Professional Documents
Culture Documents
Manuals EN BP6KT UMEN Rev06 20210427
Manuals EN BP6KT UMEN Rev06 20210427
BP6KT_UMEN_rev06_20210427 2
4. Patient information .............................................................................................. 19
5. Cuffs ....................................................................................................................... 22
5.1 Dimensions ..................................................................................................... 22
5.2 Using the cuff ................................................................................................. 22
6. Batteries ................................................................................................................ 24
7. Safety concerns ..................................................................................................... 25
8. Cleaning & protection .......................................................................................... 26
9. Maintenance ......................................................................................................... 27
10. Disposal .............................................................................................................. 28
11. Indications & contraindications ....................................................................... 28
11.1 Indications for ambulatory blood pressure monitoring ......................... 28
11.2 Contraindications ....................................................................................... 28
12. List of possible accessories .............................................................................. 29
Technical Specifications ....................................................................................... 30
13. Troubleshooting ................................................................................................ 31
13.1 Error codes .................................................................................................. 31
14. Meditech product warranty information ........................................................ 32
15. References ......................................................................................................... 34
16. EMC information ............................................................................................... 34
BP6KT_UMEN_rev06_20210427 3
1. Product description
The Meditech ABPM-06 ambulatory blood pressure monitor provides accurate
information on blood pressure variability, overnight dipping and morning surge
for reliable hypertension management and control.
! Caution: Federal law restricts this device to sale by or on the order of a physician.
The device can only be used on adult patients (for more information, please
see the Contraindications chapter).
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1.1 Name of parts
LCD display
Start button
Event button
Day/night button
battery compartment
sticker with the serial
number
cuff connection
BP6KT_UMEN_rev06_20210427 5
1.2 LCD display
The following table contains the information displayed on the screen of ABPM-
06.
normal state: time pulse rate value of
is displayed recently completed
(there is no measurements
measurement data (beats/minute)
in the device that is
not downloaded to
a PC)
BP6KT_UMEN_rev06_20210427 6
diastolic blood blinking heart
pressure is symbol:
displayed after measurement in
successful progress (mmHg)
measurement
(mmHg)
night mode: time is LCD check: all
displayed, and a segments are
moon symbol is displayed
visible on the LCD
PC blood pressure
communication measurement
initiated (kPa)
BP6KT_UMEN_rev06_20210427 7
clock not set
(blinking zeros on
display)
1.3 Buttons
There are 3 buttons on the front of the device:
1. Start
2. Event
3. Day/night
The patient can press any button to stop the ongoing blood pressure
measurement. This will result in the cuff being immediately and quickly deflated.
When pushed, a short beeping sound indicates that the buttons are working
properly. Some of the buttons may have more than one function. To switch
between them, press and hold the button, and release it when the required
function appears on the LCD. The function switches every 5 seconds. If the button
remains pressed after the last available function, the clock display will be shown
again and all button functions will be disabled until the button is released. For
safety reasons, automatic blood pressure measurements cannot be started when
a button is pressed, so the measurement will not start and the appropriate error
code will be stored in the data list.
Start button
- Starting manual
measurement
- LCD check
- Battery voltage check
- Switch on/off
Event button
- Sets an event marker
- Records voice memo
Day/night button
- Indicates the time of going
to sleep/waking up
- Manually switches the time
period (Day/night)
BP6KT_UMEN_rev06_20210427 8
1.3.1 Start button functions
1. Start measurement: After a 3-second-long LCD test where all segments light
up, the monitor starts a blood pressure measurement.
2. LCD test: Pressing and holding the Start button (for up to 5 seconds)
performs a screen test. During the LCD test, if the button is released, the
device will start a measurement.
3. Battery voltage measurement (Press and hold the Start button for 5 to 10
seconds): The display shows the battery voltage in Volts. If the current
voltage is higher than 2.30V, it clears the low voltage indication (if there is
one) from the screen. Fully charged batteries have a voltage of 2.5V
(displayed in the following format: 2_50).
The low voltage indication will remain on the screen until the voltage
reaches 2.4V again. If the terminal voltage drops below 2.0V, even for a
short period of time, the signal will not disappear even if it rises again
above 2.4V. In this case, the low battery sign can be removed by a battery
voltage measurement or by replacing the batteries, provided that during
the voltage measurement the terminal voltage is above the above-
mentioned limit (2.3V).
