User Guide

ABPM-06 ambulatory blood

pressure monitor
Table of Contents

1. Product description ................................................................................................ 4

1.1 Name of parts .................................................................................................. 5
1.2 LCD display ....................................................................................................... 6
1.3 Buttons.............................................................................................................. 8
1.3.1 Start button functions ............................................................................... 9
1.3.2 Event button functions ............................................................................... 9
1.3.3 Day/night button functions ..................................................................... 10
2. How to use the monitor ....................................................................................... 10
2.1 Install the software ....................................................................................... 10
2.2 Set up the monitor ......................................................................................... 11
2.2.1 Insert 2 AA batteries into the monitor .................................................. 11
2.2.2 Connect the device to the PC ................................................................. 11
2.2.3 Communication mode ............................................................................ 11
2.3 Test the communication ............................................................................... 12
3. Program the ABPM-06.......................................................................................... 12
3.1 Program the ABPM-06 with a PC .................................................................. 12
3.2 Program the device ....................................................................................... 13
3.3 Fit the patient with the monitor ................................................................... 14
3.3.1 Control measurement ............................................................................ 14
3.4 Retrieve data .................................................................................................. 14
3.5 Customize, review & print data .................................................................... 15
3.6 ABPM-06 manual programming ................................................................... 15
3.7 The blood pressure measurement procedure ........................................... 17
3.7.1 Displaying the cuff pressure .................................................................. 18
3.7.2 Initial pressure value .............................................................................. 18
3.7.3 Storage parameters ................................................................................ 18
3.7.4 Repeating measurements ...................................................................... 18
3.7.5 SleepWell® function ............................................................................... 19
3.7.6 Clock battery ............................................................................................ 19

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.

The monitor incorporates an algorithm validated according to the ESH-IP

(European Society of Hypertension International Protocol), BHS (British
Hypertension Society) and AAMI (Association for the Advancement of Medical
Instrumentation) protocols.

ABPM-06 by Meditech is an approved, validated blood pressure monitor device for

adults, according to the STRIDE BP Scientific Advisory Board. STRIDE BP (a joint
initiative with ESH & ISH) is an international scientific non-profit organization
founded by hypertension experts with the mission of improving the accuracy of
blood pressure measurement and the diagnosis and management of
hypertension. Lists of accurate electronic devices for office, home and ambulatory
blood pressure measurement made by STRIDE BP are recommended in the 2020
International Society of Hypertension global hypertension practice guidelines.

! 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).

BP6KT_UMEN_rev06_20210427 4
1.1 Name of parts

LCD display

Start button

Event button

Day/night button

mini USB B connector

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)

the device will start the measurement

automatic blood plan is finished,
pressure measurement data
measurements is NOT yet
(clock symbol) downloaded to a
PC (clock and tick
symbol shown
simultaneously)
blood pressure event marker is set
measurement because the Event
initiated (mmHg) button is pressed

pump is in error code display

operation, building
up pressure for
measurement,
current pressure is
displayed (mmHg)
deflation during the device is
measurement, switched off, no
current pressure is automated
displayed (mmHg) measurement will
start, buttons are
inactive
systolic blood the blood pressure
pressure is measurement is
displayed after cancelled by
successful pressing a button
measurement
(mmHg)

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

battery voltage battery depletion

display (2.53 V) (crossed out
battery)
below 2.3V

PC blood pressure
communication measurement
initiated (kPa)

pump is in deflation during

operation, building measurement,
up pressure for current pressure is
measurement, displayed (kPa)
current pressure is
displayed (kPa)
systolic blood blinking heart
pressure is symbol:
displayed after measurement in
successful progress (kPa)
measurement (19.2
kPa)
diastolic blood starting voice
pressure is memo recording (3
displayed after vertical lines on the
successful left, serial number
measurement (kPa) on the right)

voice memo programming in

recording in progress: 4
progress (vertical blinking squares
lines from left to
right)

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.

1.3.2 Event button functions

The Event button may have the following 2 functions, depending on the device
configuration.

1. Setting an event marker (short press)

Pressing the button generates a "Button Press" event in the data list, which
is displayed in the evaluation software data list. Typically, this is an
indication of drug intake. One event per minute can be stored.

The patient should be informed that all events are to be recorded in the
appropriate section of the patient diary.

2. Recording a voice memo (press and hold for 5 to 10 seconds)

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

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.

1.3.3 Day/night button functions

The operation of the Day/night button depends on how the device is programmed:

1. Indicates the time of going to sleep/waking up

If the Enable manual day/night shift function is not checked (the function is
not enabled), pressing the button changes the time period (such as bedtime
and waking time) in the data list, but the frequency of automatic
measurements will not change.

