Hartmann Veroval compact Manual

DE DE Upper arm blood pressure monitor
Dear customer
Thank you for choosing a HARTMANN blood pressure monitor. The Veroval® BPU 22 is a quality product intended for
fully automatic blood pressure measurement on the upper arm of adults and is suitable for clinical and domestic use.
Requiring no preliminary settings, this blood pressure monitor easily and automatically inflates for simple, quick and
reliable measurement of the systolic and diastolic blood pressure and the pulse rate.
The monitor also indicates if it detects an irregular heartbeat.
We wish you the best of health.
Please read these instructions for use carefully before handling the device for the first time. Correctly measuring
your blood pressure depends on an appropriate handling of the device. These instructions for use are designed to
teach you each step in taking your own blood pressure measurements using the Veroval® BPU 22. You will be given
important and useful hints to ensure that you obtain reliable results for your personal blood pressure profile. Use the
monitor in accordance with the information provided in the instructions for use. Please store these instructions carefully
and ensure other users can access them. Check the packaging for any damage and that the contents are complete.
Package contents
• Blood pressure monitor
• Universal upper arm cuff
• 4 x 1.5 V AA batteries
1
• Storage bag
• Instructions for use with warranty certificate
1. Device and display description 5
3
Blood pressure monitor
1 Extra large LCD display
2 START/STOP button
4
M
3 Memory button for User 1
4 Memory button for User 2
5 Cuff connector socket
6 Battery compartment
8
Cuff 9 6
7
7 Cuff with application instructions
8 Size indicator to correctly fit cuff
9 Cuff plug
10 Cuff tube 5
10
Display
11 Systolic blood pressure
12 Diastolic blood pressure
17
13 Pulse rate
14 Flashes when the device is measuring and the pulse rate is detected
18
15 Irregular heartbeat symbol
16 Cuff fit check symbol
17 Battery symbol
18 Traffic light system for your values/progress bar
19 Average value (A), morning (AM), evening (PM) /
memory space number 19
M
20 User memory
20
21 Date and time display
2. Important information
16 15 14
See table on extra page.
Important instructions for use
Intended use
The fully automatic blood pressure monitor Veroval® BPU 22 is intended for clinical and home use for the non-invasive
measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is
wrapped around the upper arm.
The use of the device does not require a specific knowledge or professional ability.
Intended user
The patient is the intended operator, except in case of patients that require special assistance.
Patient population
• Adults whose upper arm circumference is within the range indicated on the cuff.
• Only use the monitor to take blood pressure measurements on the upper arm. Do not place the cuff on other areas of
the body.
• Only use the supplied cuff or an original replacement cuff. The measured values may otherwise be incorrect.
• If measured values are questionable, repeat the measurement.
• Do not leave the monitor unattended near small children or persons who cannot operate it themselves. There
is a risk of strangulation if the cuff tube becomes wrapped around the neck. Swallowing small parts that have
detached from the device can also result in suffocation.
• Do not under any circumstances carry out blood pressure measurements on newborns, babies or toddlers.
• Do not use the monitor for diagnosis in clinical situations where the patient is in immediate danger.
• Please note that the pressure build-up in the cuff can lead to temporary disruption of medical devices being
used at the same time on the same arm.
• The function of the arm on which the cuff is placed may become impaired during inflation.
• If you are carrying out the measurement on another person, please ensure that using the blood pressure
monitor does not have a lasting negative effect on the blood circulation.
• 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.
• Taking measurements too often within a short time period as well as maintaining continuous cuff pressure can
disrupt the blood circulation and cause injuries. Please take a break between measurements and do not bend or
fold the air tube. If the monitor malfunctions, remove the cuff from the arm.
• Always consult your doctor about if and when the blood pressure monitor can be used by pre-eclampsia
patients during pregnancy.
• Always consult your doctor about if and when the blood pressure monitor can be used by persons who have had
a mastectomy or lymph node clearance.
• If a possible allergic skin reaction occurs on the arm where the cuff is used, discontinue its use and consult a
physician.
• Do not use the blood pressure monitor together with a high frequency surgical device.