4. Power Off (Press and hold the Start button for more than 10 seconds): Two
horizontal lines appear on the screen. The device enters low power mode,
stops automatic measurements, and the buttons become inactive. To exit
this mode, press and hold the Start button for at least 5 seconds or remove
the batteries. A "Power off" event is stored in the data list.
The Event button may have the following 2 functions, depending on the device
configuration.
The patient should be informed that all events are to be recorded in the
appropriate section of the patient diary.
BP6KT_UMEN_rev06_20210427 9
for 15 seconds. Vertical lines start appearing continuously from left to right
while recording a voice memo, indicating the elapsed time. When the 8th
vertical line appears, the voice memo will stop recording. A short beep
indicates the end of the voice memo. The recording can be interrupted at
any time by pressing any of the buttons.
The operation of the Day/night button depends on how the device is programmed:
2. Manually switches the time period (available only 2 hours before the
programmed switching time)
If the Enable manual day/night shift function is checked (the function is enabled)
during programming, the patient can switch between night and day measurement
frequency by pressing the Day/night button (the moon symbol in the upper right
corner of the screen indicates that the device is in the night time period). At this
time, in the same manner as above, a change of time period occurs in the data list,
but, at the same time, the frequency of automatic measurements also changes to
the frequency of the next period. After a manual switch, it is not possible to switch
back to the previous period. The event of changing the time periods is stored in
memory only until the end of the plan. Period-change events after the end of the
plan are not stored.
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2.2 Set up the monitor
2.2.1 Insert 2 AA batteries into the monitor
After inserting the batteries, the current voltage is displayed for 10 seconds. The
typical voltage for fully charged rechargeable batteries should be over 2.5V and
for fresh alkaline batteries, over 3V. You can check the battery voltage later at any
time by holding down the Start button for 5 to 10 seconds.
ABPM-06 uses a standard USB A - mini USB B cable that allows communication
between the device and the PC. Always finish installing the software before
connecting the device to the PC! (The USB driver is installed with the software,
otherwise the PC will not recognize the device.) Even when the PC and the device
are connected with the cable, the device performs automatic measurements and
all other functions work normally.
! Warning: The device can only be connected to the computer after disconnecting
the cuff!
The machine enters communication mode when you start programming the
device or downloading measurement data with the user software. These events
are considered user interventions, therefore, an ongoing blood pressure
measurement will be interrupted by this communication and a PC Communication
error code will be stored for that measurement.
BP6KT_UMEN_rev06_20210427 11
The available USB bandwidth depends on the number and type of USB devices
connected to the computer. If you experience slowdowns or communication
problems, you may want to try removing other USB devices (if possible).
CardioVisions: Tools > Options > Communication, select ABPM-06 and click
Test.
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3.2 Program the device
- Start programming
- Create a monitoring plan that fits in with the patient's daily routine by
providing the parameters needed for the new examination
CardioVisions
Four flashing circles at the top of the display indicate that the device is currently
being programmed.
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3.3 Fit the patient with the monitor
a) Apply a proper size cuff to the patient’s non-
dominant arm and make sure that the „Artery”
indicator is over the brachial artery.
e) Provide an event log for the patient (a sample is available on the Meditech
data carrier) and inform the patient about the purpose of the examination,
expected results, and proper use of the device.
c) Establish communication between the monitor and the PC and retrieve the
measurement data.
BP6KT_UMEN_rev06_20210427 14
CardioVisions (Home screen): select your device
from the drop-down menu and click the Reading Data
icon. If you have programmed the device using manual
programming or the device was programmed using
another database, record the patient information into
the database after retrieving the data.
CardioVisions: Tools > Options > Standard reports > ABPM report
EasyABPM: Tools > Settings > Report
b) Review the report and edit it if necessary.
PLAN A): measurements are taken every 15 minutes in the daytime and every 30
minutes in the nighttime period.
PLAN B): measurements are taken every 20 minutes in the daytime and every 40
minutes in the nighttime period.
PLAN C): measurements are taken every 30 minutes both in the daytime and the
nighttime periods.
BP6KT_UMEN_rev06_20210427 15
the display to indicate that the device is being programmed. After successful
programming, 5 beeps can be heard and the selected plan is displayed again for 5
seconds. Programming may be interrupted in some cases, which the monitor
always indicates.