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.

2. How to use the monitor

2.1 Install the software
Install either the CardioVisions or the EasyABPM software to your
PC from the supplied data carrier. If the data carrier does not
automatically start, run the start.exe program.

 CardioVisions (also suitable for research purposes)

 EasyABPM for quick and basic solutions

BP6KT_UMEN_rev06_20210427 10
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.

2.2.2 Connect the device to the PC

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!

2.2.3 Communication mode

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.

No blood pressure measurement can be initiated when the device is in

Communication mode.

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).

Look for a USB port (common symbol of a USB

port looks like this: ) on your computer.

Connect the USB cable to the PC.

Connect the device to the USB cable.

The cable is flexible, but can easily break when

cut or folded. If the cable is wrapped too
tightly or in a small arc, or if the cable is
subjected to a strong, cutting force (for
example, it gets stuck under a drawer), the
conductive wires inside may get damaged and
communication problems may occur.

2.3 Test the communication

 CardioVisions: Tools > Options > Communication, select ABPM-06 and click
Test.

 EasyABPM: Device > Read data

3. Program the ABPM-06
The device can be configured with a PC or by manual programming.

3.1 Program the ABPM-06 with a PC

 CardioVisions: Atrial fibrillation detection is not available on ABPM-06.

BP6KT_UMEN_rev06_20210427 12
3.2 Program the device
- Start programming

Programming the device erases all previous measurement data.

Therefore, it is not possible to restore previous data once the device has
been reprogrammed.

 CardioVisions (home screen): Select the model

of your device and click the Programming icon.

 EasyABPM: Device > New Examination

- Record new patient data or select a patient from the database

- Create a monitoring plan that fits in with the patient's daily routine by
providing the parameters needed for the new examination

 CardioVisions

1. The maximum available length of the plan is 51 hours in the CardioVisions

software (48 hours in EasyABPM).
2. The smallest interval between two measurements that can be set is 5
minutes.
3. The plan may include up to 400 measurements.

- Send the monitoring plan from your computer to the device

Four flashing circles at the top of the display indicate that the device is currently
being programmed.

BP6KT_UMEN_rev06_20210427 13
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.

b) Connect the tube to the monitor.

c) Place the device in the carrying case and secure

it to the patient using the waist belt/shoulder
strap.

d) Make sure your device is working properly with

a manual blood pressure measurement, or wait for the automatic control
measurement if it was enabled during programming.

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.

3.3.1 Control measurement

It is possible to perform an automatic control measurement between the time of

programming the device and the start of the measurement plan (time of
programming + 2 minutes). By performing this measurement, it is possible to
check the correct cuff placement and proper operation of the device without
having to wait too long for the first measurement of the measurement plan.

 CardioVisions: Automatic control measurement can be enabled in the

Programming window in the Blood Pressure Advanced Settings tab.

 EasyABPM: Tools > Settings > Programming > Control measurement

The device then performs the measurements according to the measurement plan.
The length of the plan is typically 24 hours, although this parameter can be
changed in the measurement plan. At the end of the plan, the data can be
downloaded to a computer.

3.4 Retrieve data

a) Remove the cuff and the device from the patient, ask for the patient's
patient diary and inquire about events, symptoms, comments, or
complaints that occurred during the measurement.

b) Start the software.

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.

 EasyABPM: Device > Read data

3.5 Customize, review & print data
a) Customize your standard report.

 CardioVisions: Tools > Options > Standard reports > ABPM report
 EasyABPM: Tools > Settings > Report
b) Review the report and edit it if necessary.

c) Create and save or print the report.

3.6 ABPM-06 manual programming

The following 3 measurement plans are available during manual programming:

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.

How to program the device manually

Press and hold the Start and Day/Night buttons

simultaneously. The measurement frequencies of the
plans are displayed after 10 seconds, each for a period
of 3 seconds. The measurement plans appear on the
display as follows: on the left, the daytime
measurement frequency, and, on the right, the
nighttime measurement frequency, which is also
indicated by the moon symbol.

To select the appropriate plan, the buttons must be

released while the selected plan is displayed. Two
beeps can be heard at this time and four flashing “o” letters appear on the top of

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.

For both PC and manual programming, successful programming of the

device is indicated by an hour icon.

IMPORTANT: The clock cannot be set during manual programming. If the

clock is inaccurate, measurements will be taken at the wrong time. If you
need to set the clock, use a PC to program the device and the clock will be
set automatically.

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.

Patient data can later be created or selected in the user software.

