Welby BDH 612 User manual

ID: #07177
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User-friendly
Manual
WRIST BLOOD PRESSURE MONITOR
TENSIÓMETRO DE MUÑECA
User Manual
Manual
del usuario
English ...06
Español ..63

Dok./Rev.-Nr. 196237_20180316
Contents
Overview ........................................................................................................................... 4
Use...................................................................................................................................... 5
Package contents/device parts ....................................................................................... 6
General information ......................................................................................................... 7
Reading and storing the user manual ......................................................................................7
Explanation of symbols................................................................................................................7
Safety................................................................................................................................ 11
Proper use .....................................................................................................................................11
Safety instructions......................................................................................................................16
Battery notes................................................................................................................................24
First use ............................................................................................................................27
Checking the blood pressure monitor and package contents ...........................................27
Inserting or changing batteries .............................................................................................. 28
System settings........................................................................................................................... 29
Performing a measurement........................................................................................... 33
Fitting the cuff ............................................................................................................................ 34
Starting the measuring process.............................................................................................. 35

Automatic inflation function .................................................................................................... 38
Fast deflation during the measurement................................................................................ 38
Irregular heart beat........................................................................................................ 38
Function of and access to the measurement memory.................................................. 39
Deleting the data in the measurement memory ..........................................................40
Information about blood pressure.................................................................................41
Blood pressure classification according to the WHO............................................................. 41
Display of errors and low battery .................................................................................. 43
Technical malfunctions, troubleshooting .....................................................................44
Notes on electromagnetic interference immunity .......................................................46
Cleaning and maintenance ............................................................................................ 56
Cleaning the cuff .........................................................................................................................57
Storage ............................................................................................................................58
Technical data ................................................................................................................. 59
Manufacturer information.............................................................................................. 62
Disposal ........................................................................................................................... 62
Disposing of the packaging...................................................................................................... 62
Disposing of the blood pressure monitor .............................................................................. 62

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ID: #07177
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User-friendly
Manual
WRIST BLOOD-PRESSURE MONITOR
TENSIÓMETRO DE MUÑECA
User Manual
Manual
del usuario
English ....06
Español ...63
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Package contents⁄device parts
1Display 12 Indicator for diastolic blood pressure
2Storage box 13 Pulse rate indicator
3Battery (type AAA), 2× 14 Indicator for measurement classification according to the WHO
4User manual 15 Symbol for current heart pulse:
Symbol for cardiac arrhythmia:
5Battery compartment 16 Indicator for “kPa” unit of blood pressure (kilopascal)
6Cuff 17 Low battery indicator
7M2 button 18 “” indicator, the device automatically calibrates itself
8Start/Stop button 19 “A” indicator: appears on the display when the average value
of the last 3 measurements is shown
9M1 button 20 Indicator of the memory group for a user (M1, M2)
10 “Month/Day” and “Hour/Minute”
(alternating display) 21 Battery compartment cover
The delivery contents include two LR6
(AAA) 1.5 V batteries.

General information
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General information
Reading and storing the user manual
This user manual accompanies this wrist blood pressure monitor BDH 612 (hereinafter referred to
only as the “blood pressure monitor”). It contains important information about start-up and
handling.
In order to avoid problems and incorrect operation, read the user manual carefully before using
the blood pressure monitor. This particularly applies to the safety instructions. Failure to follow this user
manual may result in severe injury or damage to the blood pressure monitor. Store the user manual for fu-
ture use. Make sure to include this user manual when passing the blood pressure monitor on to third parties.
Explanation of symbols
The following symbols and signal words are used in this user manual, on the blood pressure monitor or on
the packaging.

General information
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WARNING!
This signal symbol/word designates a hazard with moderate risk, which may result in death or severe injury
if not avoided.
CAUTION!
This signal symbol/word designates a hazard with low risk that, if not avoided, may result in minor or mod-
erate injury.
NOTICE!
This signal word warns against potential damages to property.
This symbol provides you with useful supplementary information about use.

General information
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Type BF (body float) protection against electrical shock. A type BF application equipment
with greater protection against electric shock to the body, but not directly to the heart.
The cuff is the applied part.
This symbol indicates that you should read the user manual and hold onto it.
2018-02
This symbol identifies information from the manufacturer (see chapter “Manufacturer
information”).
This symbol marks the serial number of the blood pressure monitor.