If the clock of the device was not set before programming (PC
Programming), the clock is set to 01.01.2001 00:00:00.
The first measurement is to check the programming of the device and is done in
the second minute after programming. The monitor always generates the plan
starting from 00:00 according to the measurement frequency specified in the
measurement plan. When the programming is done, there is a 5-minute waiting
period. After this, the first measurement will be made at the first possible time,
based on the pre-programmed plan. For example, with a 15-minute plan
programmed at 16:27, the device will add a 5-minute waiting time, so we get 16
hours 32 minutes, so the next possible time of measurement (due to the 15-
minute plan) is 16 hours 45 minutes, which is the time of the first measurement.
There are always measurements at the beginning/end of the time periods (6 am
and 10 pm). The time of the rest of the measurements is determined by the
measurement frequency. The last measurement is made exactly 24 hours after
the second measurement.
BP6KT_UMEN_rev06_20210427 16
Information displayed during manual programming:
normal state: the measurement
time is displayed Plan 2: 20/40-
minute
measurement
frequency
10-second measurement
standby: time plan 3: 30/30-
display without minute
colon measurement
frequency
measurement plan
1: 15/30-minute
measurement
frequency
CardioVisions: Go to Tools > Options > Blood pressure > Displaying blood pressure
in [kPa] units to switch between mmHg or kPa units.
BP6KT_UMEN_rev06_20210427 17
EasyABPM: Go to Tools > Settings > Analysis > Unit of pressure group to switch
between mmHg or kPa units.
The device takes the results of previous blood pressure measurements into
account when starting a blood pressure measurement. Programming the device
clears the history and, in this case, the first measurement starts at 160 mmHg.
The device can store more than 600 entries, including the data of manually and
automatically triggered blood pressure measurements as well as other event
indications, such as pressing the Event button, inserting batteries, changing the
time period, etc.
Measurement results and events will not be stored if the instrument clock
is not set or incorrect.
The device is able to repeat automatically started measurements ending with error
code E - 1 (measurement failed), if measurement repetition is enabled in the active
measurement plan. Measurements started manually and repeated
measurements are not repeated.
Depending on the type of the software, repeated measurements can be enabled
in the following ways:
BP6KT_UMEN_rev06_20210427 18
After this, there must be 2 consecutive successful measurements for the device to
again start repeating failed measurements. These 2 consecutive successful
measurements can be manual, automatic, or repeated measurements.
Depending on the type of the software, the SleepWell® feature can be enabled in
the following ways:
The internal clock of the device will continue to function even when the batteries
are discharged or removed due to the installed CR1620 lithium battery. The
battery should be replaced depending on the usage of the device, and it must be
replaced in a service center.
The CardioVisions software measures the voltage of the battery before each
programming, and if the voltage drops below a critical value, a warning is
displayed in the Home tab of the Programming window.
4. Patient information
• To avoid infection risks and for hygienic reasons, the device, the cuff, and
the tube should never contact the skin directly. Wearing a thin shirt under
the cuff is recommended.
BP6KT_UMEN_rev06_20210427 19
• Modification of the device is not allowed. Never disconnect any accessory
from the device. During the examination, report any problem or battery run
down to your physician.
• Never (re)place the cuff over wounds, dressed wounds or area of skin
irritation, infection.
• Before each measurement, the device will start its built-in motor pump to
inflate the cuff to the necessary pressure level. Pumping has a low sound
and a feeling of low vibration with the cuff becoming tighter on the arm. The
blood pressure measurement itself takes place during the stepwise
deflation that follows. The inflation phase usually takes approximately 30
seconds. Please use this time period to cease all unnecessary movement,
especially strong physical activity. Prepare to stay relaxed and keep your
arm with the cuff relaxed, slightly away from your body during cuff
deflation, until the pressure is released to zero. This will help to prevent
extreme motion disturbances to the measurement.
• Do not remove the cuff even at night. If, for some reason, the cuff does have
to be removed during the examination, when putting it back, take care to
place the cuff on the same arm in a way that the rubber tube points towards
the shoulder and the white tissue-sign (textile cuff), or the “Artery” mark (PU
fabric leather cuff) is placed above the brachial artery. Make sure that the
cuff is tight enough without causing any discomfort. If possible, use the help
of another person when replacing the cuff.
