User Guide

ABPM-04 ambulatory blood pressure

monitor
card(X)plore combined device
Table of Contents

1 Product Description ............................................................................................................. 3

1.1 Name of parts ............................................................................................................. 4
1.2 LCD display ................................................................................................................. 5
1.3 Buttons ........................................................................................................................ 7
2 How to Use the Monitor ...................................................................................................... 8
2.1 Install the software..................................................................................................... 8
2.2 Setup the monitor ...................................................................................................... 9
2.3 Test communication ................................................................................................ 10
2.4 Program the monitor ............................................................................................... 10
2.5 Fit the patient with the monitor .............................................................................. 11
2.6 Retrieve data ............................................................................................................. 11
2.7 Customize, review & print data ............................................................................... 12
3 Patient Information ............................................................................................................ 12
4 Cuffs .................................................................................................................................... 14
4.1 Dimensions ............................................................................................................... 14
4.2 Application ................................................................................................................ 15
5 ECG Patient Cable............................................................................................................... 16
5.1 Electrode placement ................................................................................................ 16
6 Memory Card ...................................................................................................................... 19
7 Batteries .............................................................................................................................. 20
8 Safety Concerns .................................................................................................................. 21
9 Cleaning & Protection ........................................................................................................ 22
10 Maintenance ....................................................................................................................... 23
11 Disposal............................................................................................................................... 23
12 Intended Use, Indications, Contraindications .................................................................. 24
13 Possible Accessories list..................................................................................................... 27
14 Technical Specifications ..................................................................................................... 28
15 Troubleshooting ................................................................................................................. 29
15.1 Error codes................................................................................................................ 29
16 Meditech product warranty information ......................................................................... 30
17 References .......................................................................................................................... 32
18 EMC information ................................................................................................................ 34

BP4CT2KT_UMEN_V06_20211005 2
1 Product Description
ABPM-04 ambulatory blood pressure monitor

ABPM-04 provides accurate information on blood pressure variability, overnight

dipping and morning surge for reliable hypertension control.

ABPM-04 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.

card(X)plore ambulatory blood pressure, Holter ECG & actigraphy monitor

Card(X)plore (CT2) is a combined ambulatory blood pressure and 3 channel Holter

ECG recorder. The intended use is to gather the blood pressure and ECG strips values
for a 24 hour or longer monitoring period while the patient does everything as they
would do as part of their daily routine. During the monitoring period patients can
mark the exact time of any indisposition or other event related to their health status.
The accessories (standard ECG electrodes) used in our system are standardized ones,
and widely used for these purposes. The device is not intended to be used to direct
cardiac contact, in operating theatre, same time and place with high frequency
surgical equipment or defibrillator, and in hazardous environment because of
flammable anesthetic mixtures or possibility of ingress of water.

Enabling actigraphy-the two-axis motion detection function- is optional, activity and

body position monitoring provide additional data to help fine-tune the results. It has
no direct clinical significance in general clinical practice and is specifically
recommended for research purposes.

IMPORTANT: The device can be applied to adult patients only! (See the
Contraindications chapter for more details)

BP4CT2KT_UMEN_V06_20211005 3
 1.1 Name of parts

start button

event button
LCD display

cuff connector
ECG cable connector socket
socket
(card(X)plore only)

battery compartment

sticker with the serial number

memory card slot

(card(X)plore only)

interface connection

BP4CT2KT_UMEN_V06_20211005 4
1.2 LCD display
ABPM-04 monitor

Normal status: time Pulse rate value of

is displayed a just completed
measurement
(beats/minute)
Blood pressure Event marker set
measurement due to pressing the
initiated (mmHg) Event button
Pumping for Error code display
measurement,
current pressure is
displayed (mmHg)

Deflation during The device is

measurement, switched off
current pressure is
displayed (mmHg)
Systolic value of a The blood pressure
just completed measurement is
measurement cancelled by
(mmHg) pressing a button
Diastolic value of a Rectangle blinking
just completed in sync with pulse:
measurement measurement in
(mmHg) progress (mmHg)

battery voltage Communication

display (5.37V) with a personal
computer
LCD check: all Low battery voltage
segments are (three dots below)
displayed

BP4CT2KT_UMEN_V06_20211005 5
card(X)plore monitor

LCD check: all Normal status: time

segments are is displayed
displayed
Communication Blood pressure
with a PC measurement
initiated (mmHg)

Pumping for blood The blood pressure

pressure measurement is
measurement cancelled by
(current pressure in pressing a button
mmHg)
Systolic value of a Diastolic value of a
just completed just completed
measurement measurement
(mmHg) (mmHg)

Pulse rate value of a Battery voltage

just completed display (5.37V)
measurement
(beats/minute)
Low battery (3 dots Monitoring plan is
at the bottom) completed

