beurer BM 35 Upper Arm Blood Pressure Monitor Instruction Manual

beurer BM 35 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 one of our products. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, body temperature, pulse, gentle therapy, massage, beauty and air. Please 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.

Best regards,
Your Beurer Team

Included in delivery

• Blood pressure monitor
• Upper arm cuff
• 4 x 1.5 V LR03 AAA batteries
• Storage bag
• 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
indicates a hazardous situation which, if not avoided, could result in death or serious injury.
---|---
| CAUTION
indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.

| 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 cur- rent only
| Disposal
Disposal in accordance with EC Directive WEEE (Waste Electrical and Electronic Equip- ment)
| Battery disposal
Do not dispose of batteries containing hazard- ous 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.

| Item number
| Medical device (MDR Symbol)
| 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 me- dical device can safely be exposed.
| Atmospheric pressure, limit
Indicates the range of atmospheric pressures to which the medical device can be safely exposed

| IP class
Device protected against foreign objects ≥ 12.5 mm and against water dripping at an angle

| Serial number

| CE labelling
This product satisfies the requirements of the applicable European and national directives

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. The device is also ideal for taking blood pressure measurements on women who are pregnant. This was successfully tested as part of a clinical study (Tempestas, Institut für Medizinische Forschung, Cloppenburg, Germany).

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. This blood pressure monitor also has a haemodynamic stability display, which is referred to as a resting indicator throughout these instructions for use. This shows whether you, and consequently your circulatory system, are sufficiently at rest when the blood pressure measurement is being taken, and whether the measured blood pressure thus corresponds to your blood pressure when at rest. Read more about this under “Resting indicator” in the section on using the device.
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  he 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, 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 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.
• 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 tube
2. Cuff
3. Cuff connector
4. Cuff connector port (left side)
5. Memory button MEM
6. ON/OFF button
7. Display
8. Risk indicator
9. Function key
10. Adjustment button +

Display:

1. “Change battery” icon
2. Error icon _
3. Systolic pressure
4. Cardiac arrhythmia icon
5. mmHg unit
6. Icon for users ,
7. Diastolic pressure
8. Time and date
9. Number of memory space
10. Pulse icon
11. Measured pulse
12. Risk indicator
13. Memory display day/night (A,P: AM, PM)

Initial use

Inserting the batteries

• Remove the battery cover from the back of the monitor.
• Insert four AAA 1.5 V alkaline batteries. Making absolutely sure that you insert  them with the correct polarity as marked.
• 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.

Making 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:
• Press and hold the memory button on the device when for approx. 5 seconds.

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

Date

The month flashes on the display

• Using the + setting buttons, select your desired month and confirm with the memory button.

The day flashes on the display.

• Using the + setting buttons, select your desired day and confirm with the memory button.

If the hour format is set as 12h, the day/month display sequence is reversed.

The hour flashes on the display.

• Using the + setting buttons, select your desired number for the hour and confirm with the memory button.

The minute flashes on the display.

• Using the + setting buttons, select your desired number for the minute and confirm with the memory 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.

• Included in standard delivery

Attaching the cuff

• Pass your bare upper arm through the tube-shaped cuff. 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.

• 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.

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

• 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.

Select memory

Switch on the blood pressure monitor with the button. Select the required memory space by pressing the function key +. You have two memories (60 memory spaces each) in order to save the test results of 2 different people separately, or else save measurements in the morning and evening separately.

Performing the blood pressure measurement Measurement

• To start the blood pressure monitor, press the Start/stop button . All display elements are briefly displayed.
• Using the buttons +, select the user memory 1 or 2. Start the measurement process by pressing ON/OFF button . After checking the display with all digits lighting up, the monitor will automatically inflate.
• 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.

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

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 any cardiac rhythm 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 arrhythmia. Arrhythmia is an illness in which the heart rhythm is abnormal because of flaws in the bio electrical 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 disposition, excess alcohol and tobacco, stress or lack of sleep. If the symbol appears on the display after the measurement, the measurement must be repeated as the measurement accuracy may be impaired. To assess your blood 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 checkup, using their means of diagnosis.

