beurer BM 40 Onpack Arm Blood Pressure Monitor Instruction Manual

: June 5, 2024
: Beurer

beurer BM 40 Onpack Arm Blood Pressure Monitor

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 acces-sories 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 1.5 V LR6 AA batteries
Mains part
Storage bag
Instructions for use

Important information

Signs and symbols
The following symbols are used on the device, in these instruc-tions for use, on the packaging and on the type plate for the device:

| 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 cur- rent only

| Disposal in accordance with the Waste Elec- trical and Electronic Equipment EC Directive

– WEEE

| 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 ele- ments and dispose of them in accordance with local regulations.
| Manufacturer
****| Permissible storage and transport tempera- ture and humidity
| Permissible operating temperature and hu- midity.
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| Protect from moisture
| Serial number
| Item number
| Medical device

| CE labelling

This product satisfies the requirements of the applicable European and national directives.

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 envi-ronment or whilst on the move (e.g. whilst travelling in a car, ambulance or helicopter, or whilst undertaking physical ac-tivity such as playing sport) can influence the measurement accuracy and cause incorrect measurements.
Do not use the blood pressure monitor on newborns or pa-tients with preeclampsia. We recommend consulting a doctor before using the blood pressure monitor during pregnancy.
Cardiovascular diseases may lead to incorrect measure-ments or have a detrimental effect on measurement ac-curacy. The same also applies to very low blood pressure, diabetes, circulatory disorders and arrhythmias as well as chills or shaking.
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 meas-urements. 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. intra-vascular access or therapy, or an arteriovenous (AV) shunt.
Do not use the cuff on people who have undergone a mas-tectomy.
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 automati-cally if no buttons are pressed for 3 minutes.
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 electron-ic 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 origi-nal replacement cuffs. Otherwise erroneous results will be recorded.
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, flush out 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 the 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 long period, take the bat-teries 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.

Repair and disposal

Batteries do not belong in domestic refuse. Used batteries should be disposed of at the collection points provided.
Never open the instrument. If these instructions are not heeded, the warranty will be null and void.
Never attempt to repair the instrument or adjust it yourself. We can no longer guarantee perfect functioning if you do.
Repairs may only be performed by Customer Service or authorized dealers. However, always check the batteries and replace them if necessary prior to making any complaint.
For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the unit at a suitable local collection or recycling point. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the lo-cal authorities responsible for waste disposal.

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 elec-tromagnetic 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 elec-tromagnetic immunity; this can result in faulty operation.
Failure to comply with the above can impair the performance of the device.

Unit description

Blood pressure monitor and cuff

beurer BM 40 Onpack Arm Blood Pressure Monitor 18

Cuff
Cuff tube
Cuff connector
Display
Connection for mains part
Memory button M
START/STOP button
SET button
Function buttons -/+-/+
Risk indicator
Connection for cuff connector (left-hand side)

Display:

beurer BM 40 Onpack Arm Blood Pressure Monitor 19

Date
Time
Inflate , release air
Systolic pressure
Memory display, average value
Unit in mmHg
Diastolic pressure
Battery replacement symbol
Pulse symbol
Memory space number
Cardiac arrhythmia symbol
Calculated pulse value / memory space number / memory display, average value (AL), morning (A), evening (P)
User memory
Risk indicator

Prepare measurement

Inserting battery

Remove the battery cover from the back of the monitor.
Insert four AA 1.5 V alkaline batteries. Making absolutely sure that you insert them with the correct polarity as marked. Never use rechargeable bat teries.
Replace the battery cover carefully.

If 4 warning tones have been sounded and the symbol appears simultaneously on the display, it is no longer possible to perform a measurement and all batteries must be replaced. Once the batteries have been removed from the device, the date and time must be set again. Any saved measurements are retained.

Battery disposal

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

Setting the user memory, date and time
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 to retrieve them later.
The time is displayed in the 24-hour format.

If you press and hold the function buttons -/+-/+, you can set the values more quickly.

User memory

Press the SET button. The user memory symbol flashes on the display.
Select the desired user memory by pressing the function buttons -/+-/+.
You have two memories, each with 60 memory spaces, to store the measurements of two different people separately.
Confirm using the SET button.

Date/time

The year flashes on the display.

Set the year with the function buttons -/+-/+ and con-firm with the SET button.
Set the month, day, hour and minute and confirm each setting with the SET button.

When making settings, you can use the START/STOP button at any time to switch the device off. The set-tings that have already been performed will be retained.

Operation with the mains part
You can also operate this device with a mains part. 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 prevent possible damage to the device, the blood pres-sure monitor must only be used with the mains part de-scribed here.
Furthermore, the mains part must only be connected to the mains voltage that is specified on the type plate.
Insert the mains part into the connection provided for this purpose on the right-hand side of the blood pressure moni-tor.
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.

Measuring blood pressure

Please ensure the device is at room temperature before meas-uring. The measurement can be performed on the left or right arm.