The monitoring Blinking display:

plan is not running: monitoring plan
plan not started or activation in
memory card progress
missing/removed
Leads off,
electrodes have
fallen off (all
channels have
fallen off in the
figure, the affected
channels are shown
by the lines on the
right)

BP4CT2KT_UMEN_V06_20211005 6
1.3 Buttons
The monitors have two buttons: the Start and the Event buttons. Any ongoing
blood pressure measurement can be interrupted by pressing any button at any
time. This will result in immediate fast cuff deflation. card(X)plore has no on/off
switch or button. The monitor carries out the measurements according to the
preset program.

start button
- start a manual BP measurement
- switch on/off (ABPM-04 only)
- LCD check
- battery voltage check

event button
- set an event marker
- switch between the
active/passive period (card(x)plore
only)

ABPM-04 monitor

Start button functions

a) starts a manual blood pressure measurement (press shortly)
Whenever necessary, the patient may initiate an unplanned blood pressure
measurement. Typical causes for this use: dizziness, pain (angina pectoris
or headache), palpitation.
b) switches the device off (press and hold for more than 10 seconds)
Press and hold the Start button until 2 horizontal segments appear on the
LCD ( - - ).
c) switches the device on (press and hold for more than 3 seconds when the
device is turned off)
d) checks the LCD functions (press and hold for less than 5 seconds)
Press and hold to check that all segments of the LCD appeared.
e) checks battery voltage (press and hold for more than 5 seconds but less
than 10 seconds)
The voltage for fully charged accumulators should be over 5.1V, or over 6.1V
if you use alkaline batteries.

BP4CT2KT_UMEN_V06_20211005 7
Event button functions
a) sets a patient event marker (press shortly)
Typical cause for this use is taking medicine. The patient should be
instructed to record the reason for setting an event marker in the patient
diary.

card(X)plore monitor

Start button functions

a) starts a manual blood pressure measurement
Whenever necessary, the patient may initiate an unplanned blood pressure
measurement. Typical causes for this use: dizziness, pain (angina pectoris
or headache), palpitation.
b) checks the LCD functions (press and hold for less than 5 seconds)
Press and hold to check that all segments of the LCD appeared.
c) checks battery voltage (press and hold for more than 5 seconds but less
than 10 seconds)
The voltage for fully charged accumulators should be over 5.1V, or over 6.1V
if you use alkaline batteries.

Event button functions

a) sets a patient event marker (press shortly)
Typical cause for this use is taking medicine. The patient should be
instructed to record the reason for setting an event marker in the patient
diary.
b) switches between active and passive periods (press and hold for more than
5 seconds)
If the Enable manual day/night shift function is enabled and set up during
programming the monitor, the patient can manually change between the
set measurement frequency periods (for example, day or night).

2 How to Use the Monitor

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

 CardioVisions: for ABPM-04, card(X)plore (best for research purposes)

 EasyABPM: for ABPM-04 (best for quick and basic solutions)
BP4CT2KT_UMEN_V06_20211005 8
2.2 Setup the monitor
a) Install 4 AA batteries into the monitor

Voltage should be over 5.1V in case of freshly charged accumulators and

over 6.1V if alkaline batteries are used. Check battery voltage by pressing
the Start button for at least 5 seconds.

b) Install the memory card into the monitor (card(X)plore only)

c) Setup communication between the device and the PC

A special USB optical cable connects the monitor to the PC. Always install
the software before connecting the USB optical cable to the PC! (The USB
driver is installed together with the software, in the absence of which the PC
will not recognize the interface.)

Locate a USB port (often labelled )

or a free 9-pin serial port (also called
RS232) on your computer.

If you have a USB port on your

computer, then connect the USB-type
optoelectronic interface from
Meditech. If you have a serial RS232
port on your computer, plug in the OI3
or any newer serial optoelectronic
interface. If you have a USB port on
your computer but you have a serial
optoelectronic interface, use a USB-to-
serial converter.

Take the optoelectronic interface unit with the optical cable out of the
package.

Connect the interface unit to the port.

BP4CT2KT_UMEN_V06_20211005 9
 Connect the recorder to the optical cable.

The interface unit converts optical signals to electric signals and back. The twin
optical cable transfers optical signals between the interface unit and the recorder.
The cable is flexible, but it is sensitive to overfolding and to cutting forces. If you
fold the optical cable in too small a radius, or if a strong cutting force (for example,
by the edge of a drawer) is applied to it, the optical cable may become optically
distorted, which might result in communication errors.

2.3 Test communication

 CardioVisions: click Tools > Options >

Communication, select your device from
the dropdown list, select the type of your
interface unit, and select the required port or
simply click Test.

 EasyABPM: Device > Read data

2.4 Program the monitor
For more information on using the software, see the CardioVisions and
EasyABPM user manuals.

a) Start programming

 CardioVisions (Home screen): select your

device type and click Programming...

