Beurer BM 58 - Upper arm blood pressure monitor Manual

Included in delivery

Blood pressure monitor
Upper arm cuff
USB cable
4 x LR6 AA batteries
Storage bag
Instructions for use

Getting to know your instrument

Check that the device packaging has not been tampered with 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.
The upper arm blood pressure monitor is used for non-invasive measurement and monitoring of adults' arterial blood pressure. You can use it to measure your blood pressure quickly and easily, storing the results and displaying the progression of readings together with the average. A warning is issued for anyone suffering from cardiac arrhythmia.
The recorded values are classified and evaluated graphically.
Store these instructions for use for future reference and make them accessible to other users.

Signs and symbols

The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and accessories:

	Attention
	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
	Dispose of packaging in an environmentally friendly manner
	Manufacturer
	Permissible storage and transport temperature and humidity
	Permissible operating temperature and humidity.
	Protect from moisture
	Serial number
	The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products.

Unit description

1. Cuff tube
2. Cuff
3. Cuff connector
4. Touch screen activation switch
5. USB interface
6. Cuff holder
7. Cuff connector port
   (left side)
8. Memory button MEM
9. START/STOP button
10. Mains part port
11. Display

Touch screen activation switch

The device features a touch screen display. To prevent the screen from being activated accidentally, keep the touch screen activation switch set to OFF when the device is not in use. To operate the device, move the touch screen activation switch to ON. When the touch screen display is touched (START/STOP button or MEM button), a beep is output. Tip: You can switch off the device at any time by setting the touch screen activation switch to the OFF position.

Cuff holder

Thanks to the cuff holder on the underside of the device, you have the option of conveniently storing the cuff. To do so, push out the cuff holder with both thumbs until it locks into place (see also Chapter: Inserting battery).

Icons in the display

1. Time and date
2. Systolic pressure
3. Diastolic pressure
4. Measured pulse
5. Release air (arrow)
6. Memory display, average value (), morning (), evening ()
7. Risk indicator
8. "Change battery" icon
9. Arrhythmia recognition

PC interface

The blood pressure monitor also allows you to transfer your measured values to the computer.
For this, you will need a standard 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" PC software

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

Prepare measurement

Inserting battery

• Push the cuff holder upwards at the rear of the device until it locks into place.
• Open the battery compartment lid.
• Insert four AA 1.5 V alkaline batteries. making absolutely sure that you insert them with the correct polarity as marked. Never use rechargeable batteries.
• Replace the battery cover carefully.

If the battery change is continuously illuminated, measurement is no longer possible and you must replace all the batteries. Once batteries have been removed from the device, the time must be reset.
Used batteries do not belong in the household waste. You are legally obliged to dispose of the batteries. Dispose of them via your specialist electrical supplier or local collec ting point for recyclable waste.

Setting date and time

You should set the date and time without fail. Otherwise, you will not be able to save your measured values correctly with a date and time and to access them again later.
Tip: If you press and hold the MEM button, you can set the values more quickly.
To set the date and time, proceed as follows:

• Move the touch screen activation switch to the ON position.
• Press the START/STOP and MEM buttons simultaneously, 24h begins to flash. Select 12h or 24h mode using the MEM button. Press START/STOP to confirm your selection. The year display will start to flash. Set the year with the MEM button and confirm with START/STOP .
• Then set the month, day, hour and minutes and confirm each setting with START/STOP .
• Pressing the START/STOP button again will switch the display off.

Note: In 24h mode, the date is displayed as day/month. In 12h mode, as month/day.

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 right-hand side of 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.

Measuring blood pressure

Ensure the device is at room temperature before measuring. The measurement can be performed on the left or right arm.

Attaching the cuff

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.

Now tighten the free end of the cuff, but make sure that it is not too tight around the arm and close the hook-and-loop fastener. The cuff should be fastened so that two fingers can fit under the cuff.

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

This cuff is suitable for you if the index mark () is within the OK range after fitting the cuff on the upper arm.

If the measurement is performed on the right upper arm, the line should be located on the inside of your elbow. Ensure that your arm is not pressing on the line.
Blood pressure may vary between the right and left arm, which may mean that the measured blood pressure values are different. Always perform the measurement on the same arm.
If the values between the two arms are significantly different, please consult your doctor to determine which arm should be used for the measurement.