• In the unlikely event of the tube of the cuff getting disconnected from the
device, connect the air connector of the cuff to the air connector socket of
the device by gently pushing the two connectors together and turning the
connector of the cuff clockwise until it stops and clicks into place.
• Never measure anybody else’s blood pressure with the device during the
examination.
• Take care to avoid twisting the cube as it impedes the smooth flow of air.
• Take care to keep the cuff and its tube from getting tangled to prevent
strangulation, circulation problems or choking.
• If necessary (you feel pain, dizziness, or torpidity in the hand), press any
button to stop a measurement. This will result in immediate and fast cuff
deflation.
BP6KT_UMEN_rev06_20210427 20
• If you feel dizziness, angina pectoris, palpitation, or headache, press the
Start button shortly to start a manual blood pressure measurement.
• Press the Event button shortly to make a note of an event (for example,
taking medication). Such events should be recorded in the patient diary as
well.
• Voice memo recording (only on ABPM-06): Press and hold the Event button
until 3 vertical lines appear on the right side of the display with the number
of the voice memo. After releasing the button there is a 1-second-long
beeping sound after which you can record for 15 seconds. Vertical lines start
appearing continuously from left to right while recording a voice memo,
indicating the elapsed time. When the 8th vertical line appears, the voice
memo will stop recording. A short beep indicates the end of the voice
memo. The recording can be interrupted at any time by pressing any of the
buttons.
• Do not immerse the device in water or any cleaning fluid and protect it from
spills and splashes. Do not expose it to heavy rain or steam and do not wear
it in a wet environment, for example, in the shower, bath or swimming pool.
If water does get onto the device, wipe it off with a dry cloth.
• If water does get inside the device, take it off, remove the batteries, and
return the device to your physician.
BP6KT_UMEN_rev06_20210427 21
5. Cuffs
5.1 Dimensions
Name Bladder Arm circumference
dimensions range
large 15*33 cm 33-42 cm
normal 12*25 cm 25-32 cm
small 9*18 cm 18-24 cm
If the patient's arm circumference does not fall into either of the ranges in the
table above, use the cuff closest to the circumference of the arm and perform a
so-called undercuffing or overcuffing calculation.
The device automatically determines the size of the connected cuff at the
beginning of each measurement.
BP6KT_UMEN_rev06_20210427 22
When properly applied, the end of the sleeve (the one closer to the tube)
should fall in the indicated range.
Take care to avoid blocking the air flow in the tube of the cuff and twisting
the tube. Make sure the cuff and its tubing do not cause strangulation or a
circulation problem. Should the patient experience arm numbness or pain
remaining after any blood pressure measurement is completed, the cuff
should be removed to avoid permanent vascular or neural injury. The application of
the cuff over a wound can cause further injury! The application of the cuff and its
pressurization could result in injury to the patient because of temporary interference
to blood flow on any limb where intravascular access or therapy, or an arterio-venous
(A-V) shunt is present. The pressurization of the cuff can temporarily cause loss of
function of a monitoring medical equipment used simultaneously on the same limb.
No relevance can be shown in the application of the cuff and its pressurization on the
arm of the side of a mastectomy.
The cuff should be applied as tightly as is still comfortable for the patient.
Loose fitting increases the time required for each measurement and the
probability of interrupted measurements due to timeout, as the device will need
to pump more air to achieve the correct pressure. Longer measurements also
make the patient uncomfortable, and interrupted measurements reduce the
amount of data that can be evaluated. If the patient removes the cuff during the
monitoring session, it should be reapplied with appropriate tightness, with help
from another person, if necessary.
BP6KT_UMEN_rev06_20210427 23
damage to the main device, which damages are not covered by the warranty
provided by Meditech Kft.
6. Batteries
Meditech ABPM-06 is powered by two
1.5V AA standard batteries or two 1.2V
AA rechargeable batteries.
In order to change batteries, take the monitor out of the holder pouch and remove
the battery compartment cover on the backside. Place two properly charged, high-
capacity AA rechargeable batteries or two new, long-life AA alkaline batteries into
the compartment then close it.
For proper operation of the clock of the device, the sealing foil in the
battery compartment must be removed.
BP6KT_UMEN_rev06_20210427 24
If measurements do not start in due time replace the internal clock battery.