 EasyABPM: Device > New examination

b) Enter new patient data or select a patient from the database.
c) Create a monitoring plan adjusted to the patient’s daily routine by filling out
the parameters for the new study.

BP4CT2KT_UMEN_V06_20211005 10
 d) Send the monitoring plan from the computer to the recorder unit.

2.5 Fit the patient with the monitor

a) Apply a proper-size cuff to the patient’s non-dominant
arm and be sure that the artery indicator is over the
brachial artery.
b) Connect the hose to the monitor.
c) card(X)plore only: connect the ECG cable to the
monitor, attach disposable electrodes to the cable and
apply the electrodes to the patient by using pull-relief
loops (strongly recommended) on lead cables. Correct
electrode-placement can be checked in the software if
you connect the monitor to the PC.

For more information on electrode placement, see

the ECG patient cable chapter.

d) Place the monitor in the pouch and affix the patient with the belt.
e) Start a manual blood pressure measurement to verify if the monitor is
working properly.
f) Provide a patient diary for the patient (a sample is available on the data
carrier) and inform the patient about the purpose and the expected results
of the monitoring and about the use of the monitor.

2.6 Retrieve data

a) Remove the monitor and the accessories
from the returned patient and ask for the
patient diary for any events, symptoms,
observations or complaints.
b) Start the software.
c) Establish communication between the monitor and the PC.

 CardioVisions: select your monitor from the dropdown list.

BP4CT2KT_UMEN_V06_20211005 11
 i. card(X)plore: remove the memory card from the monitor and insert
it into the card reader unit of your PC.
ii. ABPM-04: connect the monitor to your PC with your optical cable.
d) read data.

 EasyABPM: Device > Read data

Calculation of major parameters in the software

Heart Rate (HR): HR = 60/RRavr. The average RR distance (RRavr) is calculated every 30 seconds.

Pause: pause is identified by a more than 2.5-second distance between two adjacent beats.

ST: J-point and baseline, which can be found around the inflection point between P and Q, are the
basis for ST calculation. Average ST is calculated every 30 seconds to each channel. ST event starts
if 2 consecutive 30-second ST averages are pathological, and ends if 2 consecutive 30-second ST
averages are not pathological. ST pathological limits are user-definable. Default limit values are: ST
depression: -0.1 mV; ST elevation: +0.2 mV.

2.7 Customize, review & print data

a) Customize your standard report

 CardioVisions: Tools > Options > Standard reports

 EasyABPM: Tools > Settings > Report
b) Review the study and, if necessary, edit data.
c) Create and save or print the report.

3 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.
• Modification of the device is not allowed. Never disconnect any accessory
from the device, never remove the memory card from card(X)plore. During
the examination report any problem or battery run down to your physician.
• Never (re)place the cuff or the electrodes 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

BP4CT2KT_UMEN_V06_20211005 12
 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, or the electrodes 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.
• Should an electrode fall off, it should be reapplied to the same place as soon
as possible card(X)plore indicates fallen electrodes by displaying “EE” on the
LCD followed by a horizontal line or lines.
• Never measure anybody else’s blood pressure or ECG 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 or any cables or tubes 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 blood pressure 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.
• If you feel dizziness, angina pectoris, palpitation, or headache, press the
unmarked Start button shortly to start a manual blood pressure
measurement.
• Press the Event button marked with a circle shortly to make a note of an
event (for example, taking medication). Such events should be recorded in
the patient diary as well.

BP4CT2KT_UMEN_V06_20211005 13
 • card(X)plore only: If it is enabled during programming, you can use the Event
button to manually change between the day and night periods (press and
hold for more than 5 seconds).

• Do not wear synthetic clothes during an ECG examination.

• 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.
• As long as only one patient cable or electrode is in contact with the skin,
electrodes that are still (or already) exposed must not touch a conductive
surface or any surface with which a contact may result in an electric shock,
as a possible electric shock through the connected electrode(s) can be life-
threatening.
• 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, take off the device, remove the batteries, and return
the device to your physician.
• Contact your physician for more information.

4 Cuffs
4.1 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

BP4CT2KT_UMEN_V06_20211005 14
If the patient’s arm circumference range is out of the ranges indicated above, use
the cuff which best fits the patient and make a so-called undercuffing or
overcuffing calculation.

Set the size of the cuff during programming the device.

The monitors recognize three different cuff sizes. The size to
be used should be set during the programming of the device.
Inappropriate setting of the cuff size may lead to device
malfunctioning, which is inconvenient for the patient and may
lead to an unsuccessful measurement.

4.2 Application
Wear a thin shirt or blouse under the cuff.
It is advisable to wear a thin shirt or blouse under the cuff, because it prevents
possible problems caused by long-time wear (sweating, itching, etc.).

Apply the cuff and be 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 ’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.