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:

 | Measured blood pressure value range| Classification| Colour of the risk indicator
---|---|---|---
 | Systole (in mmHg)| Diastole (in mmHg)
 | ≥ 180| ≥ 110| High blood pressure stage 3 (severe)|

Red

160 – 179| 100 – 109| High blood pressure stage 2 (moderate)| Orange|
140 – 159| 90 – 99| High blood pres- sure stage 1 (mild)| Yellow|
130 – 139| 85 – 89| High normal| Green|
120 – 129| 80 – 84| Normal| Green|
< 120| < 80| Optimal| Green|

Source: WHO, 1999 (World Health Organization)

The risk indicator (the arrow in the display and the associated scale on the device) shows which category the recorded blood pressure falls 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 indifferent 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

Displaying and deleting measurements

User memory

• 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.
• Select the desired user memory by pressing the MEM button and then the + button.

Average values

• Press the MEM button again to display the average of all saved measurements in the user memory.
• If you press the MEM button again, the average value of the morning measurements for the last 7 days will be displayed (morning: 5.00 a.m. – 9.00 a.m., display A ).
• If you press the MEM button again, the average value of the evening measurements for the last 7 days will be displayed (evening: 5.00 p.m. – 9.00 p.m., display  ).

Deleting individual measurements

• If you continue pressing the MEM button, the latest individual results are displayed with date and time.
• To clear the memory, press the MEM button, then the display shows . Press the + button to select the user memory and confirm by pressing MEM again.
  Press and hold the + and keys simultaneously for 5 seconds (the display will show ).

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 thedevice 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.ies. The cuff tube should not have any sharp kinks

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?

and repeat the measu- rement, making sure to observe the information in chapter “Attaching the cuff”.

Please also check whe- ther the cuff line has been inserted properly and ensure that neither your arm nor other heavy objects are pressing on the line, and that the line is not bent.

E2| The inflation pres- sure is higher than 300 mmHg.| Please take another mea- surement to check whe- ther the cuff can be cor- rectly inflated.

Make sure that neither your arm nor other heavy objects are pressing on the line, and that the line is not bent.

| You moved or spoke during the measurement in addition to E3, the heart rhythm symbol is also shown on the dis- play .| Please wait one minute and repeat the measu- rement.

Ensure that you do not speak or move during the measurement.

| The blood pres- sure values are unusually high or low.|
| 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

the upper arm
Measurement range| Cuff pressure 0–300 mmHg, systolic 60–280 mmHg, diastolic 30–200 mmHg, Pulse 40–199 beats/minute
Display accuracy| Systolic ±3 mmHg, diastolic ±3 mmHg, pulse ±5% of the value shown
Measurement inaccuracy| Max. permissible standard deviation according to clinical testing: systolic 8 mmHg/diastolic 8 mmHg
Memory| 2x 60 memory spaces
Dimensions| L 135 mm x W 105 mm x H 53 mm
Weight| Approx. 327 g (without batteries)
Cuff size| 22 to 36 cm
Permissible operating conditions| +10°C to +40°C, 15-90% relative air humidity (non-condensing)
Permissible storage conditions| -25°C to +70°C, ≤ 93% relative air humidity, 860–1060 hPa ambient pressure
Power supply| 4x 1,5 V AAA 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, 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.

• 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 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 is in line with the EU Medical Devices Directive 93/42/EEC, the „Medizinproduktegesetz“ (German Medical Devices Act) and the standards EN 1060-3 (non-invasive sphygmomanometers, Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems)  andIEC 80601-2-30 (Medical electrical equipment – Part 2–30: Particular requirements for the safety and essential performance of automated non invasive blood pressure monitors).
• The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long useful life.
  If using the device for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address.

Warranty/service

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

References

• Beurer Gesundheitsratgeber
• Beurer Health Guide

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