SBM 52 E Instructions for use

Arm blood pressure monitor with voice

0483 Service Hotline: E Tel.: 912 754 663

 E SPANISH
Carefully read these instructions for use, keep them for future use, ensure they are
accessible to other users and follow the instructions.
1. Introduction
The arm sphygmomanometer is used for measuring and controlling arterial blood pressure values.
in a non-invasive manner in adults.
With it, blood pressure can be measured quickly and easily, and the values of the measurement can be stored.
in the memory and check the evolution and average of the measured values. It also warns of even-
current alterations of heart rhythm.
The measured values are classified and evaluated graphically according to the WHO guidelines.
Keep these instructions for use so you can continue to use them and make sure they are available.
available for other users.
2. Important indications
Instructions for use
• Always take your blood pressure at the same time of day to ensure that the values are comparable.
• Rest for about 5 minutes before each measurement.
• Wait about 5 minutes between measurements.
• The measurements performed by you are for informational purposes only and cannot, in any case, replace
to undergo a medical examination. Consult the values you obtain with your doctor. Under no circumstances should you
make medical decisions on your own (e.g. about medications and their dosage).
• Measurement errors can occur due to cardiovascular diseases, as well as in case
having very low blood pressure, circulatory problems, heart rhythm disturbances, or
having suffered from previous pathologies.
• Only people with the indicated arm diameter for the device can use it.
• You can use the battery-operated tonometer or connect it to the power supply for the network. Note that the
Data storage is only possible if your tonometer receives power. As soon as I do so-
If the batteries or power supply are disconnected from the network, the tonometer will lose the date and time.
• The automatic disconnection turns off the blood pressure monitor to save the batteries if no key is pressed.
during a one-minute interval.
Conservation and care instructions
• The measuring device is composed of electronic and precision elements. Both the accuracy of
The measurement values such as the lifespan of the device depend on its correct use:
Protect the device from impacts, humidity, dirt, large thermal fluctuations, and exposure to...
straight to sunlight.
Avoid letting the device fall.
Do not use the device near high-intensity electromagnetic fields and keep
rooster away from radio and mobile phone installations.
Only replacement bracelets or the original bracelets that come with the device can be used.
Otherwise, incorrect measurement values will be obtained.
• Do not press any key if you do not have the bracelet on.
• If the device is not going to be used for an extended period of time, it is recommended to remove the batteries.
Instructions about batteries
• Batteries can be deadly if ingested. Therefore, batteries and products should be stored.
Keep out of reach of young children. In case of swallowing a battery, seek medical attention immediately.

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• Batteries cannot be charged or reactivated by other means, they cannot be dismantled, thrown into the fire.
do not short-circuit yourself.
• Remove the batteries from the device when they are depleted or if it will not be used for a period of
prolonged time. This way, damage that could occur due to leaks is avoided.
drain all the batteries at once.
• Do not use different types or brands of batteries, nor batteries of different capacities. Preferably use
alkaline batteries.

Instructions regarding repairs and waste disposal

• Do not dispose of batteries with household waste. Take used batteries to the designated collection points.
tos for such purpose.
• Do not open the device. Failure to comply with this rule voids the warranty.
• Do not repair or adjust the device yourself. If you do, proper functioning is not guaranteed.
• Repairs should only be left to customer service or authorized dealers.
Before making any claim, check the battery status and replace them if necessary.
• Dispose of the device according to European Directive 2002/96/EC on waste electrical and electronic equipment
and electronics (WEEE = Waste Electrical and Electronic Equipment). For more information, please contact
get in touch with the competent municipal authority regarding waste removal.
3. Description of the device
2 Instructions on the screen:
3
11 1
1 8
7 10 2
9
6 3

4
10 9 5
5
4 6

8 7
Bracelet Inflate Deflate
2. Flexible arm cuff tube 2. Systolic pressure
3. Bracelet connector 3. Memory indications:
4.Start/Stop button average value ( ), tomorrow ( ),
5. Function keys afternoon ),
6. WHO classification by LED 4. Diastolic pressure
7. Connection for the bracelet connector 5. User memory
8. Screen 6. Measured pulse
9. Connection for the network adapter (right side) 7. Symbol of rhythm alteration
10.Memory key cardiac
8. Time and date
9. WHO Classification
10. Space number in memory
11. Battery replacement symbol