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

Blood pressure measurement plan parameters

The manual programming plan has the following parameters:

a) Start of measurement period: time of programming + 5 minutes

b) Length of measurement period: 24 hours
c) Beginning of daytime period: 6 hours
d) Beginning of nighttime period: 22 hours
e) Maximum pressure: 300 mmHg
f) Manual measurement frequency change: disabled
g) Starting manual measurements (by pressing the Start button): enabled
h) Measurement repetition: disabled
i) LCD display during measurement: enabled
j) Unit of measurement: mmHg

3.7 The blood pressure measurement procedure

During blood pressure measurement, the device displays the current cuff
pressure in mmHg or kPa, depending on the measurement plan. At the end of a
successful blood pressure measurement, the systolic, diastolic, and pulse values
of the blood pressure are displayed sequentially. Each value is displayed for 2
seconds before the device switches to the next. The result is displayed twice in
case of an automatic blood pressure measurement and 6 times for a manually
triggered measurement. Displaying the values can be interrupted by pressing a
button or even a new blood pressure measurement can be started.

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.

3.7.1 Displaying the cuff pressure

During blood pressure measurements, the LCD is continuously showing the

current pressure in the cuff. The device indicates that the nominal pressure range
has been exceeded by flashing the maximum value of the nominal pressure range.

The nominal pressure range of the ABPM-06 is 0 - 300 mmHg.

3.7.2 Initial pressure value

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.

3.7.3 Storage parameters

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.

3.7.4 Repeating measurements

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:

 CardioVisions: Programming > BP Settings > Enable measurement repeat

 EasyABPM: Tools > Settings > Programming > Repeat
If repeated measurements are enabled, a failed measurement will be repeated 5
minutes after the failed measurement. Measurements are repeated once.

Measurement repetition will be disabled if 5 consecutive measurements are

unsuccessful.

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.

3.7.5 SleepWell® function

The SleepWell® feature avoids long gaps between successful measurements,

while, at the same time, also helps avoiding measurements to be uncomfortably
close to each other. Therefore, the device will only repeat measurements if
measurement frequency is low and there was no successful measurement in a
long time:

1. there was no successful measurement in the last 30 minutes

2. no more than two measurements have been started in the last 30 minutes
(including manual measurements and repeated measurements)
3. the next scheduled measurement is at least 30 minutes away

Depending on the type of the software, the SleepWell® feature can be enabled in
the following ways:

 CardioVisions: Programming > BP Settings > Enable SleepWell(R)

 EasyABPM: Tools > Settings > Programming > SleepWell®
Repeated measurements must be enabled in both CardioVisions and
EasyABPM for SleepWell® to be available.

3.7.6 Clock battery

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.

• If you have coagulation disorders or treatment, report your condition to

your physician.

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.

• If you experience bloodshots, bruising, arm numbness or pain remaining

after a blood pressure measurement, the cuff should be immediately
removed, and the incident should be reported to the physician latest after
the examination.

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.

• Do not use this device in an MR environment.

• Explosive hazard: Do not use this device in an explosive atmosphere or in

the presence of flammable anesthetics or gases.

• If it is enabled during programming, you can use the Day/Night button to

manually change between the day and night periods. You can also indicate
your activity (going to sleep and waking up) by pressing the Day/Night
button.

• 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 use the device in the shower or bathtub.

• 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.

• Contact your physician for more information.

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.

5.2 Using the cuff

Wear a thin shirt or blouse under the cuff.
Wearing thin clothes under the cuff does not affect the accuracy of the
measurement, but it prevents possible problems caused by long-time wear
(sweating, itching, etc.).

Apply the cuff and make sure the „Artery” indicator is

over the brachial artery.
Place the cuff on the upper arm so that the rubber tube
points towards the patient’s shoulder and the white tissue-
sign and the “Artery” indication of the cuff is placed above
the brachial artery. Contrary to the usual placement with
the tube pointing downwards, the advantage is that the
patient can wear a loose jacket over the cuff.

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.

Connect the cuff tube to 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.

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.

The cuff is a component which, according to the relevant standards, is protected

against electrostatic discharges. Using cuffs different from those supplied by
Meditech might result in measurement error and/or, in certain cases, may cause

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.

A set of fully charged, high-capacity

batteries will enable the monitor to
make up to 250 blood pressure
measurements during a 24-hour long
monitoring session. If you use alkaline
batteries, choose high-capacity, long-
life products to enable a reliable
operation.

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.

Use standard alkaline or NiMH rechargeable batteries.