• The device is not intended for use in vehicles (e.g. ambulances) or helicopters.
Contraindications
• Please do not place the cuff over a wound as this may cause further injuries.
• If an intravenous treatment is being carried out or a venous catheter is inserted in the arm, blood pressure
• measurements can lead to injury. Never use the cuff on the arm to which these conditions apply.
• If you are prone to hematoma, do not put on a cuff nor carry out a blood pressure measurement.
• Do not use the blood pressure monitor in the absence of a full arm.
Important instructions for self-measurements
• Even minor changes in internal and external factors (e.g. deep breathing, stimulants, talking, excitement,
environmental factors) can lead to fluctuations in blood pressure. This explains why deviating values are often
measured at the doctor or pharmacist.
• Measurement results fundamentally depend on the measurement location and the position of the patient (sitting,
standing, reclining). They are also influenced by e.g. physical activity and physiological preconditions of the patient.
For comparable values, carry out the measurement in the same location and in the same position.
• Cardiovascular disease can result in erroneous readings or lower the accuracy of the measurement. The accuracy may
also be affected if you have very low blood pressure, diabetes, circulatory disorders and arrhythmias and chills or
tremors.
Consult your doctor before measuring your own blood pressure if ...
• you are pregnant. Blood pressure may vary during pregnancy. Regular blood pressure monitoring is particularly
important if you have high blood pressure, because elevated values may affect foetal development. Always check
with your doctor if and when you should measure your own blood pressure, especially if you suffer from pre-
eclampsia.
• you have diabetes, liver function disorders or narrowing of blood vessels (e.g. arteriosclerosis, peripheral arterial
disease) as these may cause anomalous values.
• you have certain blood disorders (e.g. haemophilia) or severe circulatory disorders or are taking blood-thinning
medication.
• you are on dialysis or taking anticoagulant medication (anticoagulants), platelet aggregation inhibitors or steroids.
• you wear a pacemaker, which may cause anomalous values. The blood pressure monitor itself does not affect
a pacemaker. Please note that the pulse rate displayed is not suitable for checking the frequency of pacemakers.
• you tend to bruise easily and/or are sensitive to pressure pain.
• you suffer from severe heart rhythm disorders or cardiac arrhythmias. Due to the oscillometric measurement method
used, incorrect measured values may be obtained in some cases or it may not be possible to measure blood pressure.
• this symbol appears often, it may indicate heart rhythm disorders. Please consult your doctor in that case. Severe
heart rhythm disorders may sometimes produce false measurements or reduce the measurement accuracy. Please
discuss with your doctor whether taking your own blood pressure is appropriate for you.
• The readings taken by you are for your information only – they are not a substitute for a medical examination. Discuss
your measured values with your doctor and never make a medical decision based on these measurements (e.g.
medications and their dosages).
• Taking your own blood pressure is not a substitute for medical treatment. Do not interpret your measured values
yourself and do not use them for self-prescribed treatment. Take readings based on the instructions of your doctor
and trust his or her diagnosis. Take medication only as prescribed by your doctor and do not alter the dose on your
own accord. Discuss with your doctor the appropriate time to measure your blood pressure.
An irregular heartbeat is present when the heart rhythm deviates by more than 25 % from the median
heart rhythm. The contraction of the heart muscle is stimulated by electrical signals. A disorder of these
electrical signals is called an arrhythmia. This may be due to a genetic predisposition, stress, age, lack of
sleep, exhaustion or similar factors. A doctor can establish whether an irregular heartbeat is the result of an
arrhythmia.
Heart rhythm disorders are disturbances of the normal rate or rhythm of the heartbeat. A distinction should be made
between mild and severe heart rhythm disorders. This can only be determined by a special examination carried out by a
doctor.
Power supply (batteries, power supply unit)
• Observe the polarity labels plus (+) and minus (-).
• Only use high-quality batteries (see specification in Chapter 11 ´Technical data´). If you use low-quality batteries, we
can no longer guarantee the specified number of measurements.
• Never mix old and new batteries or batteries from different manufacturers.