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4. Preparation of the measurement
Battery placement 4 x AA (LR6) 1.5 V
• Open the battery compartment cover.
• Place four batteries of type 1.5V AA (alkaline type LR6). Check.
that the batteries have been installed according to the indicated correct polarity.
Do not use rechargeable batteries. The indication "The device is ready."
appears.
• Carefully close the battery compartment cover again.
• Once the batteries are inserted, the device permanently displays the time and date.
When the battery change symbol appears y no action can be taken
Measurement. The device indicates: "Weak battery". Replace all batteries. As soon as the batteries are removed from the
device, the time, date, and language must be readjusted.
Do not dispose of used batteries with household waste. Dispose of them through your distributor.
of electronic products or at its recyclable waste collection point. It is obligated
by law.
Indication: these symbols are found on batteries containing toxic substances:
the battery contains lead
Set date, time, and language
From this menu you can adjust the functions mentioned below:
Date Hour Language Volume
First of all, you need to set the date and time of the device, as only then can the data be stored.
your measurements with the correct date and time for later consultation.
The time is displayed in 24-hour format.
The device can be configured in 3 languages. In the supply state, the device is set to
to function in German.
If you hold down the function keys you will be able to adjust the values more quickly.

Voice function
• Turn on the device with the START/STOP button . The device is ready.
• Press and hold the memory key for 5 seconds-
two.
The year indicator blinks on the screen.
• Adjust the year with the function keys and confirm it with the
memory key .
• Adjust the month, day, hour, and minute, and confirm each one.
they with the memorization key .
The language indicator blinks on screen.
• With the function keys you can choose from the following
languages:
German German
English English
Spanish Spanish
Disable voice
Confirm the selection with the memory key .
Disabling voice means that there is no language selected.
switched off and therefore, there is no acoustic indication.

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 Voice function
The volume indicator Vo3 blinks on the screen.
• With the function keys you can adjust the language volume
selected
Vo3 = high
Vo2 = average
Vo1= low
Confirm the selection with the memorization key .

Operation with the power supply

You can also use this device with a power supply. To do so, there should be no batteries in the device.
compartment for batteries. The power supply is available in specialized stores.
ados or in the technical assistance service with the order number 071.30.
• The tensiometer should be used exclusively with the power supply described here, to avoid
possible damage to the manometer.
Connect the power supply to the designated connection on the right side of the tension unit.
The power supply can only be connected to the mains voltage indicated on the label.
type indicator.
Next, connect the power supply plug to the wall outlet.
After using the sphygmomanometer, first disconnect the power supply from the outlet.
and below the manometer. As soon as I disconnect the power supply, the manometer per-
the date and time will be given. However, the stored measurement values are retained.
5. Measurement of blood pressure
Make sure the device is at room temperature before taking the measurement.
Placement of the bracelet
Put on the bracelet The bracelet must colo- Adjust the free end Insert the tube
on the left arm, to throw oneself on the arm of for- around the bracelet flexible of the bracelet in
that must be un- but what about the lower edge from the arm without leaving the connection for the co-
covered. The circulation I stayed between 2–3 cm due to being too tense and blind. bracelet connector.
blood vessel in the arm on top of the joint He takes off the Velcro. The bracelet
should not be restricted elbow flexion and on the it must remain the suffi-
give for clothes or for something artery. The flexible tube recently adjusted
similar. must point towards the so that they fit
half of the palm of the two fingers below the
hand. same.

Attention: the device should only be used with the original cuff. The cuff is designed for a
arm diameter between 22 and 36 cm.

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Adoption of a correct posture
• Rest for about 5 minutes before each month.
Otherwise, issues could arise.
variations.
• You can sit or lie down to perform the
measurement. Always make sure that the arm-
the diaphragm is located at the level of the heart.
• To avoid falsifying the measurement result, it is important not to move or speak during it.
Record selection
Language with voice function
activated
• Turn on the device with the START/STOP button . The device is ready.
When the device is off, the time and date remain
visible.
• Select the user record by pressing the function key .
User 1 memory
User memory 2
Memory of user 3
User memory 4
It has 4 shelves with 30 storage slots each.
one to store the measurement results separately
of 4 different people.