Use only standard long-life (alkaline) batteries, or standard NiMH
rechargeable batteries of the proper size. Do not use lithium batteries. Do
not mix different types of batteries, and do not mix new and old batteries.
Never use batteries of low or unknown quality, or pre-used batteries, as they may not
cover the power needs of the monitor. These may also contain acidic electrolytes which
may leak out and corrode electronic components. Never use batteries that are
damaged in any way.

Do not start a new monitoring session with low voltage batteries.

It is strongly recommended to use freshly charged accumulators or new batteries with
each examination so that batteries do not run down during monitoring, even in case of
very high blood pressure values and/or a long monitoring session. After inserting
batteries into the device, it is advised to check their voltage before programming. The
typical voltage for fully charged rechargeable batteries should be over 2.5V and for
fresh alkaline batteries, over 3V.
Battery voltage check: Press and hold the Start button for 5 to 10 seconds.

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.

Remove the batteries if the monitor is not in use.

If you do not use the device, it is advisable to remove the batteries since they may run
down due to the small, but constant power consumption of the integrated circuits of
the device. Data in the monitor is not lost even if batteries run down or are removed.

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.

See the Cuffs chapter for more information.

8. Cleaning & protection

ABPM-06 is IP22 protected.

Cleaning the monitor

A recommended means of cleaning is to wipe
the monitor with a disinfectant cleaning
tissue. Alternatively, wipe with a slightly
damp cloth then dry it with an antistatic
tissue. Do not expose the monitor to
extreme heat, including long exposure to
direct strong sunlight.

Cleaning the textile cuffs

To clean the textile cuff please do the following:
a) Remove the bladder.
b) Wash by hand the sleeve with lukewarm water and regular washing liquid
suitable for black material. Rinse well.
c) If required, wipe the bladder with a soft cleaning tissue.
d) Allow both the bladder and sleeve to air dry.
e) Put the bladder back in the sleeve: place the sleeve with its pocket-side up
and place the bladder in a way so that where the tube connects into the
bladder is in the upper left corner. Pull the tube through the hole in the
sleeve. Slide the integrated bladder into the pocket, if needed, by pulling the
rubber tube through the hole designated for it. Slide the bladder all the way
in, until it disappears in the sleeve. Finally, make sure the bladder smoothly
fits (no creases, no folds on the bladder).

Cleaning the PU leather fabric cuff

Wipe the sleeve with a damped cloth or detergent/disinfectant tissue (for example,
ethanol 70%, isopropyl-alcohol 70%, Microzid). Please note that the bladder
cannot be removed.

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.

The device is covered by a two-year warranty under the general warranty

conditions of Meditech Kft., for details, see the relevant chapter. This warranty
does not cover any malfunctions or defects resulting from improper use, or the
use of inadequate accessories, accident, theft, or use of the device outside its
operating environmental specifications or intended measurement range.
Removing the label from the back side of the device voids this warranty.

! Warning: The maintenance and repair of this equipment should only be

performed by qualified and Meditech-approved personnel!

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 user bears full
responsibility for any consequences of improper intervention. For service
information, please contact your distributor or Meditech Kft. The documentation
and expertise required for the repair can be found at the manufacturer, Meditech
Kft., and at the distributor companies.

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. Indications & contraindications

11.1 Indications for ambulatory blood pressure monitoring
The list of clinical indications is based on the 2018 ESC/ESH Guidelines for the
management of arterial hypertension:

a) Conditions in which white-coat hypertension is more common, for example:

i. Grade I hypertension on office blood pressure measurement
ii. Marked office blood pressure elevation without hypertension-mediated
organ damage (HMOD)
b) Conditions in which masked hypertension is more common, for example:
i. High-normal office blood pressure
ii. Normal office blood pressure in individuals with HMOD or at high total
cardiovascular (CV) risk
c) Postural and post-prandial hypotension in untreated and treated patients
d) Evaluation of resistant hypertension
e) Evaluation of blood pressure control, especially in treated higher-risk
patients
f) Exaggerated blood pressure response to exercise
g) When there is considerable variability in the office blood pressure
h) Evaluating symptoms consistent with hypotension during treatment
i) Specific indications for ABPM rather than HBPM:
i. Assessment of nocturnal blood pressure values and dipping status (for
example, suspicion of nocturnal hypertension, such as in sleep apnea,
chronic kidney disease (CKD), diabetes, endocrine hypertension, or
autonomic dysfunction)

These recommendations are in accordance with the the 2017

ACC/AHA/AAPA/ABC/ACPM/ AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the
Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults
as well.