• Remove flat batteries immediately.
• Replace batteries if the battery symbol remains illuminated.
• Always replace all the batteries at the same time.
• If you do not intend to use the monitor for a longer period of time, you should remove the batteries to prevent
possible leakage.
• If you use the monitor with the power supply unit, position the monitor so that you can disconnect the power supply
at any time.
Information about batteries
• Choking hazard
Small children could swallow batteries and suffocate on them. Keep the packaging, batteries and the monitor
out of the reach of children.
• Risk of explosion
Do not throw batteries into a fire.
• Batteries must not be charged or short-circuited.
• If a battery has leaked, wear protective gloves and clean the battery compartment with a dry cloth. If liquid
from a battery cell comes into contact with skin or eyes, clean the affected area with water and seek medical
attention if necessary.
• Protect batteries from excessive heat.
• Do not disassemble, open or crush batteries.
Safety information concerning the device
• This blood pressure monitor is not waterproof.
• This blood pressure monitor is made of high-quality electronic precision components. The accuracy of the measured
values and the lifetime of the device depend on careful handling.
• Protect the device from violent shaking, hitting or vibrations and do not let it drop on the ground.
• Do not bend or fold the cuff excessively.
• Never open the device. The device must not be modified or dismantled, and must not be repaired by the user. Repairs
may only be carried out by authorised specialists.
• Do not inflate the cuff when it is not properly applied to the upper arm.
• Use the device only with the approved upper arm cuff. The device may otherwise sustain external or internal damage.
IFU_9254251_081223.indd 1 IFU_9254251_081223.indd 1
• The cuff tube may only be removed from the unit by pulling on the corresponding connector plug. Never pull on the
tube itself.
• Do not expose the device to extreme temperatures, humidity, dust or direct sunlight as this may cause it to
malfunction.
• Keep the packaging, batteries and device out of reach of children.
• Protect the device and cuff against contact with pets and pests in order to avoid damage.
• Please comply with the storage and operating conditions defined in Chapter 11 ´Technical data´. Storing or using
the device outside the specified temperature and humidity range can affect the accuracy of the measurement or the
function of the device.
• If the device was not stored within the minimum/maximum permissible storage conditions, a waiting period of at
least 2 hours must be observed before using it under the specified operating conditions (Chapter 11 ´Technical data´)
or an ambient temperature of approx. 20 °C.
• Do not use the device in explosive environments with inflammable gases or concentrated oxygen.
Instructions regarding electromagnetic compatibility
• The device is suitable for use in all environments listed in these instructions for use, including domestic
environments.
• It may only be possible to use the device to a limited extent 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. However, if it is necessary to use the device in the manner described above, this device and the other
devices must be monitored to ensure that they are working properly.
• The use of accessories other than those specified or provided by the manufacturer of this device may result in
increased electromagnetic emissions or a decrease in the device's electromagnetic immunity and lead to faulty
operation.
• Failure to comply with the above can impair the performance characteristics of the device.
• Do not use the device near strong electromagnetic fields and keep it away from radio equipment and mobile phones.
Portable and mobile high-frequency and communication devices, such as telephones and mobile phones, can impair
the functionality of this electronic medical device. Therefore keep a minimum distance of 30 cm.
• Further documentation in accordance with the electromagnetic compatibility standard can be requested from the
manufacturer or the customer service (contact details see Chapter 10).
Instructions for the measurement function check
Every Veroval® device has been carefully tested by HARTMANN for measurement accuracy and has been developed with a
view to a long service life. We recommend carrying out a metrological check every 2 years for devices in professional
use, for example, in pharmacies, medical practices or hospitals. Please also observe the national regulations specified
by the legislator. Metrological checks may only be carried out by the competent authorities or authorised maintenance
providers against cost reimbursement.
Disposal information
• This product (monitor and cuff) is subject to the European Directive 2012/19/EU on Waste Electrical and Electronic
Equipment and is marked accordingly. Never dispose of electronic equipment in your household waste. Please
obtain information about your local regulations on the proper disposal. This protects the environment and
human health.