General information
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This symbol marks devices, which emit non-ionizing electromagnetic radiation (see chap-
ter “Electromagnetic compatibility”).
IP 22 Meaning of the first digit: Protected against solid foreign bodies with a diameter greater
than 0.1" (2.5mm). Protected against access with a finger. Second digit: Protection against
dripping water falling vertically when the housing is tilted up to 15°.
500 hPa
1060 hPa
Max. atmospheric pressure for storage and transport: 500–1,060hPa
-20°C
50°C Storage/transport temperature: –4°F–122°F (–20 °C–50°C)

Safety
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15%
85%
Max. humidity for storage and transport: 15%–85% (per cent)
Safety
Proper use
The blood pressure monitor is only designed for the non-invasive measurement of systolic diastolic blood
pressure and pulse rate of adults using the oscillometric method. The results are shown on the display of the
blood pressure monitor.
No special training or knowledge is needed for the application of the wrist blood pressure monitor.
The blood pressure monitor issues a warning in the event of possible cardiac arrhythmia. The levels mea-
sured are classified and rendered in accordance with the guidelines of the WHO (World Health Organization).
The blood pressure monitor is not intended to be used for infants and children.

Safety
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The blood pressure monitor is exclusively intended for private use and is not suitable for commercial or clin-
ical use.
Only use the blood pressure monitor as described in this user manual. Any other use is deemed improper
and may result in damage to property or even personal injury. The blood pressure monitor is not a children’s
toy.
The manufacturer or vendor accepts no liability for damage caused by improper or incorrect use.
What properties does a blood pressure monitor have?
After every measurement, the blood pressure monitor automatically saves the respective values for systolic
blood pressure, diastolic blood pressure, pulse rate and risk category together with the date and time. Up
to 90 data records per user can be saved for two different users. If the maximum number of 90 data records
per user has been reached, the respective oldest data record will be deleted and the new data record will be
saved in the first slot.

Safety
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What is blood pressure?
The blood pressure of the human body is constantly changing, which is attributed to physical or mental
aspects (e.g. disease, physical exertion, stressful situations, fear, caffeine, nicotine, alcohol etc.). The season,
time of day, cold or heat can also affect one’s blood pressure. Please consult your physician for specific infor-
mation about your blood pressure.
Information about the oscillometric measurement method
This blood pressure monitor uses the oscillometric method to measure the systolic and diastolic blood pres-
sure and pulse rate. This method is recommended for persons over the age of 18 years, but not for children
or infants. This device serves to measure the systolic and diastolic blood pressure and heart rate of adults in
a non-invasive manner. The device uses the oscillometric method.
Functional principle
This device uses oscillometric technology with a fuzzy algorithm to measure arterial blood pressure and the
pulse rate. The cuff is secured around the arm and automatically inflated by the air pump. The sensor locat-
ed on the device detects the slightest fluctuations in pressure in the cuff, which result from the expansion
and contraction of the arteries in the arm in response to every heart beat. The amplitude of the pressure
waves is measured, converted to millimeters of mercury and shown as a digital value. Important: This device
is unable to provide reliable measurements if it is stored at temperatures or in the presence of moisture

Safety
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exceeding the specifications in the section “Technical data”. The fuzzy algorithm is the processing algorithm,
which considers the special characteristics of every heart beat and enables a higher level of measurement
accuracy.
Notes on use
1. It is important to mention that arterial blood pressure is subject to substantial fluctuations. Arterial blood
pressure measurements depend on numerous factors. Blood pressure generally tends to be lower in sum-
mer and higher in winter. Arterial blood pressure changes with the atmospheric pressure and is significantly
affected by numerous factors. For example physical exertion, emotional excitability, stress, meals etc. med-
ication, alcohol and tobacco can significantly affect the blood pressure of a person. If the blood pressure
is measured in the hospital, the reading is generally higher than at home. This is particularly severe with
patients; in the medical field, this phenomenon is known as white coat hypertension. Blood pressure in-
creases at low temperatures, which is why it is better to measure blood pressure at room temperature (ap-
proximately 68°F (20°C)). If this device is stored at low temperatures, it must be stored at room temperature
for at least 1 hour before taking the measurement. Otherwise it may not be accurate. The blood pressure
varies depending on the age and person; it is recommended to write down the individual blood pressure
measurements on a daily basis so that you can consult your physician to determine which blood pressure is
normal for you.