If the measurements do not start at the specified time or do not start at all, the internal
clock battery is likely to be discharged. In this case, it is necessary to have the battery
replaced by an authorized service centre. This is a non-warranty operation. Please
contact your dealer.
If the batteries run down, replace them even during a monitoring session.
Should the batteries run down during a monitoring session, they can be replaced.
Monitoring will continue and data will not be lost.
7. Safety concerns
Protection against electric shock
ABPM-06 is equipped with the necessary protection against electric shock. The
device is powered by 2 pcs of 1.5V AA batteries or 2 pcs of 1.2V AA rechargeable
batteries, which eliminate the possibility of electric shock, even in the event of
multiple device failures.
Many personal computers do not have adequate protection against electric shock
or stringent safety standards that are essential for the use of medical instruments.
For these reasons, keep a minimum distance of 1.5 meters between the patient
and the computer when using ABPM-06 with a PC. This is the required safety
distance.
Before connecting the ABPM-06 to the PC, remove it from the patient and
make sure the battery cover is in place. Otherwise, the personal computer
must meet the requirements of the EN 60950-1 standard.
! Warning: The device must be protected from radiant heat and prolonged high
temperatures!
Biocompatibility
To avoid infection risks, and for general hygienic reasons, the device, cuff and
tubing should never contact the patient's skin directly. Cuff materials meet the
related biocompatibility requirements.
Hazardous materials
Used batteries qualify as hazardous waste and should be disposed with care. The
device does not contain any materials qualified as pharmaceutical substance or
tissue of animal origin. They emit no material hazardous to humans.
BP6KT_UMEN_rev06_20210427 25
Risk of incorrect diagnosis
The intended use of the Meditech ABPM-06 is to record blood pressure and pulse
rate values. Patients should be informed about the rules of cooperative behavior,
the proper handling of the monitor, and the expected results of monitoring before
the start of the measurement. The device only provides data to support diagnostic
decisions of a qualified physician; it does not automatically provide a diagnosis of
any kind. During the evaluation of the recorded blood pressure values, possible
artefacts due to external disturbances, motion, and electrical noise should be
observed with caution and taken into account.
BP6KT_UMEN_rev06_20210427 26
Avoid any leakage into the tube when cleaning the cuff. (Plug the end of the
tube.)
Do not put the monitor into a sterilizing machine.
Do not use bleach.
Protection
! Warning: Do not immerse the appliance in water or any other liquid and do not
subject it to shocks or splashing water!
Do not expose to rain, steam or moisture. Do not use in wet environments such
as showers, baths or swimming pools. If moisture does get onto the device, wipe
it with a dry cloth. If possibility of condensation exists, keep the device in a dry
place for at least one hour before use.
If water does get inside, remove the batteries and send the mointor to an
authorized
service center.
! Warning: Do not sterilize the monitor!
Never put the device in a disinfecting or sterilizing machine!
9. Maintenance
Verification of the pressure measurement accuracy is recommended
biannually.
BP6KT_UMEN_rev06_20210427 27
10. Disposal
This device contains an Li/MnO2 internal (non-rechargeable) battery which is
considered hazardous waste and should be disposed of accordingly. The
remainder of the device should be treated as electronic waste. Used batteries are
hazardous waste and must be disposed of accordingly.
11.2 Contraindications
a) non-cooperative patients, unconscious or otherwise incapable patients
b) patients requiring urgent/emergency cardiac care
c) patients with coagulation disturbances
BP6KT_UMEN_rev06_20210427 28
d) patients with serious mobility or other impairments without supervision
e) Devices can be applied to adult patients only. The word “adult” is used
inclusive of juvenile/adolescent patients undergoing ABPM and/or holter
ECG procedures based on well-established medical indications, if their body
dimensions (specifically upper arm circumference for ABPM and/or chest
size for ECG) are substantially equivalent with those of patients over 18
years of age, if their arm circumference falls in the range of the applicable
cuffs, and if the mental composition of such patients indicates that proper
patient cooperation can be reasonably expected.
f) though the blood pressure measurement algorithm used in the monitor has
been found to function properly on patients with atrial fibrillation or other
common arrhythmias, the oscillometric blood pressure measurement
method is generally recommended for use only with special caution on
patients with arrhythmias, Parkinson’s disease or other diseases with
tremor
Device accessories may vary based on what parts are ordered. Meditech Kft. only
supplies non-rechargeable batteries with the device.