• The batteries comply with the European Directive 2013/56/EU. To protect our environment, empty batteries
2
must not be disposed of in household waste. Please comply with the relevant waste disposal regulations or use public
collection points, recycling points or electronic retailers.
3. Blood pressure information
Two values must be measured to determine blood pressure:
• Systolic (upper) blood pressure, which is produced when the heart contracts and pumps blood into the blood vessels.
• Diastolic (lower) blood pressure, which is produced when the heart is expanded and fills with blood again.
• Blood pressure values are displayed in mmHg.
For improved assessment of the results, a traffic light system is located on the left side of the Veroval® BPU 22 which is
a direct result indicator, making it easier to categorise the measured value. The World Health Organisation (WHO) and the
21
European Society of Cardiology (ESC) & European Society of Hypertension (ESH) have developed the following summary
for classifying blood pressure values:
Results indicator Evaluation Systolic pressure
11
Red Grade 3 hypertension above 179 mmHg
Orange Grade 2 hypertension 160 – 179 mmHg
12
Yellow Grade 1 hypertension 140 – 159 mmHg
Green High normal 130 – 139 mmHg
13
Green Normal 120 – 129 mmHg
Green Optimal up to 119 mmHg
Classification of blood pressure taken in practice and definition of hypertension grade (source: 2018 ESC/ESH guidelines)
• Established hypertension (high blood pressure) is defined as having a systolic value of at least 140 mmHg and/or
a diastolic value of at least 90 mmHg.
• In general, low blood pressure (hypotension) is defined as a systolic value below 105 mmHg and a diastolic value
of 60 mmHg. However, the threshold between normal and low blood pressure (hypotension) is not as accurately
specified as the threshold for high blood pressure (hypertension). Hypotension may be associated with symptoms
such as dizziness, fatigue, tendency to faint, visual disturbances or high pulse rate. In order to ensure that
hypotension or the corresponding symptoms are not attendant symptoms of serious illness, a doctor should be
consulted in case of doubt.
Constantly elevated blood pressure significantly increases the risk of developing other disorders. Physical
consequences of high blood pressure, e.g. heart attack, stroke and organ damage, are the most common
causes of death worldwide. Daily blood pressure monitoring is therefore an important measure that can
help to protect you from these risks. You should discuss this with your doctor, especially if you have
frequently elevated or borderline blood pressure values (see Chapter 3 ´Blood pressure information´). Your
doctor will initiate appropriate measures.
4. Preparing the measurement
Inserting/changing the batteries
• Open the battery cover on the bottom of the device. Insert the batteries (see Chapter 11 ´Technical data´). Ensure
correct polarity (+ and –) when inserting the batteries. Close the battery lid.
the date and time as described below.
• If the 'Change battery' symbol is permanently illuminated, blood pressure can no longer be measured and you
need to replace all the batteries.
Setting the date, time
It is very important that you set the date and time correctly. This is the only way to save your measured values
correctly, with the date and time, for subsequent retrieval. This is also important for correctly using all the
memory and analysis functions.
• To switch to settings, reinsert the batteries or press the START/STOP button
Hours
The hour format flashes on the display.
Select the desired hour format using the Save buttons / and confirm using the
START/STOP button .
Date
The display shows the year (a), the month (b) and the day (c).
Depending on the display, use the Save buttons / to select the year, the month or the day
and confirm using the START/STOP button .
If the 12-hour format is selected, the month is displayed before the day.
Time
The hour (d) and the minute (e) flash in sequence on the display.
Depending on the display, use the Save buttons / to select the current hour or minutes and
confirm using the START/STOP button .
The device switches off automatically once all data has been set.
The measured values will remain in the memory when the batteries are changed. The date and time
settings will also be saved.
5. Measuring your blood pressure
The 10 golden rules of blood pressure measurement
Many factors play a role in blood pressure measurement. These ten general rules help you to correctly carry out the
measurement.
1. Rest for about 5 minutes before
measuring your blood pressure.
Even working at your desk increases
blood pressure by an average of
about 6 mmHg systolic and 5 mmHg
diastolic.
