Beurer BM35 BM 35 Upper arm blood pressure monitor

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User Manual

This is the main product document for model BM35.

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Beurer GmbH
Söflinger Straße 218, 89077 Ulm, Germany
www.beurer.com
www.beurer-healthguide.com
BM 35
Upper arm blood pressure monitor
ENGLISH
Repairs may only be performed by Customer Service or authorized
dealers. However, always check the batteries and replace them if nec-
essary 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
local 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 electromag-
netic 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 work-
ing 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.
3. Device description
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 +
Information on the 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)
4. Prepare measurement
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.
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.
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 date, time and language
It is vital to set the date and time. This is the only way that measure-
ments can be saved and recalled with the correct date and time. The
time is shown in 24 hour format.
Proceed as follows to set the date and time:
Switch on the blood pressure monitor with the button.
Press the function .
The month starts flashing. Using the + function key, set the month 1 to
12 and confirm with the function key .
Set the day, hour and minute and confirm in each case with the func-
tion key .
Confirm your selection with the function key .
5. 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 per-
form 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 36 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
Before the initial blood pressure measurement, make sure always to
rest for about 5 minutes. Otherwise 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.
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
Put on the cuff as described previously and assume the position in
which you want to carry out the measurement.
Using the buttons +, select the user memory 1 or 2. Start the meas-
urement process by pressing ON/OFF button . After checking
the display with all digits lighting up, the monitor will automatically
inflate. Following the self-test, during which all display elements briefly
appear, the measurement begins. During inflation the device already
determines measured values used to estimate the required infla-
tion pressure. If this pressure is insufficient, the device automatically
inflates by another.
Then the pressure in the cuff is slowly released and the pulse is meas-
ured.
When the measurement has been completed, the remaining air pres-
sure is released very quickly. The pulse, the systolic and the diastolic
blood pressure are displayed.
1 32
4
5
8
6
9
10
7
2
6
13
10
8
1
4
11
9
3
7
12
5
4 x AAA (LR03) 1,5
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.
Included in delivery
Blood pressure monitor
Upper arm cuff
4 x 1.5 V LR03 AAA batteries
Instructions for use
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
1. 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 vis-
ible 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 meas-
urement 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. Keep these
instructions carefully for further use and also let other users have access
to them.
2. Important information
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 EC Directive WEEE (Waste
Electrical and Electronic Equipment).
21
PAP
Dispose of packaging in an environmentally friendly
manner
Manufacturer
Storage/Transport
Permissible storage and transport temperature and
humidity
Operating
Permissible operating temperature and humidity
Protect from moisture
S
N
Serial number
CE labelling
This product satisfies the requirements of the applica-
ble European and national directives.
Notes 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 med-
ical decisions on them (e.g. medicines and their administration)!
Do not use the blood pressure monitor on newborns, pregnant women
or patients with preeclampsia.
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 has responsibility for their safety or they receive instructions from
this person on how to use the device. Supervise children around the
device to ensure they do not play with it.
Using the blood pressure monitor outside your home environment or
whilst on the move (e.g. whilst travelling in a car, ambulance or heli-
copter, or whilst undertaking physical activity such as playing sport)
can influence the measurement accuracy and cause incorrect meas-
urements.
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.
The blood pressure monitor can be operated with batteries. Please
note that data transfer and data storage is only possible when your
blood pressure monitor is supplied with power. As soon as the batter-
ies are empty, 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 instruc-
tions for use. The manufacturer is not liable for damage resulting from
improper or careless use.
Instructions for storage and maintenance
The blood pressure monitor is made up of precision electronic compo-
nents. 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 replace-
ment 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 bat-
teries. 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 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.
Instructions for repairs 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.
background
The buyer will then receive further information about the processing of
the warranty claim, e.g. where they can send the product and what doc-
umentation is required.
A warranty claim shall only be considered if the buyer can provide Beur-
er, or an authorised Beurer partner, with
- a copy of the invoice/purchase receipt, and
- the original product.