BP6KT_UMEN_rev06_20210427 29
Technical Specifications
Technical Parameters ABPM-06
power supply 2 pcs of AA alkaline batteries or
rechargeable NiMH accumulators
(minimum 1600 mAh)
clock battery CR1620
display liquid-crystal
data storage internal solid-state memory
data transmission USB 2.0, USB A – mini USB B cable
operating environment
device temperature 10-45 °C (*)
cuff temperature 10-40 °C
humidity (non condensing) 10-85%
atmospheric pressure 70-106 kPa
storage & transportation
temperature -20 - 50 °C
humidity (non condensing) 10-95%
size 70*99*30 mm
weight 196 g
weight (with batteries) ≈ 240 g (depends on batteries)
blood pressure measurement method oscillometric
blood pressure maximum storage over 600 measurements
measurement range blood pressure: 30 - 280 mmHg (4-37
kPa); pulse: 40-240 beat/minute
passive accuracy +/- 3mmHg (0,4 kPa) or +/- 2% of
measured value (stability: 2 years)
pulse measurement accuracy measured value +/- 1%
blood pressure measurement accuracy measuring algorithm validated
according to ESH-IP, BHS and AAMI
protocols
pressure sensor piezoresistive
inflation automatically controlled pump
safety maximum inflation 300 mmHg (40
kPa), independent safety release
valve
deflation & rapid air release automatic pressure release valve
maximum number of voice memo 8 pcs of maximum 15-second-long
stored voice memos
*The conformity assessment of the device according to the MSZ EN 60601-1: 2017; MSZ EN
60601-1-6: 2010 + A1: 2015; MSZ EN 60601-1-11: 2015; MSZ EN 80601-2-30: 2011 + A1: 2015
standards was performed in a range larger than the required temperature range (up to 45 ° C).
BP6KT_UMEN_rev06_20210427 30
13. Troubleshooting
Our website can help you answer frequently asked questions about instrument
and software operation:
https://www.meditech.hu/en/q-a.html
If you cannot find the answer to your question or if you require service(s), please
submit the following form as completely filled as possible:
https://www.meditech.hu/en/troubleshooting.html
E34: cuff not on arm The cuff is attached to the device but is not
worn by the patient
device error
E90: device error The device could not measure due to a
hardware error
BP6KT_UMEN_rev06_20210427 31
E99: device error The device detects high pressure, until this
high pressure normalizes the device does
not start any further measurements
DEVICE WARRANTY. The main monitor unit will be free from defects in materials
and workmanship under normal use and service for a period of three (3) years
from the date of receipt. This warranty covers the monitor unit only. This warranty
does not cover any accessories that might come with the monitor unit.
CUFF WARRANTY. The cuff(s) - if delivered with a monitor - will be free from defects
in materials and workmanship under normal use and service for a period of one
(1) year from the date of receipt.
SERVICE WARRANTY. Meditech Kft. undertakes six (6) months warranty on the
servicing carried out.
SOFTWARE WARRANTY. The software under normal use will perform substantially
in accordance with the accompanying written/electronic documents for a period
of ninety (90) days from the date of receipt.
The warranty period begins with the delivery of the consumer product to the
consumer or, if the commissioning is carried out by the business or its agent,
begins on the day of commissioning. If the consumer puts the consumer goods
into service more than six months after delivery, the starting date of the warranty
period is the day of delivery of the consumer goods.
BP6KT_UMEN_rev06_20210427 32
use of inadequate accessories, accident, theft, or use of the monitor outside its
operating environmental specifications and intended measurement range.
Warranty conditions do not apply to putative defects that are considered to be
defects by the Partner due to inadequate knowledge or improper use of the
products. Products returned with such putative defects are subject to service
checkup charge. Removing the closing label from the back side of the monitor or
opening the unit any other way voids this warranty.
Repairs made during the warranty period will only include new parts in the
product.
If, during the first repair of a consumer product during the warranty period, it is
established by the company that the consumer product cannot be repaired, the
company shall replace the consumer product within eight days, unless otherwise
provided by the consumer. If it is not possible to replace the consumer goods, the
company is obliged to refund the purchase price to the consumer within eight
days.