Blood pressure measurement

Language with voice function
activated
• Put on the bracelet as described above and place it...
take the position in which you wish to make the measurement.
• Turn on the device with the START/STOP button . The device is ready.
• The screen is checked by lighting up all the
segments of the screen.
• Turn on the device with the START/STOP button It appears
the storage position that is going to be occupied.
• The cuff inflates to 180 mmHg. The air pressure of the cuff
decreases slowly. When a trend is detected towards the
high tension, air is pumped again and increases again the
bracelet pressure. As soon as the pulse is detected, it blinks the
symbol .
The measurement process can be interrupted at any time.
mente pressing the START/STOP key .

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 Language with voice function
activated
• The results of the systolic blood pressure measurements appear, Systolic ... mmHg
of diastolic pressure and of the pulse. Diastolic ... mmHg
Heart rate ... beats
per minute
According to the WHO guidelines
optimal
normal
high normal
high rise
moderate high
high fever
You can change the volume with the function keys during
the message.
• appears when the measurement could not be performed correctly
mind. Please refer to the Error Notice/Troubleshooting section.
more of these instructions for use and repeat the measurement.
• The measurement result is stored in the automatic memory.
mind.
• The device automatically turns off after a minute.
Wait at least 5 minutes to take a new measurement!

6. Evaluation of the results

Heart rhythm disturbances
This device is capable of recognizing potential alterations in heart rhythm during measurement, and in
in case this happens, it is indicated after the measurement with the symbol If the voice function is activated,
The device emits the message: "A possible heart rhythm disorder has been diagnosed." This alters
conditions can be an indicator of arrhythmia. Arrhythmia is a disease in which the heart rhythm is
abnormal due to the presence of damage in the bioelectric system that controls the heartbeat.
Their symptoms (palpitations, slower or too fast pulse) may be caused by illness
cardiac data, age, physical predisposition, excess stimulants, stress or lack of sleep,
among other causes. Arrhythmia can only be diagnosed with a medical examination. Repeat the measurement if,
after performing it, the symbol appears on the screen Please note that you should let it rest for 5 minutes.
coughs and that during the measurement one cannot talk or move. If the symbol appears frequently, with-
Consult your doctor. Performing a self-diagnosis and starting treatment on your own can be dangerous.
It is essential to follow a doctor's instructions.

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WHO classification
According to the guidelines and/or definitions of the World Health Organization (WHO), the results-
Two of the measurements are classified and evaluated according to the following table:

Range of the values of the Systole Diastole Solution

blood pressure (in mmHg) (in mmHg)
Level 3: elevated hypertension g r e a t e r t h a n o r e q u>a=l11
t o0 1 8 0 Seek medical attention
Level 2: moderate hypertension 160–179 100–109 Seek medical attention
Level 1: mild hypertension 140–159 90–99 Submit to medical check-ups with
regularity
High normal 130–139 85–89 Undergo medical examinations with
regularity
Normal 120–129 80–84 Follow up on your own
Optimal <120 <80 Follow up on your own
Source: WHO, 1999

The bar graph on the screen and the scale on the device indicate the range in which the pressure is.
blood measurement.
If the systolic and diastolic values are in two different ranges of the WHO (e.g., systolic
in the high normal blood pressure range and diastole in the normal range), the WHO classification chart
The device always indicates the highest range. In this example, it shows 'High Normal'.
7. Storage, querying and deletion of measured values
You can change the volume with the function keys during the message.
Language with voice function
activated
The results of all correctly conducted measurements
They are stored in memory along with the date and time. When there is
more than 30 measurement values, the oldest measurement data
they get lost.
• Turn on the device with the START/STOP button . The device is ready.
• Choose the user record you want pressing the …
key Memory of user 1
of function . User memory 2
User memory 3
User memory 4
• Press the memory button. First, the Average value:
average value of all recorded measurements of this register Systolic ... mmHg
user's tro .
• Pressing the memory key again, it shows the Diastolic ... mmHg
average of the morning measurements taken in the last 7 Heart rate ... beats
days (tomorrow: from 5:00 to 9:00 hours, indicator ). per minute
• Pressing the memory key again, the me- According to the guidelines of the
afternoon measurement day conducted in the last 7 days OMS ...
(afternoon: from 6:00 PM to 8:00 PM, indicator ).

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 Language with voice function
activated
• Pressing the memory key again, each value of Memory space ...
individual measurement will be shown with its corresponding date and Systole ... mmHg
hour.
Diastole ... mmHg
Heart rate ... beats
per minute
According to the guidelines of the
OMS ...