The following are explicitly excluded from this warranty:
- deterioration due to normal use or consumption of the product;
- accessories supplied with this product which are worn out or used up
through proper use (e.g. batteries, rechargeable batteries, cuffs, seals,
electrodes, light sources, attachments and nebuliser accessories);
- products that are used, cleaned, stored or maintained improperly and/
or contrary to the provisions of the instructions for use, as well as prod-
ucts that have been opened, repaired or modified by the buyer or by a
service centre not authorised by Beurer;
- damage that arises during transport between manufacturer and cus-
tomer, or between service centre and customer;
- products purchased as seconds or as used goods;
- consequential damage arising from a fault in this product (however, in
this case, claims may exist arising from product liability or other com-
pulsory statutory liability provisions).
Repairs or an exchange in full do not extend the warranty period under
any circumstances.
Beurer India Private Limited
Unit-2, No. 43, Red hills road
Kadapakkam Village, Andarkuppam
Manali new town
Chennai -Tamilnadu 600103
India
+91 124 4477111
You can interrupt measurement at any time by pressing the ON/OFF
button .
The _ icon appears if it has not been possible to perform the meas-
urement properly. Observe the section in these instructions on error
messages/troubleshooting and repeat the measurement.
The device switches off automatically after 1 minute.
Wait for at least 1 minute before taking another measurement.
6. Evaluating results
Cardiac arrhythmia:
This instrument can identify possible cardiac arrhythmia disorders dur-
ing 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 ascer-
tained 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 cate-
gory 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 cate-
gory; for the example given this would be High normal.
Blood pressure
value category
Systole
(in mmHg)
Diastole
(in mmHg)
Action
Setting 3: severe
hypertension
red ≥ 180 ≥ 110 seek medical
attention
Setting 2: moderate
hypertension
orange 160 – 179 100 – 109 seek medical
attention
Setting 1:
mild hypertension
yellow 140 – 159 90 – 99 regular monito-
ring by doctor
High normal green 130 – 139 85 – 89 regular monito-
ring by doctor
Normal green 120 – 129 80 – 84 self-monitoring
Optimal green < 120 < 80 self-monitoring
Source: WHO, 1999 (World Health Organization)
7. 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.
Select the desired user memory by pressing the MEM button and then
the + button.
Press the MEM button again to display the average of all saved meas-
urements 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
).
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
).
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 simultane-
ously for 5 seconds (the display will show ).
If you wish to change the user memory, see “Select memory”.
8. 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.ies. The cuff tube should not have any sharp kinks
9. Error messages/troubleshooting
I
n case of faults, the _ message appears in the display.
E
rror messages can occur when
1. inflation pressure is higher than 300 mmHg,
2. blood pressure is unusually high or low ,
3. you move or talk during the measurement (in addition to , the car-
diac arrhythmia icon appears in the display ),
4. the cuff tube is not inserted properly ,
5. the cuff is inflated for longer than 25 seconds .
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.
10. Technical Specifications
Type: BM 35/1
Model no. BM 35
Measurement method 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 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 2 x 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
+ 50 °F to + 104 °F (+ 10 °C to + 40 °C),
15-90 % relative air humidity (non-condensing)
Permissible storage
conditions
- 13 °F to + 158 °F (- 25 °C to + 70 °C),
≤ 93 % relative air humidity,
860 –1060 hPa ambient pressure
Power supply
4 x 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 compart-
ment.
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) and IEC80601-2-30 (Medical electrical equip-
ment – 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.
11. Replacement parts and wearing parts
Replacement parts and wearing parts are available from the correspond-
ing listed service address under the stated material number.
Designation Item number and/or order number
Standard cuff (22-36 cm) 163.537
XL cuff (30-42 cm) 162.973
12. Warranty / service
Beurer India Private Limited
Unit -2, No. 43, Red hills road
Kadapakkam Village, Andarkuppam
Manali new town
Chennai -Tamilnadu 600103
India
(hereinafter referred to as “Beurer”) provides a warranty for this product,
subject to the requirements below and to the extent described as follows.
The warranty conditions below shall not affect the seller’s statutory
warranty obligations which ensue from the sales agreement with
the buyer.
The warranty shall apply without prejudice to any mandatory statu-
tory provisions on liability.
Beurer guarantees the perfect functionality and completeness of this
product.
The worldwide warranty period is 5 years, commencing from the pur-
chase of the new, unused product from the seller.
The warranty only applies to products purchased by the buyer as a
consumer and used exclusively for personal purposes in the context of
domestic use.
German law shall apply.
During the warranty period, should this product prove to be incomplete
or defective in functionality in accordance with the following provisions,
Beurer shall carry out a repair or a replacement delivery free of charge, in
accordance with these warranty conditions.
If the buyer wishes to make a warranty claim, they should approach
their local retailer in the first instance.
BM35_2020-07-15_01_IM_BEU-IN-LE
Subject to errors and changes

Specifications

Beurer BM35 Questions and Answers

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