Beurer BM 55 - Upper arm blood pressure monitor Manual

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.

• Blood pressure monitor
• Upper arm cuff
• 4 x LR03 AAA batteries
• Storage bag
• USB cable
• Instructions for use

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 notice indicating a risk of injury or damage to health
	Safety note indicating possible damage to the device/accessory
Note	Note on important information
	Observe the instructions for use
	Application part, type BF
	Direct current
	Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE
	Do not dispose of batteries containing hazardous substances with household waste
PAP	Dispose of packaging in an environmentally friendly manner
	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 pressures to which the medical device can be safely exposed
	Serial number
	Device protected against foreign objects ≥ 12.5 mm and against water dripping at an angle
	This product satisfies the requirements of the applicable European and national directives.

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

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.

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, 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 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 traveling 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.
• 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, 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.
• The temperature of the cuff can reach up to 42.1°C during normal operation at an ambient temperature of 40°C.

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 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.

Device description

Blood pressure monitor and cuff

1. Cuff
2. Cuff line
3. Cuff connector
4. Connection for mains part and USB interface
5. Display
6. Memory buttons M1/M2
7. Start/stop button
8. Resting indicator display
9. Risk indicator
10. Connection for cuff connector (left-hand side)

Display

1. Date / time1
2. Systolic pressure
3. Diastolic pressure
4. Pulse value
5. Pulse symbol
6. Release air (arrow)
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

Computer interface

The blood pressure monitor also allows you to transfer your measured values to the computer.
For this, you will need a USB cable (included in delivery) and the "beurer HealthManager" computer software. The software can be downloaded free of charge from the download area under Service at www.beurer.com.

System requirements for the "beurer HealthManager" computer software

• Windows 7 SP1 or higher
• USB 2.0 (Type A) or higher

Initial use

Inserting the batteries

• Remove the battery compartment lid on the rear of the device.
• Insert four 1.5 V AAA (alkaline type LR03) batteries. Make sure that the batteries are inserted the correct way round. Do not use rechargeable batteries.
• Close the battery compartment lid again carefully.

All display elements are briefly displayed, flashes in the display. Set the date and time as described below.

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

Making settings

This menu allows you to set the following functions, one after another.

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.

If you press and hold the M1 or M2 memory button, you can set the values more quickly.

Hour format

• Press and hold the Start/stop button for 5 seconds.
  
• Choose the desired hour format with the M1/M2 memory buttons and confirm with the Start/stop button .
  

Date

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.

Time

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 .
  

Operation with the mains part

You can also operate this device with a mains part. When doing so, there must not be any batteries in the battery compartment. The mains part can be obtained from specialist retailers or from the service address using order number 071.95.

• To prevent possible damage to the device, the blood pressure monitor must only be used with the mains part described here.
• Insert the mains part into the connection provided for this purpose on the blood pressure monitor. The mains part must only be connected to the mains voltage that is specified on the type plate.
• 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 measurements are retained.

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
163.946*	Universal cuff	22-42 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

Measurement

• To start the blood pressure monitor, press the Start/stop button . All display elements are briefly displayed.

The blood pressure monitor will begin the measurement automatically after 3 seconds.
The cuff automatically inflates.

Measuring can be cancelled at any time by pressing the Start/stop button .

The cuff's air pressure is slowly released. If you already recognise a tendency for high blood pressure, you should reinflate the cuff and increase the cuff's pressure again. As soon as a pulse is found, the pulse symbol is displayed.

• Systolic pressure, diastolic pressure and pulse measurements are displayed.
• A symbol at the bottom of the display also lights up to indicate whether you were sufficiently relaxed during the blood pressure measurement (green symbol = sufficiently at rest; red symbol = not at rest).
• Observe the chapter on interpreting results/measuring the resting indicator in these instructions for use.
• appears if the measurement could not be performed properly. Observe the chapter on error messages/troubleshooting in these instructions for use and repeat the measurement.
  
• 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 or 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. one minute. In this case too, the value is stored in the selected or most recently used user memory.
• Wait for at least 1 minute before taking another measurement.
  

Evaluating 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)

Measuring the resting indicator (using the HSD diagnosis)

The most frequent error made when measuring blood pressure is taking the measurement when not at rest (haemodynamic stability), which means that both the systolic and the diastolic blood pressures are distorted.
While measuring the blood pressure, the device automatically determines whether you are at rest or not.

GREEN: Haemodynamic stability

Measurement of the systolic and diastolic pressure is increased when the circulatory system is sufficiently at rest and is a very reliable indicator of resting blood pressure.
The blood pressure measurement must be taken when the patient is physically and mentally rested, as it will be the basis for diagnosing the blood pressure level and regulating the patient's medical treatment. The blood pressure measurements taken when the circulatory system was at rest represent particularly reliable results.

