not too tightly, so that two fingers can still fit under the closed cuff.
  

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

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

Adopting the correct posture

• To 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.
  

• Always make sure that the cuff is at heart level.

• To avoid distorting the measurement, you should remain as still as possible during the measurement and not speak.
  

Performing the blood pressure measurement

• To start the blood pressure monitor, press the Start/stop button . All displays will illuminate briefly.

• The blood pressure monitor will begin the measurement automatically after approx. 3 seconds. The cuff inflates as the first step.
  Measuring can be cancelled at any time by pressing the Start/stop button .

• Then the air pressure in the cuff is slowly released. Now the measurement starts. As soon as a pulse is found, the pulse symbol is displayed.

• If a tendency towards high blood pressure can already be identified, it is possible that the cuff may inflate again to a higher pressure level whilst the air is being released.

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

• Systolic pressure, diastolic pressure and pulse measurements are displayed.

• E__ appears if the measurement has not been performed properly. In this case, please read the section “What if there are problems?”.

• Now select the desired user memory by pressing the M1 or M2 memory buttons. If you do not select a user memory, the measurement is stored in the most recently used user memory. The relevant symbol M1 or M2 appears on the display.

• Using the Start/stop button , switch off the blood pressure monitor. The measurement is then stored in the selected user memory. If you forget to turn off the device, it will switch off automatically after approx. 3 minutes. 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.
• 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

Cardiac arrhythmia

This device can identify potential disruptions of the heart rhythm when measuring and, if necessary, indicates this after the measurement with the symbol . 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 heartbeat. The symptoms (skipped or premature heart beats, pulse being slow or too fast) can be caused by factors such as heart disease, age, physical makeup, excess stimulants, stress or lack of sleep. Arrhythmia can only be determined through an examination by your doctor. If the symbol appears frequently, please consult your doctor. Only they are able to determine any arrythmia during an examination.

Risk indicator

The measurements can be classified and evaluated in accordance with the following table.

However, these standard values serve only as a general guideline, as the individual blood pressure varies in different people and different age groups etc.

It is important to consult your doctor regularly for advice. Your doctor will tell you your individual values for normal blood pressure as well as the value above which your blood pressure is classified as dangerous.

The bar chart on the display and the scale on the device show which category the recorded blood pressure values fall into. If the values of systole and diastole fall into two different categories (e.g. systole in the high normal category and diastole in the normal category), the graphical classification on the device always shows the higher category; for the example given this would be high normal.

Blood pressure value category| Systole
(in mmHg)| Diastole
(in mmHg)| Action
---|---|---|---
Level 3:
severe hypertension| red| ≥180| ≥110| Seek medical attention
Level 2:
moderate hypertension| orange| 160–179| 100–109| Seek medical attention
Level 1:
mild hypertension| yellow| 140–159| 90–99| Regular monitoring by doctor
High normal| green| 130–139| 85–89| Regular monitoring by doctor
Normal| green| 120–129| 80–84| Self-monitoring
Optimal| green| <120| <80| Self-monitoring

Source: WHO, 1999 (World Health Organization)

Saving, accessing and deleting measured values

The results of every successful measurement are stored together with the date and time. If there are more than 60 measurements, the oldest measurements are lost.

• To access memory recall mode, the blood pressure monitor must first be started. To do this press the Start/stop button .

• After the full-screen display, select the relevant user memory that you want to see the measurement data for within 3 seconds using the M1 or M2 memory button ( M1 for or M2 for ).

• Your last measurement will appear on the display.

• Press the relevant memory button ( M1 or M2 ).
  If you have selected user memory1, the M1 memory button must be pressed.
  If you have selected user memory2, the M2 memory button must be pressed.

flashes on the display.
The average value of all saved measured values in this user memory is displayed.

• Press the relevant memory button (M1 or M2). flashes on the display.
  The average value of the morning measurements for the last 7 days is displayed (morning: 5.00 a.m. – 9.00 a.m.).

• Press the relevant memory button (M1 or M2). flashes on the display.
  The average value of the evening measurements for the last 7 days is displayed (evening: 6.00 p.m. – 8.00 p.m.).

• When the relevant memory button ( M1 or M2 ) is pressed again, the last individual measurement is displayed (in this example, measurement 03).

• When the relevant memory button ( M1 or M2 ) is pressed again, you can view your individual measurements.

• To switch the device off again, press the Start/stop button
  or wait 30 sec.
  You can exit the menu at any time by pressing the Start/ stop button .

• To clear the memory of the relevant user memory, you must first select a user memory.

• Start individual measurement access.

• Press and hold the M1 & M2 memory buttons for 5 seconds.

• All the values in the current user memory are deleted.

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. The cuff line should not be bent sharply.

Accessories and replacement parts

Accessories and replacement parts are available from the corresponding service address (according to the service address list). Please state the corresponding order number.

What if there are problems?

measurement. Ensure that you do not speak or move during the measurement
| You moved or spoke during the measurement.
| The cuff was not attached correctly| Please observe the information in chapter “Attaching the cuff”.
| An error occurred during the measurement.| Please wait one minute and repeat the measurement. Ensure that you do not speak or move during the measurement.
| The inflation pressure is higher than 300 mmHg.| Please take another measurement to check whether the cuff can be correctly inflated. Make sure that neither your arm nor other heavy objects are pressing on the line, and that the line is not bent.

| The batteries are almost empty.| Insert new batteries into the device.

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 will invalidate 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 household waste at the end of its service 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

• The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.
• The codes below are printed on batteries containing harmful substances:
  • Pb = Battery contains lead,
  • Cd = Battery contains cadmium,
  • Hg = Battery contains mercury.

Technical specifications

Device

the upper arm
Measurement range| Cuff pressure 0–300 mmHg, systolic 60–250 mmHg, diastolic 40–199 mmHg, Pulse 30–180 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 160 mm x W 107 mm x H 50 mm
Weight| Approx. 408 g (without batteries, with cuff)
Cuff size| 22 to 44 cm
Permissible operating conditions| +5°C to +40°C, 15–90% relative air humidity (non-condensing)
Permissible storage and transport conditions| -25°C to +70°C, ≤93% relative air humidity, 700hPa–1060hPa ambient pressure
Power supply| 4x 1,5 V AA batteries
Battery life| For approx. 250 measurements, depending on the blood pressure level and/or pump pressure
Classification| Internal supply, IPX0, no AP or APG, continuous operation, application part type BF (cuff), CLASS II (when using a mains part)

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 unit is in line with European Standard EN 60601-1-2 (In accordance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-6 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 complies with 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 sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and IEC 80601-2-30 (Medical electrical equipment – Part 230: 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 and developed with regard to a long useful life. If the device is used for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address.

Mains part

only
Manufacturer| Shenzhen Iongxc power supply co., ltd.
Protection| This device is double protected and has a primary-side cutout switch which disconnects the device from the mains in case of malfunction. Ensure that you have removed the batteries from the battery compartment before you use the mains part.
| Polarity of the DC voltage connection
| Insulated/protection class 2
Housing and protective covers| The housing of the mains part protects users from touching live parts or parts that could be live (for example with their fingers, or with a needle or checking hook). The user must not touch the patient and the output connector of the AC/DC mains part at the same time.

Warranty/service

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

Beurer GmbH
Söflinger Straße 218
89077 Ulm, Germany
www.beurer.com
www.beurer-gesundheitsratgeber.com
www.beurer-healthguide.com

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