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2. Patients suffering from cardiovascular diseases perform the measurements as instructed by their physi-
cian. Under no circumstances should you change the dosage of any medication prescribed to you by your
physician!
3. For patients with arrhythmia, premature heart beats, atrial fibrillation, arteriosclerosis, hypoperfusion, di-
abetes, nephropathy, a weak pulse, pregnant patients or patients with significant fluctuations in their heart
rate, it may be difficult to measure the blood pressure exactly. Please consult a qualified physician to inter-
pret your blood pressure measurements.
4. For an accurate measurement, you must not speak while taking the measurement. The measurement
should be performed in peaceful surroundings and at room temperature. Refrain from eating or smoking
before taking a measurement. This device is equipped with a standard cuff, which can be used for arm sizes
of 4.92–8.07" (12.5–20.5cm).
5. It is recommended to take repeat measurements at 3-minute intervals so that you can calculate the av-
erage for a more accurate overall measurement. Patients with arteriosclerosis may require longer intervals
between measurements (10–15 minutes) as the elasticity of vessels declines significantly as the disease pro-
gresses. Furthermore, 10–15 minutes is a suitable interval for patients with long-term diabetes.

Safety
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Safety instructions
WARNING!
Danger for children and persons with impaired physical, sensory or mental capaci-
ties (e.g. partially disabled persons, older persons with reduced physical and men-
tal capacities) or lack of experience and knowledge (e.g. older children).
− This blood pressure monitor must not be used by children under the age of eighteen
years.
− Keep the blood pressure monitor as well as its accessories away from children.
− This blood pressure monitor may be used by children ages 15 and over as well
as persons with impaired physical, sensory or mental capacities or those lacking
experience and knowledge if they are supervised or have been instructed in how
to safely use the blood pressure monitor and have understood the risks associated
with operating it. Children must not play with the blood pressure monitor.

Safety
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Cleaning and user maintenance must not be performed by children without supervision.
− Do not let children play with the packaging wrapper. Children may get caught in it
when playing and suffocate.
WARNING!
Risk of injury!
Improper use of the blood pressure monitor may result in injury.
− Only use the blood pressure monitor for its intended purpose. Do not misuse in any
way.
− This blood pressure monitor cannot serve as a substitute for medical advice or treat-
ment! The measurements taken are only for reference. If you experience problems
with your health, it is imperative that you consult your physician! Do not take any
medications based on measurements or do not stop taking any medication without
having first consulted your physician!

Safety
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− Check the blood pressure monitor for damage before each use. If there is an error or
a defect (e.g. caused by children, pets or pests), the blood pressure monitor must not
be used.
− The blood pressure monitor is not suitable for infants, children or individuals who
cannot express their intentions.
− The blood pressure monitor is not suitable for people with severe cardiac arrhyth-
mia.
− People with serious circulation problems may experience discomfort. Consult a phy-
sician before you use the blood pressure monitor.
− Contact your physician if test results regularly indicate abnormal readings. Do not
attempt to self-treat these symptoms without consulting a physician.
− Before use, consult a physician if you have any doubts about using the blood pres-
sure monitor.
− Measuring blood pressure and pulse rate with the blood pressure monitor is not a
substitute for medical diagnosis and treatment.

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− Keep all liquids away during use and in particular never immerse the blood pressure
monitor in liquids. Otherwise, injury and detrimental health effects may result due to
a short-circuit.
− Do not use the blood pressure monitor in bed or when sleeping.
− Consult your physician before using the blood pressure monitor for the first time if
any of the following circumstances apply
a. in the event of injuries to your arm, b. in the event of wounds to your arm that
have not healed yet, c. in the event of illnesses affecting the arm area, d. in the event
of abnormalities in the arm area, e. in the event of pain in the arm area for unknown
reasons, f. if areas of the arm are not sensitive to pain, g. in the case of persons with
metal and implants in the arm.
− Do not use the device if it is damaged. Using a damaged device could result in injury,
pose serious risks and result in inaccurate measurements.
− This blood pressure monitor is not recommended for persons with severe cardiac
arrhythmia.

Safety
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− If you experience any irregularities (e.g. allergies) while using the device, immedi-
ately stop using it and consult your physician.
− Misuse and use other than the intended use must be avoided.
− The measurement can only be performed on the wrist of an adult.
− Keep this user manual for the entire service life of the product for subsequent
consultation and also include it if you pass the blood pressure monitor on to third
parties. Make sure that the user manual is also accessible to third parties. The user
manual is part of the blood pressure monitor. When passing it on to third parties, also
inform them of the risks associated with the device.
− In general, you should consult your physician if you have any questions relating to
the measurements taken with the blood pressure monitor.
− The product is not intended for small children or persons who are not able to express
their intentions.
− Children or persons, who lack knowledge and/or experience handling the device or
with impaired physical, sensory and/or mental abilities, must not use or play with