• To delete the values of each user record, turn on the

sphygmomanometer, select the user record and, after pressing the key
for memorization, hold down the keys at the same time All the values of the
function and for five seconds. memory has been erased.
• To turn off, press the START/STOP button .
• If you forget to turn off the device, it will turn off automatically.
A minute has passed.

8. Error Notice/Troubleshooting
In case of error, the error message _ appears on the screen.
Failure alerts are displayed when
when the pulse cannot be registered ),
2. The patient moves or speaks during the measurement (the heart rhythm symbol appears on the screen) al
side of ),
3 the inflation takes more than 25 seconds ),
4 . when errors occur during measurement ( ),
5 . the inflation pressure exceeds 300 mmHg ( ),
6 The batteries are practically exhausted. ( ).
In these cases, repeat the measurement. Try not to move or talk during it.
If necessary, replace or change the batteries.
9. Cleaning and storage of the device
• Carefully clean the sphygmomanometer only with a slightly damp cloth.
• Do not use cleaners or solvents.
• The device should not be submerged under any circumstances, as liquid may penetrate it and damage it.
• When the device is stored, heavy objects should not be placed on it. Remove the
batteries. The flexible tube of the bracelet should not bend at very sharp angles.
10. Technical Data
Model number SBM 52
Measurement method Oscillometric, non-invasive measurement of blood pressure in the arm
Measurement range Pressure 0–300 mmHg, systolic 50–250 mmHg, diastolic 30–200 mmHg,
pulse 30–180 beats/minute
Precision Systolic 3 mmHg/diastolic 3 mmHg/pulse 5% of the indicated value
Inaccuracy of measurement The maximum allowed standard deviation according to clinical trial is:
systolic 8 mmHg/diastolic 8 mmHg

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Memory 4 x 30 storage spaces
Measurements 134 mm (largo) x 102 mm (ancho) x 53 mm (alto)
Weight approximately 287 g
Bracelet diameter From 22 to 36 cm
Operating temperature
permitted +10°C to +40°C
Storage temperature
allowed lie -5°C to +50°C, 10–85% relative humidity
Food 4 x 1.5V AA batteries (alkaline type LR6)
Battery lifespan For about 250 measurements, according to the high blood pressure and the
inflation pressure
Accessories Bag, instructions for use, 4 batteries of 1.5VAA
Protection class Internal power supply, IPX0, without AP or APG category, operation
continuing
Explanation of the symbols Type B application piece
Attention!
Read the instructions for use.
Manufacturer
Reserved the right to make modifications to the technical data without prior notice for reasons of
update.
• This device complies with European standard EN60601-1-2 and is subject to special measures of
precautions regarding electromagnetic compatibility. Please note that the devices
High-frequency communication devices and mobiles can interfere with this device. You can request
more accurate information to the customer service at the address indicated in this document or
read the end of the instructions for use.
• This device complies with the European directive regarding medical devices 93/42/EEC, the laws
related to medical products and the European standards EN1060-1 (Non-invasive sphygmomanometers,
Part 1: General requirements) and EN1060-3 (Non-invasive sphygmomanometers, Part 3: Supplementary requirements
applicable comments on electromechanical systems for measuring blood pressure.
Power supply
Model number FW7333SM/06
Input 100–240V, 50–60 Hz
Exit 6V DC, 1150 mA only in combination with Sanitas pressure gauges
Manufacturer Friwo Device Manufacturing Ltd.

Protection The device is equipped with double insulation for protection and a
fusible on its main side, which disconnects the device from the network
breakdown case.
During the intended use of the device, the green LED lights up.
Make sure you have removed the batteries from the battery compartment.
before using the adapter.
Protection isolation/Protection class 2