3. Do not measure when you have
a strong urge to urinate. A full
bladder can increase blood pressure
by about 10 mmHg.
5. If you are using a wrist monitor,
hold the cuff at heart height during
measurement. The cuff of an upper
arm monitor is naturally positioned at
the correct height.
7. Wait for at least one minute
between each measurement so
that the blood vessels are ready,
by removing the pressure applied
to them.
9. Take measurements regularly. Even
if your values have improved, you
should continue to check them for
monitoring purposes.
Applying the blood pressure monitor
• Before applying the cuff, insert the cuff socket into the connector socket on the left side of the device.
• Do not mechanically constrict, compress or bend the sleeve tube.
• Blood pressure must be measured on a bare upper arm. If the cuff is completely open, thread the end of the cuff
through the metal ring to form a loop. Position the cuff on the upper arm so that the lower edge is 2–3 cm above the
crook of the arm and above the artery. The tube points to the centre of the palm.
• Now bend your arm slightly, grasp the free end of the cuff, wrap it firmly round your arm and close the hook-and-loop
fastener.
The cuff should fit firmly but not tightly. You should be able to insert two fingers between the arm and the cuff.
Make sure the tube is not bent or damaged.
Important: It is essential that the cuff is correctly applied to obtain correct measurements. The cuff included with
the device is a universal cuff for upper arm circumferences of 22 to 42 cm. The white arrow must point to an area
within the sizing scale. If it is outside the range, it is not possible to guarantee a correct measurement result.
This innovative Veroval® device with Comfort Air Technology ensures comfortable measurement. The
individual inflation pressure is determined independently for each measurement and depends on the
corresponding systolic blood pressure value. This allows for more comfortable upper arm measurements.
Carrying out the measurement
• You should take your blood pressure in a quiet place, in a relaxed and comfortable seated position.
• Measurement can be taken on the right or left arm. We recommend you perform the measurement on the left upper
arm. Over the long term, the arm giving higher readings should be used for blood pressure monitoring. However, if
there is a very clear difference between readings on either arm, you need to check with your doctor which arm you
should use for the measurement.
• Always measure on the same arm and place your forearm in a relaxed position on a support.
• We recommend that you measure your blood pressure while sitting with your back against the back of the chair. Place
both feet flat on the floor next to each other. Do not cross your legs. Relax your forearm and hand with your palm
facing upwards on a support and make sure the cuff is at the height of your heart.
• Do not measure your blood pressure after taking a bath or playing sports.
• Do not eat, drink or exercise for at least 30 minutes before the measurement.
• Please wait for at least one minute between two measurements.
Starting the measurement
• Start a measurement only after applying the cuff because the cuff may otherwise be damaged by the excess pressure
that is created. Press the START/STOP button
date, indicates that the device is carrying out an automated check and is ready for use.
• Check the display segments for completion (see Chapter 1 ´Device and display description´).
• After about 0.5 seconds the cuff inflates automatically. If this inflation pressure is insufficient or if interference is
experienced during measurement, the device will increase pressure to the appropriate higher pressure value in
increments of 40 mmHg. During inflation, the results indicator on the left of the display also increases at the same
time.
• If the cuff has been applied firmly enough on the arm, the cuff symbol appears
does not appear in the display, the cuff has not been fitted securely enough and the error message ´ ´ appears on
the display after a few seconds.
Do not speak or move for the duration of the measurement.
• As the cuff pressure is released, the heart symbol
display.
• After the measurement is complete, the systolic and diastolic blood pressure as well as the
pulse rate appear simultaneously.
• In addition to the measured values, the time, date, the associated user memory or as well as the associated
memory numbers (e.g. [M]05) are shown. While the result of the measurement is displayed, you can assign the values
to the corresponding user memory by pressing the or button. If you do not assign the values to the corresponding
user memory, the measured values are automatically stored in the user memory shown on the display.
• You can use the results indicator on the left of the display to classify your measurement result (see table in Chapter 3
´Blood pressure information´).
• To switch off the device, press the START/STOP button
1 minute.