The instrument should only be operated with the original cuff. The cuff is suitable for an arm circumference of 22 to 30 cm. A larger cuff for upper arm circumferences from 30 to 42 cm is available from retailers or the service address under order no. 163.246.

Correct posture

• Before the initial blood pressure measurement, make sure always to rest for about 5 minutes. Otherwise there may be divergences.
• Furthermore, if you want to take several measurements in succession, make sure always to wait for at least 1 minute between the individual measurements.
• You can perform the measurement either sitting or lying down. Always make sure that the cuff is on a level with your heart.
• To carry out a blood pressure measurement, make sure you are sitting comfortably with your arms and back leaning on something. Do not cross your legs. Place your feet flat on the ground.
• In order not to distort the result, it is important to keep still during the measurement and not talk.

Measuring blood pressure

• Move the touch screen activation switch to the ON position.
• Put on the cuff as described previously and assume the position in which you want to carry out the measurement.
• Switch on the blood pressure monitor with the START/ STOP button . After the full-screen display, the most recently used user memory appears ( or ). To change the user memory, press the MEM button and confirm your selection with the START/STOP button . If no button is pressed, the most recently used user memory is automatically used after 5 seconds.
• Before the measurement, the last saved test result is briefly displayed. If there is no measurement in the memory, the instrument always displays the value .
• The cuff automatically inflates. Cuff air pressure is released slowly. If a tendency towards high blood pressure is already detectable, the cuff is pumped up again and cuff pressure increased further. As soon as a heart rate is detected, the heart rate symbol is displayed.
• Heart rate, systolic and diastolic blood pressure are displayed.
• You can cancel the measurement at any time by pressing the START/STOP button or by pushing the touch screen activation button to OFF.
• appears if it has not been possible to perform the measurement properly. Observe the section in these instructions on error messages/troubleshooting and repeat the measurement.
• The test result is saved automatically.
• To switch off the device, press the START/STOP button or push the touch screen activation switch to OFF. If you forget to switch off the device, it switches off automatically after approx. 1 minute.

Wait for at least 1 minute before taking another measurement.

Evaluating results

Cardiac arrhythmia:
This instrument can identify possible cardiac arrhythmia disorders during measurement and if necessary indicates the measurement with the flashing icon .
This may be an indicator for arrhythmia. Arrhythmia is a condition where the heart rhythm is abnormal as a result of defects in the bioelectrical system controlling the heart beat. The symptoms (omitted or premature heart beats, slow or excessively fast heart rate) may be caused, among other things, by heart disease, age, physical predisposition, excessive use of stimulants, stress or lack of sleep. Arrhythmia can only be ascertained through examination by your doctor.
Repeat the measurement if the flashing icon is displayed after the measurement. Please note that you should rest for 5 minutes between measurements and not talk or move during the measurement. If the icon appears often, please contact your doctor. Any self-diagnosis and treatment based on the test results may be dangerous. It is vital to follow your doctor's instructions.

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 unit 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.

Source: WHO, 1999 (World Health Organization)

Saving, retrieving and deleting results

• The results of each successful measurement are stored together with date and time. With more than 60 items of measured data, the earliest items of data measured are lost.
• Move the touch screen activation switch to the ON position.
• Make a selection with the MEM button, and then confirm the desired user memory with the START/STOP button . If you press the MEM button again, the average value of all the stored measured values in the user memory will be displayed. If you press the MEM button again, the average value of the last 7 days for the morning measurement will be displayed (Morning: 5 a.m. – 9 a.m., display ). If you press the MEM button again, the average value of the last 7 days for the evening measurement will be displayed (Evening: 6 p.m. – 8 p.m., display ). If you continue to press the MEM button, the most recent individual measured values with date and time are displayed in turn.
• You can delete the memory by pressing and holding the MEM button for 3 seconds. All the values in the current user memory are deleted after three beeps are output.
• To switch off the device, press the MEM button again or the START/STOP button or push the touch screen activation switch to OFF.
• If you forget to switch off the device, it will switch off automatically after 2 minutes.

Transferring measurements

Connect the blood pressure monitor to your PC using the USB cable.
No data transfer may be launched whilst performing a measurement.

PC 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 com munication with the PC is interrupted, the blood pressure monitor switches itself off automatically.