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

12. List of possible accessories

Name Type/ID Note

ABPM-06
Pouch Pouch pouch for the recorder
with shoulder and waist
straps
Cuff normal BP4-A010-MED -
USB interface cable Standard USB A – mini USB B cable -
User Manual (EN) BP6KT_UMEN_revXX Data carrier and printed
version
Alkaline battery Standard, commercial Minimum 1600 mAh,
AA 2 pcs
Patient diary (HU/EN) BP5_BP6KT_patient_diary_revXXHU Data carrier and printed
BP5_BP6KT_patient_diary_revXXEN version
Information for Patients BP5BP6USER_HU_VXX Leaflet
BP5BP6USER_EN_VXX
Data carrier USB pendrive

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

13.1 Error codes

During operation, malfunctions may occur, which are indicated by an 'E' and a
number on the display. Also, a 4x4 beep alerts the user that something has gone
wrong. The error codes remain on the display for 10 seconds - or until user
intervention - and then disappear. Depending on the nature of the error, the
device stores the generated error codes, which can be analyzed later by the user
software.
Error code Explanation
measurement error
E1: aborted measurement The measurement is aborted due to
timeout (the patient was moving)

E2: measurement interrupted manually The measurement was stopped by

E3: batteries discharged
E8: pressure limit exceeded
cuff error
E31: cuff missing or loose
E32: cuff tubing clogged
E33: cuff leaking or loose
pressing a button or a button was being
pressed continuously so automatic
measurement was not started
The measurement was interrupted due to
the weakness of the battery
The device should have pumped above the
allowable pressure limit to measure blood
pressure
There was no cuff connected to the device
or the cuff was too loose on the patient's
arm
The cuff is clogged or the rubber tube is
broken
The cuff or the device is leaking

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

14. Meditech product warranty information

Based on the Directive 1999/44/EC of the European Parliament and of the Council
of 25 May 1999 on certain aspects of the sale of consumer goods and associated
guarantees Meditech Kft. undertakes the warranty of its products as follows:

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.

ACCESSORIES WARRANTY. The non-disposable accessories delivered with the

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. This warranty
does not cover disposable accessories, packaging materials, accumulators and
batteries, cuffs, or any of their components.

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.

This warranty is valid at the representative address of Meditech Kft. unless

otherwise displayed upon a commercial invoice or any other valid business
document duly signed by the supplier and the recipient of the Meditech product.
If such business document displaying a certain site for warranty validity cannot be
presented, this warranty is valid at Meditech HQ office in Budapest, Hungary. The
rights arising from the warranty can be claimed by the owner of the consumer
product with the warranty card. This warranty does not cover any malfunction or
defects of the monitor unit or any of its accessories arising from improper use, the

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.

EXCLUSION OF BIOHAZARD. Meditech will not accept for repair potentially

infectious products or accessories, especially pouches and cuffs that might have
been in direct contact with the patient, and could not be, or (potentially) were not,
properly disinfected, even within the warranty period. If a problem occurs within
the warranty period, such accessories will be replaced without any physical
inspection, reserving the rights to hold an inspection when found necessary.

NO OTHER WARRANTIES. Meditech disclaims all other warranties, either

expressed or implied, including, but not limited to, implied warranties of
merchantability and fitness for a particular purpose, with regard to the monitor,
any accessory or other accompanying hardware, and the software.

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.

If the consumer claims a replacement within three working days of purchase

(commissioning) due to a defect in the consumer product, the business is obliged
to replace the consumer product, provided that the defect prevents the intended
use.

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/

16. EMC information

Medical electrical equipment should be used with precautions according to EMC
(electromagnetic compatibility), and must be installed according to the EMC
notices disclosed in this manual, otherwise the fulfillment of the requirements for
electromagnetic emission and electromagnetic immunity may be adversely
affected.

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: Portable RF communications equipment (including peripherals such

as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the ABPM-06 device, including cables. Otherwise,
degradation in the performance of this equipment may be expected.

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).

The information in this document is subject to change without notice. Please

read the related electronic user manuals available on the accompanying
data carrier!

BP6KT_UMEN_rev06_20210427 35
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

Read the user manual before using the device.

This signal directs attention to the description of that part.

Manufacturer

Date of production

Device confirms to the standards of USB (Universal Serial Bus)

Each device complies with the requirements of the EU Medical Devices Directive.
2409 is the identifier of the Notified Body (CE Certiso).

MDD IIa MDD classification IIa. EMC class B. EMC group 1.

BP6KT_UMEN_rev06_20210427 36
 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.)

The monitor is an internally powered type CF device. Protection vs. ingress of

water: none. Mode of operation: continuous. The device is not protected against
defibrillators or other high frequency surgical equipment.

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.

BP6KT_UMEN_rev06_20210427 37