If you wish to stop the measurement for any reason, simply press the START/STOP button
measurement process is interrupted and cuff pressure is automatically released.
• If irregular heartbeat was detected during the measurement, the display will show the heart symbol
measurement may also have been disrupted by body movement or speaking. It is best to repeat the measurement. If you
see this symbol regularly when measuring your blood pressure, we recommend that your doctor checks your heart rhythm.
6. Memory function
User memory
• The Veroval® BPU 22 stores up to 100 measurements in each user memory. The most recent measurement is always
saved together with the date and time in memory slot no. 1 and all older saved values are moved up one memory slot.
Once all memory slots are occupied, the oldest value is deleted.
• The device has two memory buttons, and , that are used to record the measurement results for two separate
users. represents the measured values for the first user, represents the measured values for the second user. After
the measurement is finished, you can assign the measured value to the respective person by pressing and . This
assignment can be made for 10 seconds. If you do not assign them, the measured value is automatically stored in the
user memory that is currently displayed.
• The time of the measurement is also saved, along with each of the blood pressure values, to enable the morning and
evening averages to be determined. The time saved in the device must therefore be set correctly to the actual time
(see Chapter 4, section ´Setting the date and time´).
Veroval® BPU 22 features the following measurement data storage functions (corresponding to the guidelines of the
Diastolic pressure
European Society of Hypertension (ESH)):
• Individual measured value memory
and/or above 109 mmHg
• Average value of all measured blood pressure values per user
and/or 100 – 109 mmHg
• Average value of the morning values
• Average value of the evening values
and/or 90 – 99 mmHg
and/or 85 – 89 mmHg Veroval® BPU 22 follows the recommendations of the European Society of Hypertension (ESH) and
differentiates between measurements taken in the morning and those taken in the evening. This
and/or 80 – 84 mmHg
distinction is medically relevant because blood pressure changes over the course of the day. With this
information, your doctor is more likely to identify the right treatment for you if you should need medicinal
and up to 79mmHg
treatment for high blood pressure.
• The memory recall is activated by pressing the or button with the device switched off. For values saved in the first
user memory button, press the button, for the second user memory press the memory button.
Average values
• After selecting the respective user memory, the corresponding symbol or and ´
´ appear on the display. The average value of all the data stored for the particular user
memory is displayed.
• By pressing the button again (or the button if you are in user memory 2), the average
values for all morning measurements ´ ´ (00:00 to 11:59) for the past 7 days (including
the current day) appear.
• By pressing the button again (or the button if you are in user memory 2) the average
or flash on the display. Set
values for all evening measurements ´ ´ (12:00 to 23:59) taken on the last 7 days
(including the current day) appear.
• If there is no morning or evening value for the past 7 days in the memory, dashes will be
shown on the display instead of the morning or evening average values. If no values at all
for 5 seconds. Proceed as follows:
are stored in the memory, then dashes will also be displayed instead of the overall average
value.
Individual measured values
• By pressing the button again (or the button if you are in user memory 2), all memory
values can be retrieved one after the other, starting with the most recently measured
value.
• If an irregular heartbeat was detected during measurement, that information
when the measured value is retrieved from the device's memory along with the systolic and diastolic blood
pressure readings, pulse rate, time, date and year.
• You can cancel the memory recall at any time by pressing the START/STOP button
(d)
• Otherwise, the device will switch off automatically after a few seconds.
• Even if the power supply is interrupted, e.g. when changing the batteries, the stored values will still be
available.
(e)
Deleting saved readings
All data saved for each user can be deleted separately for user memory and user memory . To do so, press the button
of the corresponding user memory ( or ). The average ´A´ value will then appear on the display.
Press and hold the user memory button for 5 seconds. ´CL 00´ appears on the display. All data in the selected user
memory are now deleted. If you release the button early, no data will be deleted.
7. Explanation of error messages
Error Possible causes
Monitor cannot be Batteries are missing, inserted incorrectly
switched on or flat.
2. Do not consume any nicotine or
Cuff will not inflate The cuff connector plug is incorrectly
caffeine up to one hour before
positioned in the connector socket of the
measurement.
monitor.