Error messages/trouble-shooting

In case of faults, the message appears in the display.
Error messages may appear if:

• systolic or diastolic pressure could not be measured
  ( or appears on the display)
• systolic or diastolic pressure was outside the measurement range ( or appears on the display)
• the cuff is fastened too tightly or loosely
  ( or appears on the display)
• the pump pressure is higher than 300 mmHg
  ( appears on the display)
• pumping up takes longer than 160 seconds
  ( appears on the display)
• there is a system or device error
  ( or appears on the display)
• the batteries are almost empty .

In the above cases, you must repeat the measurement.
Make sure that the cuff tube is properly inserted and that you do not move or talk.
Re-insert the batteries if necessary, or else replace them.

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.

Cleaning and storing the device and cuff

• 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.

Specifications

Model no.	BM 58
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 100 mm x W 150 mm x H 58 mm
Weight	Approx. 508 g (without batteries, with cuff)
Cuff size	22 to 30 cm
Permissible operating conditions	+5°C to +40°C, ≤ 90% relative air humidity (non-condensing)
Permissible storage conditions	-20°C to +55°C, ≤ 95% relative air humidity, 800 –1050 hPa ambient pressure
Power supply	4 x 1,5V AA batteries
Battery life	For approx. 500 measurements, depending on the blood pressure level and/or pump pressure
Classification	Internal supply, IPX0, no AP or APG, continuous operation, type BF applied 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.

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.

Replacement parts and wearing parts

Replacement parts and wearing parts are available from the corresponding listed service address under the stated material number.

Important information

Advice on use

• In order to ensure comparable values, always measure your blood pressure at the same time of day.
• Do not take a measurement within 30 minutes after eating, drinking, smoking or exercising.
• Before the initial blood pressure measurement, make sure always to rest for about 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.
• The measurements taken by you are for your information only – they are not a substitute for a medical examination! Discuss the measurements with your doctor, and never base any medical decisions on them (e.g. medicines and their administration)!
• 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.
• Do not use the blood pressure monitor on newborns or patients with preeclampsia. We recommend consulting a doctor before using the blood pressure monitor during pregnancy.
• Cardiovascular diseases may lead to incorrect measurements or have a detrimental effect on measurement accuracy. The same also applies to very low blood pressure, diabetes, circulatory disorders and arrhythmias as well as chills or shaking.
• This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who is responsible for their safety or are instructed by such a person in how to use the device. Supervise children around the device to ensure they do not play with it.
• The blood pressure monitor must not be used in connection with a high-frequency surgical unit.
• Only use the device on people who have the specified upper arm measurement for the device.
• Please note that when inflating, the functions of the limb in question may be impaired.
• During the blood pressure measurement, blood circulation must not be stopped for an unnecessarily long time. If the device malfunctions, remove the cuff from the arm.
• Avoid any mechanical restriction, compression or bending of the cuff line.
• Do not allow sustained pressure in the cuff or frequent measurements. The resulting restriction of the blood flow may cause injury.
• Ensure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or therapy, or an arteriovenous (AV) shunt.
• 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.
• You can either use the blood pressure monitor with batteries or with a mains part. Please note that data transfer and data storage is only possible when your blood pressure monitor is supplied with power. As soon as the batteries are empty or the mains part is disconnected from the power supply, the blood pressure monitor loses the date and time.
• To conserve the batteries, the monitor switches off automatically if no buttons are pressed for one minute.
• 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 careless use.

Storage and Care

• The blood pressure monitor is made up of precision electronic components. Accuracy of readings and the instrument's service life depend on careful handling.
  • You should protect the device from impact, moisture, dirt, major temperature fluctuations and direct exposure to the sun's rays.
  • Never drop the device.
  • Do not use near strong electromagnetic fields, i.e. keep it away from any radio systems and mobile phones.
  • Only ever use the cuffs provided with the monitor or original replacement cuffs. Otherwise erroneous results will be recorded.
• Do not press any buttons until the cuff is in position.
• If the instrument is not used for any length of time, we recommend removing the batteries.

Notes on 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. Store the batteries out of the reach of small children.
• Observe the plus (+) and minus (-) polarity signs.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
• Protect batteries from excessive heat.
• Risk of explosion! Never throw batteries into a fire.
• 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.
• Do not disassemble, split or crush the 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.