Positioning cuff

Fit the cuff round your bare upper arm. Blood circulation in the arm should not be restricted by tight clothing or other objects.
The cuff should be placed on the upper arm so that the lower edge is 2 to 3 cm above the bend of the elbow and above the artery. The tube should be in line with the centre of the palm.
Now place the free end of the cuff snugly, but not too tightly, around the arm, and fix it with the Velcro fastener. The cuff should be fitted tight enough to allow just two fingers to fit beneath the cuff.
Insert the cuff tubing into the socket for the cuff attachment.
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. En-sure 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 differ-ent. 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
Important: The instrument should only be operated with the original cuff. The cuff is suitable for an arm circumference of 22 to 35 cm. A larger cuff for upper arm circumferences from 30 to 42 cm is available from retailers or the service address under order no. 162.973.

Adopting the correct posture

beurer BM 40 Onpack Arm Blood Pressure Monitor 28

Rest for approx. 5 minutes before each measurement. Other-wise there may be divergences.
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.

Performing the blood pressure measurement

Measurement

As described above, attach the cuff and adopt the posture in which you want to perform the measurement.
Start the device with the START/STOP button . Following the display check, during which all numbers light up, the cuff inflates automatically.
The cuff is inflated to 190 mmHg. 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 detected, the pulse symbol flashes.
Measuring can be cancelled at any time by pressing the START/STOP button .
Systolic pressure, diastolic pressure and pulse readings are displayed.
appears if the measurement has not been per-formed properly. Observe the chapter on error mes-sages/trouble-shooting in these instructions for use and repeat the measurement.
The measurement is automatically stored.
The device switches off automatically after 3 minutes.

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 condi-tion 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 exces-sively 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 dur-ing 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 accord-ance with the following table. However, these standard values serve only as a general guide-line, 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 pres-sure as well as the value above which your blood pressure is classified as dangerous. The bar graph in the display and the scale on the unit indicate the range of the blood pressure which has been recorded. If the values for systolic and diastolic pressure are in two differ- ent ranges (e.g. systolic in the high-normal range and diastolic pressure in the normal range) the graphic classification on the unit indicates the higher range (high-normal in the example described).

Blood pressure value category| Systole

(in mmHg)

| Diastole

(in mmHg)

| Action
---|---|---|---
Setting 3: severe hypertension|

≥ 180

|

≥ 110

| seek medical at- tention
Setting 2: moderate hypertension|

160 – 179

|

100 – 109

| seek medical at- tention
Setting 1: mild hypertension|

140 – 159

|

90 – 99

| regular monitoring by doctor
High normal| 130 – 139| 85 – 89| regular monitoring by doctor
Normal| 120 – 129| 80 – 84| self-monitoring
Optimal| < 120| < 80| self-monitoring

Saving, displaying 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.

the SET button and the function buttons -/+-/+. Confirm your selection with the START/STOP button .

Average values

Press the memory button M. The average value of all saved measured values in this user memory is dis-played first AL.
If you press the memory button M again, the average value of the morning measurements for the last 7 days will be displayed (morning: 5.00 a.m. – 8.59 a.m., dis-play A ).
If you press the memory button M again, the average value of the evening measurements for the last 7 days will be displayed (evening: 6.00 p.m. – 7.59 p.m., dis-play P ).

I f there is no measurement in the memory, the de-vice displays.

Individual measured

• If you press the function buttons -/+-/+, the most recent individual measured values are displayed in turn with the date and time. By pressing the function button
++ the most recent measurements are displayed; by pressing the function button –, the oldest are dis-played.

Deleting measured values

To clear the memory of the relevant user memory, you must first select a user memory. Start a request for ei-ther average values or individual measured values and press and hold the SET button for approx. 3 seconds. All the values in the current user memory are deleted after 3 brief beeps are output.
You have the option to delete individual measured val-ues by pressing the SET button when the measured values are displayed after the measurement.
To switch off, press the START/STOP button .
If you forget to switch off the device, it will switch off automatically after 3 minutes.

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 wa-ter, 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.

Error messages / troubleshooting

In case of faults, the message appears in the display. Error messages can occur when

Systolic pressure is not detected,
Diastolic pressure is not detected,
The cuff is fastened too tightly or loosely,
The pump pressure is higher than 300 mmHg,
There is a system or unit error.

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.

Specifications

Model no: BM 40
Measurement: Oscillometric, non-invasive blood pressure measurement on the upper arm
Measurement range: Cuff pressure 0 – 300 mmHg, systolic 60 – 280 mmHg, diastolic 30 – 200 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 119 mm x W 109 mm x H 60 mm
Weight: Approx. 387 g (without batteries, with cuff)
Cuff size: 22 to 35 cm
Permissible operating conditions: + 10 °C to + 40 °C, 20-90% relative air humid-ity (non-condensing)
Permissible storage conditions: – 25 °C to + 55 °C, 20-90 % relative air humid-ity, 700 –1060 hPa ambient pressure
Power supply: 4 x 1,5 V
Battery life: For approx. 250 measurements, depending on the blood pressure level and/or pump pressure
Classification: Internal supply, continuous operation, type BF applied part, IP20, no AP or APG

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, IEC61000-3-2, IEC61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8, IEC61000-4-11) 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 1060-1 (non-invasive sphygmomanometers, Part 1: General requirements), EN 1060-3 (non-invasive sphygmomanometers, Part 3: Sup-plementary requirements for electro-mechanical blood pres-sure measuring systems) and IEC 80601-2-30 (Medical elec-trical 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 care-fully 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.

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 pro-tected against short circuit and overload by a primary thermal fuse. Make sure to take the batteries out of the compartment before using the mains part.
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 part simul-taneously.