Wrong cuff type connected.
4. Measure your blood pressure on
Pulse could not be detected correctly.
a completely bare upper arm and
in a comfortable upright seated
position. The blood circulation must
not be constricted by a rolled-up
Systolic or diastolic blood pressure could
sleeve, for example.
not be detected.
6. Please do not talk or move when
measuring your blood pressure.
Talking increases values by about The cuff was applied too firmly or too
6–7 mmHg. loosely or the cuff is defective.
8. The date and time are conveniently
and easily recorded with the
measured values as well as any
medications you have taken, with
the Veroval® medi.connect app.
Error during measurement.
10. Always take measurements at the
same time of day. Because a person
has about 100,000 different blood
Inflation pressure is higher than
pressure values every day, individual
300 mmHg.
measurements are not meaningful.
Only regular measurements taken at
the same time each day over
A system error has occurred.
a longer period of time give
a meaningful assessment of blood
pressure values.
The batteries are almost empty.
Implausible measured Implausible measured values often occur
values due to inappropriate handling of the
device or mistakes during the measuring
procedure.
• Switch the device off if an error symbol appears. Check for all possible causes and follow the 10 golden rules
(Chapter 5 ´Measuring your blood pressure´) as well as the instructions for self-measurement from Chapter 2
´Important information´.
• Relax for one minute and then take the measurement again.
8. Monitor maintenance
• Only use a soft, damp cloth to clean the device. Please do not use thinner, alcohol, detergents or solvents.
• The cuff can be cleaned carefully using a slightly damp cloth and mild soap solution. Do not completely immerse the
cuff in water.
• It is recommended to clean and disinfect the cuff regularly or after each use, especially when used by several users,
to prevent infection. The cuff should be disinfected, particularly on the inside, by wiping with a disinfectant. Use
a disinfectant that is compatible with the cuff materials, e.g. 75 % ethanol or isopropyl alcohol. To protect from
external influences, keep the device, the cuff and these instructions in the storage bag.
• If you store a device and cuff, do not place any heavy objects on the device and the cuff. Remove the batteries.
9. Warranty conditions
• We offer a 3-year warranty for this high-quality blood pressure monitor from the purchase date and in accordance
with the conditions listed below.
• Warranty claims must be made during the warranty period. The purchase date must be documented by an
appropriately completed and stamped warranty certificate or proof of purchase.
• Within the warranty period, HARTMANN will replace or repair free of charge any faulty device components caused by
material faults or manufacturing errors. This does not extend the warranty period.
• For local warranty conditions, please consult the local warranty certificate.
• This device is solely intended for the purpose stated in these instructions for use.
• The manufacturer is not liable for damage or injuries resulting from improper handling, use or unauthorized
interference. Accessory parts that are subject to wear and tear (batteries, cuffs, etc.) are excluded from the warranty.
Claims for compensation are limited to the value of the product; compensation for consequential damage or injury is
expressly excluded.
• In warranty cases, please send the monitor with cuff and, if applicable, the power supply unit, together with the fully
completed and stamped warranty certificate or purchase receipt directly or via your dealer to the Customer Services
department of your country.
10. Contact information for customer enquiries
. The appearance of all display segments, followed by the time and
If necessary, please contact us at the relevant address listed above for any questions regarding initial startup, use and
maintenance of the device, or to report an unexpected operating malfunction or incident. For a patient/user/third
party in the European Union and in countries with identical regulatory regime (Regulation (EU) 2017/745 on Medical
Devices); if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the
on the display. If the cuff symbol
manufacturer and/or its authorized representative and to your national authority.
Vigilance contact point for Europe: www.ec.europa.eu/growth/sectors/medical-devices/contacts/
11. Technical data
Model
flashes and the dropping pressure in the cuff is shown on the
Type
Measuring method
Display range
Measuring range
M
Display unit
Technical measurement
accuracy
Clinical measuring accuracy
, otherwise the device will automatically switch off after
Operating mode
. The inflation or
Nominal voltage
. However, the
Power supply
Expected service life
Battery capacity
Protection against electric
shock
Protection against harmful
ingress of water or solid
materials
Inflation pressure
Automatic switch-off function
Cuff
Memory capacity
Operating conditions
Storage/transport conditions
Serial number
Reference to standards
Weight
Dimensions
Legal requirements and guidelines
• The Veroval® BPU 22 conforms with the Regulation (EU) 2017/745 of the European Parliament and of the Council on
medical devices, as well as the respective national provisions, and bears the CE mark.