If, during the warranty period, the consumer goods fail again after being repaired
three times, unless the consumer provides otherwise, and if the consumer does
not request a proportionate reduction in the purchase price and the consumer
does not wish to repair the consumer goods at the expense of the business or
repair by a third party, the business is obliged to replace the consumer product
within eight days. If it is not possible to replace the consumer goods, the company
is obliged to refund the purchase price to the consumer within eight days on the
invoice presented by the consumer and proving the payment of the consumer
goods - on the invoice or receipt issued under the VAT Act.
BP6KT_UMEN_rev06_20210427 33
If the consumer product is repaired, the warranty period will be extended from
the date of delivery for repair to the time during which the consumer was not able
to use the consumer product as intended due to the defect.
15. References
The device and the software are manufactured and developed by Meditech Kft. All
title and copyrights in and to the software, the accompanying electronic and
printed materials and any copies of the software are owned by Meditech Kft. The
software is protected by copyright laws and international treaty provisions. For
more details, please read the software license agreement.
Meditech Kft.
1184 Budapest, Mikszáth Kálmán utca 24., Hungary
Tel.: +36 1 280 8232, +36 1 280 8233
Fax: +36 1 282 9388
Mail: meditech@meditech.eu
Web: www.meditech.eu
Contact us for further product and service information. Meditech Kft. maintains a
quality assurance system certified according to ISO 9001:2015 and ISO
13485:2016.
Notified body:
CE Certiso Ltd.
2040 Budaörs, Gyár utca 2, Hungary
Tel: +36 23 880 830
http://cecertiso.hu/
This medical device complies with the specified electromagnetic emission and
electromagnetic immunity level requirements according to EN 60601-1-2:2015 (IEC
60601-1-2:2014).
This medical device may be used in places in which a patient lives or is generally
present, and in professional healthcare facility environments excluding x-ray
imaging, magnetic resonance imaging and high frequency surgical equipment
environments.
BP6KT_UMEN_rev06_20210427 34
WARNING: Use of this equipment adjacent to, or stacked with other equipment
should be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
WARNING: Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
The purchaser or user of the device must assure that the devices are used in an
appropriate electromagnetic environment as described in EN 60601-1-2:2015 (IEC
60601-1-2:2014).
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The following table contains descriptions of pictograms and other important
information about the product.
!
Always consult a physician for the interpretation of the blood pressure
measurements. Note that any blood pressure recording may be affected by
the body position, the physiological condition of the patient, and other
factors.
There are no user-serviceable parts inside the device; it contains complex
electronic and precision mechanical components. If you have any problems,
please refer the monitor to qualified service personnel. The device cannot be
modified by the user!
REF Device type (BP6 = ABPM-06)
BP6
Certification mark of the Russian Federation.
Direct current
Manufacturer
Date of production
Each device complies with the requirements of the EU Medical Devices Directive.
2409 is the identifier of the Notified Body (CE Certiso).
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MDR II According to Canadian regulations the device classification is MDR II. (Medical
Device Regulations of Canada, Rule 10.1 of MDR SOR/98-282:13Mar2007.)
Protection against environmental impact: First digit "2": Protected against mid-
IP22 sized solid objects (>12 mm). Second digit "2": Protection against vertically falling
water drops when enclosure tilted up to 15°).
SN
YYYY/nnnnnn Serial number. The first four digits of the serial number of a recorder show the year
of production. The rest is the serial number. For example: 2019/123456
This symbol shows that according to regulations the device should be handled as
electronic waste during rollout.
Indicates the acceptable upper and lower limits of relative humidity for transport
and storage, or operation. See the Technical Specifications table for further details.
Indicates the acceptable upper and lower limits of atmospheric pressure for
transport and storage, or operation. See the Technical Specifications table for
further details.
Indicates the maximum and minimum temperature limits at which the device shall
be stored, transported or used. See the Technical Specifications table for further
details.
Blood pressure measurements determined with the algorithm of an ABPM-06
monitor on adults are equivalent to those obtained by a trained observer using the
cuff/stethoscope auscultation method Korotkoff phase V, within the limits
prescribed by the American National Standard for Electronic or Automated
Sphygmomanometers. The algorithm used in ABPM-06 also fulfills the
requirements of the ESH-IP (European Society of Hypertension International
Protocol), the AAMI (Association for the Advancement of Medical Instrumentation),
and the BHS (British Hypertension Society) Validation Protocols for Automated
Blood Pressure Measuring Devices, with an A/A result in the case of BHS.
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