RED: Lack of haemodynamic stability

It is very probable that the systolic and diastolic blood pressures have not been measured whilst the patient is at rest and the resting blood pressure measurement has therefore been distorted.
Repeat the measurement after a rest and relaxation period of at least five minutes. Go to a sufficiently quiet and comfortable spot and remain there calmly; close your eyes, breathe deeply and evenly and try to relax.
If the next measurement also shows insufficient stability, you can repeat the measurement after another resting period. If the measurements continue to show some instability, identify these blood pressure measurements as having been taken when the circulatory system had not been sufficiently rested. In this case, nervousness or inner anxiety may be the cause and this cannot be cured by brief periods of rest. Existing cardiac arrhythmias may also prevent a stable blood pressure measurement. The accuracy of the resting blood pressure results is reduced in these users. Like any medical measurement method, the precision of the HSD diagnosis is limited and can lead to incorrect results in some cases.

Saving, displaying and deleting measured values

User memory

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 .
• Within 3 seconds of the full-screen display appearing, select the desired user memory ( ) with the M1 or M2 memory button.
  • To view the measurements for user memory , press the M1 memory button.
  • To view the measurements for user memory , press the M2 memory button.

Your last measurement will appear on the display.

Average values

• 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.).
  

Individual measured values

• 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 .

You can exit the menu at any time by pressing the Start/stop button .

Deleting measured values

• 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.

Transferring measurements

Connect the blood pressure monitor to your PC using the USB cable.

No data transfer may be launched whilst performing a measurement.

is shown on the display. Begin the data transfer in the "beurer HealthManager" PC software. During the data transfer, an animation is shown on the display. A successful data transfer is displayed as in figure 1.

If the data transfer is unsuccessful, an error message appears as in figure 2.

In this case, interrupt the PC connection and start the data transfer again.

After 30 seconds of not being in use or if communication with the PC is interrupted, the blood pressure monitor switches itself off automatically.

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.

Designation	Item number and/or order number
Universal cuff (22-42 cm)	163.946
Mains part (EU)	071.95
USB cable	163.484

What if there are problems?

Error message	Possible cause	Solution
	The systolic pressure could not be recorded correctly.	Repeat the measurement. Ensure that you do not move or speak.
	The diastolic pressure could not be recorded correctly.
	The systolic and diastolic pressures are above the measurement range.
	The systolic and diastolic pressures are below the measurement range.
	The cuff has been fastened too tightly.	Repeat the measurement. Ensure that you do not move or speak
	The cuff has been fastened too loosely.
	The inflation pressure is higher than 300 mmHg or the measured blood pressure is outside of the measurement range.
	Pumping up is taking longer than 160 seconds.
	There is a system or device error.
	The batteries are almost empty.	Reinsert the batteries or replace with new batteries.
	Unable to send the data to the PC.	Check there is a connection to the PC and repeat the process.

Technical alarm – description

Should the recorded blood pressure (systolic or diastolic) lie outside the limits specified in the section "Technical specifications", the technical alarm will appear on the display indicating either " " or "". In such cases, you should seek medical assistance and check the accuracy of your procedure. The limit values for the technical alarm are factory set and cannot be adjusted or deactivated. These alarm limit values are accorded second priority under the standard IEC 60601-1-8. The technical alarm is a non-locking alarm and must not be reset. The signal shown on the display will disappear automatically after about 8 seconds.

Specifications

Model no.	BM 55
Type	M1002
Measurement method	Oscillometric, non-invasive blood pressure measurement on the upper arm
Measurement range	Cuff pressure 0 – 300 mmHg, systolic 60– 260 mmHg, diastolic 40 –199 mmHg, Pulse 40 –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 186 mm x W 95 mm x H 56 mm
Weight	Approx. 467 g (without batteries)
Cuff size	22 to 42 cm
Permissible operating conditions	+10°C to + 40°C, ≤ 90% relative air humidity (non-condensing)
Permissible storage and transport conditions	20°C to + 55°C, ≤ 90% relative air humidity, 800 –1050 hPa ambient pressure
Power supply	4 x 1.5 V AAA batteries
Battery life	For approx. 200 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

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.

Mains part

Model no.	LXCP12-006060BEH
Input	100 – 240 V, 50 – 60 Hz, 0.5 A max
Output	6 V DC, 600 mA, only in connection with beurer blood pressure monitor.
Supplier	Shenzhen Iongxc power supply co., ltd
Protection	This device is double insulated and protected against short circuit and overload by a primary thermal fuse. Make sure to take the batteries out of the compartment before using the mains adapter.
	Polarity of the the DC voltage connection
	Double insulated / equipment class 2
Enclosures and Protective Covers	Equipment enclosed to protect against contact with live parts, and with parts which can become live (finger, pin, hook test). The operator shall not contact the patient and the output plug of AC mains adapter simultaneously.

Documents / Resources

References

• Beurer — Beurer North America

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