• The device complies with international standard IEC 80601-2-30 (Medical electrical equipment Part 2-30: Particular
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requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers).
• This product is subject to special precautionary measures with regard to electromagnetic compatibility.
• Beyond statutory requirements, the device has been clinically validated by the ESH-IP2 Protocol of the European
Society of Hypertension (ESH) and the protocol of the German society of hypertension (DHL).
Date of revision of the text:
Globalcare Medical Technology Co., Ltd.
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7th Building, 39 Middle Industrial Main Road
European Industrial Zone, Xiaolan Town
528415 Zhongshan City, Guangdong Province, P.R.C.
Phone: +86 760 22589901
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is also stored and displayed
.
Remedy
Check the batteries. If necessary, replace
with four new identical batteries.
Check the connection between the cuff
connector plug and socket.
Verify that only an approved Veroval® cuff
and connector are being used.
Check that the cuff has been positioned
correctly. Do not talk or move during
measurement.
Check that the cuff has been positioned
correctly. Do not talk or move during
measurement.
Apply the cuff so that two fingers fit
between the cuff and the upper arm.
The air tube is not correctly connected
to the monitor. Check that the connector
plug is correctly positioned. If this error
occurs frequently, you should use a new
cuff.
Please rest for at least 1 minute, then take
the measurement again (see Chapter 5
´Measuring your blood pressure´).
Please rest for at least 1 minute, then take
the measurement again (see Chapter 5
´Measuring your blood pressure´).
Contact customer service if this error
message appears.
Replace batteries.
Please refer to Chapter 5 ´Measuring
your blood pressure´ as well as the
safety information. Then repeat the Upper arm blood pressure monitor
measurement.
Purchase date
Serial number (see rating label)
Reason for complaint
Dealer's stamp
Veroval® BPU 22
GCE606
Oscillometric
0–300 mmHg
Systolic (SYS): 50–280 mmHg
Diastolic (DIA): 30–200 mmHg
Pulse: 40–199 pulse beats per minute
Displaying of correct values outside the measuring range cannot be guaranteed.
1 mmHg
Cuff pressure: ±3 mmHg
Pulse: ±5 % of the displayed pulse rate
Complies with the requirements of EN ISO 81060-2 and IEC 80601-2-30;
Korotkoff validation method: Phase I (SYS), Phase V (DIA)
Continuous mode
DC 6V
4 x 1.5V alkaline manganese (AA/LR06) batteries
20,000 measurements
Approx. 1,000 measurements
Medical-electrical equipment with internal power supply (only when batteries are
used); applied part: type BF
IP21
Comfort Air Technology:
Individual inflation pressure depends on systolic blood pressure
2 minutes after measurement/otherwise 30 sec.
Veroval® cuff for BPU 22, cuff for arm circumference of 22 to 42 cm
Model number: 30602
2x100 measurements with average of all measurements and morning/evening
average of the last 7 days
Ambient temperature: +10 °C to +40 °C
Relative humidity: <90 %, non-condensing
Air pressure: 800 hPa – 1050 hPa
Ambient temperature: –20 °C to +55 °C
Relative humidity: <90 %, non-condensing
On the rating label
IEC 60601-1; IEC 60601-1-2 (Group 1, Class B, in accordance with CISPR 11, IEC
61000-4-2, IEC 61000-4-3, IEC 61000-4-8)
Approx. 220 g (without batteries)
134(L) x 91(W) x 48(H) mm
, Version 3
Donawa Lifescience
Piazza Albania, 10
00153 Rome, Italy
https://www.donawa.com/contacts
Warranty certificate
12.12.23 11:14 12.12.23 11:14