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Case and protective cover The adapter housing acts as protection against the parts.
subjected, or what can be seen as subjected, to the current (finger, needles,
safety hook.
The user should not touch either the patient or the outlet immediately.
from the AC adapter.
• The power supply FW7333SM/06 complies with the IEC 60601-1:2005 standard. In addition,
All configurations comply with the standards for electrical medical systems (see
IEC 60601-1-1 and § 16 of the third edition of IEC 60601-1). You can request more information.
contact customer service at the address indicated in this document.
11. Warranty/Customer Service
We offer a 3-year warranty from the date of purchase for manufacturing defects and material defects.
product.
The warranty is not valid:
• In case of damages resulting from inappropriate use.
• For wear parts.
• Due to issues that were already communicated to the client at the time of purchase.
• Due to client errors.
This warranty does not alter the customer's legal warranties. To approve the application of the warranty within
of its term, the customer must prove the purchase of the product. The warranty is valid within a period of
3 years from the date of purchase
Hans Dinslage GmbH
Riedlinger Str. 28
88524 Uttenweiler, Germany.
The customer has the right to repair the merchandise at our offices under the warranty application.
own or authorized by us. Do not open the device for any reason; if opened or modified
the right of guarantee is annulled.
No other rights are granted to the customer (due to the warranty).
In most cases, the reason for the complaints is a handling error that can be resolved.
easily by phone. Contact the technical support line by calling
the
E Tel.: 912 754 663

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Electromagnetic Compatibility Information
Guidance and manufacturer's declaration – electromagnetic emissions – for all EQUIPMENT and SYSTEMS
Guidance and manufacturer's declaration – electromagnetic emission
The SBM52 blood pressure monitor is intended for use in the electromagnetic environment specified below. The custo-
The user of the SBM52 blood pressure monitor should ensure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions CISPR11 Group 1 The SBM52 blood pressure monitor uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interference.
rence in nearby electronic equipment.
RF emission CISPR11 Class B The SBM52 blood pressure monitor is suitable for use in all establishments, inclu-
ding domestic establishments and those directly connected to the public low-vol-
secondary power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer's declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS
Guidance and manufacturer's declaration – electromagnetic immunity
The SBM52 blood pressure monitor is intended for use in the electromagnetic environment specified below. The custo-
the user of the SBM52 blood pressure monitor should ensure that it is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic environment – guidance
test level level
Floors should be wood, concrete, or ceramic tile. If floor
Electrostatic discharge (ESD) 6 kV contact 6 kV contact
are covered with synthetic material, the relative humi-
IEC 61000-4-2 8 kV air 8 kV air
dity should be at least 30%.
Power frequency (50Hz) Power frequency magnetic fields should be at levels
magnetic field 3A/m 3A/m characteristic of a typical location in a typical commercial
IEC 61000-4-8 cial or hospital environment.

Guidance and manufacturer's declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING
Guidance and manufacturer's declaration – electromagnetic immunity
The SBM52 blood pressure monitor is intended for use in the electromagnetic environment specified below. The custo-
The user of the SBM52 blood pressure monitor should ensure that it is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic environment – guidance
test level level
Portable and mobile RF communications equipment should be used no clo-
be any part of the SBM52 blood pressure monitor, including cables, than
the recommended separation distance calculated from the equation appli-
cable to the frequency of the transmitter.
Recommended separation distance:
d=
Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150 kHz to d= 80 MHz to 800 MHz
80 MHz
800 MHz to 2.5 GHz
Radiated RF 3 V/m 3 V/m What is the maximum output power rating of the transmitter in watts (W)?
IEC 61000-4-3 80 MHz to According to the transmitter manufacturer, the recommended separation is...
2.5 GHz ration distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnet.
magnetic site survey,ashould be less than the compliance level in each fre-
quency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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 Guidance and manufacturer's declaration – electromagnetic immunity
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
Radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be conducted.
sidered. If the measured field strength in the location in which the SBM52 blood pressure monitor is used exceeds the
applicable RF compliance level above, the SBM52 blood pressure monitor should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
SBM52 blood pressure monitor.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the
EQUIPMENT or SYSTEM – for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF communications equipment and the SBM52
blood pressure monitor
The SBM52 blood pressure monitor is intended for use in an electromagnetic environment in which radiated RF disturbances...
bances are controlled. The customer or the user of the SBM52 blood pressure monitor can help prevent electroma-
gnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the SBM52 blood pressure monitor as recommended below, according to the maximum output
power of the communications equipment.
Separation distance according to frequency of transmitter
(m)
Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
power of transmitter
d= d=
(W)
0.01 0.117 0.117 0.234
0.1 0.370 0.370 0.740
1 1.170 1.170 2.340
10 3.700 3.700 7,400
100 11.7 11.7 23.4
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maxi-
mum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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