When properly applied, the end of the sleeve (the one

closer to the tube) should fall in the indicated range.

Connect the hose to the monitor.

Connect the air connector of the cuff into the air connector socket of the device by
turning it clockwise with a slight pressure.

BP4CT2KT_UMEN_V06_20211005 15
 Take care to avoid blocking the air flow in the tube of the cuff or 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 simultaneously used monitoring medical equipment 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 comfortable for the patient. A too loose
application may result in longer or aborted measurements, because the device
has to pump just to reach the proper tightness. Longer measurements may cause
inconvenience for the patient, and aborted measurements result in less data for
evaluation. If the patient removes the cuff for a period during the monitoring
session, it should be reapplied with appropriate tightness, with help from another
person, if necessary.

The cuff is the component which, by definition of the relevant standard, is

protected against a defibrillator discharge. Using a cuff different from that
supplied by Meditech might result in measurement error and/or in certain cases
it may cause damage to the main recorder unit.

5 ECG Patient Cable

For card(X)plore only

The electrodes should be properly placed on and

connected. Good electrode contact requires skin
preparation and electrodes designed for long-term
application.

5.1 Electrode placement

1. Clean and possibly depilate the chest
Electrodes should be fixed onto a thoroughly
cleaned and, if necessary, depilated skin to ensure
a reliable and stable contact. Wearing synthetic
clothes will cause static disturbances, adding noise
to the ECG. Advise your patient not to wear such
clothes during monitoring.

BP4CT2KT_UMEN_V06_20211005 16
2. Connect the ECG patient cable to its socket on the recorder
The multi-lead ECG patient cable can be connected into the socket on the top of
the device by a standard plug. Align the plug and socket marks, push and turn
gently clockwise. Turn counterclockwise to disconnect. Make sure that the pin
number matches the socket type.

3. Attach the disposable electrodes to the ECG lead cable connectors

Always do this procedure prior to attaching the electrodes to the patient’s chest.
Attaching the ECG cable connectors to the electrodes after placing them on the
patient’s chest may cause inconvenience or even pain.

4. Remove electrode protection films

5. Apply the electrodes to the proper positions

Meditech card(X)plore uses a 7-lead cable to record three channels, where each
ECG channel is defined as the difference between a pair of electrodes, with one
neutral electrode used for feedback. Multi-channel recording improves the chance
to avoid misdiagnosed recordings, reduces the chance to miss something
important due to noise, electrode problems or improper “viewing angle”.

See the standard ECG cable color codes and recommended positions in the
following table.

Electrode Color Recommended position

A+ red left anterior axillary line, intercostal

space 5
A- white manubrium sterni
B+ brown left anterior axillary line, intercostal
space 5
B- black right anterior axillary line,
intercostal space 5
C+ orange left posterior axillary line,
intercostal space 5
C- blue right sternal border, rib 2
N green corpus sterni

In the recommended layout, described in the table above and shown in the figure,
the resulting channels will correspond to the most used ambulatory ECG leads as
follows:
channel A = CM5
channel B = CC5
channel C = inverse Nehb J

BP4CT2KT_UMEN_V06_20211005 17
6. Create stress-release loops with each cable
It is strongly recommended to create a stress-release cable loop on each lead
cable, close to the electrode (about 5-10 cm) and fix it to the patient’s skin with
non-allergic adhesive tape. This significantly reduces possible technical problems
with ECG signals. Loop-protected cables will reduce movement disturbances.

7. Check the electrode placement online

It is highly recommended to check electrode placement before an ECG recording
session to record the best quality ECG signals. The CardioVisions software
provides online ECG monitoring capability to check electrode placement. Attach
the electrodes to the patient, connect the ECG patient cable to the recorder, and
connect the recorder to the PC to use this function. The following details can be
highlighted by online electrode checking:

a) Is galvanic contact established (do you have ECG curves)?

b) Is the placement of electrodes correct to gain leads as intended?
c) Are ECG signals clear, with proper polarity and sufficient gain?
d) Does breathing or other muscle movement not disturb ECG signals?
e) What are the initial ST levels and heart rate?

The on-line ECG monitoring screen will display a moving average ECG cycle in
addition to running curves. It will calculate and display heart rate, ST values
(depression or elevation from baseline) and a slope value. These values are
analyzed on all leads. The ST elevation and slope are displayed in the report. Heart
rate and the QRS complex parameters are calculated from a 30-second average.
You can use these values to determine initial heart rate and ST levels and adjust
trigger limits accordingly when you create your monitoring plan. Wrong
adjustment of the trigger limits may result in inconvenient, disturbing operation
of the device, which may reduce the patient's ability to cooperate and therefore it
may decrease the appropriate evaluation of the measurements.

Electrodes (and patient lead cables) should in all cases be applied to a

patient in a minimum safety distance of 2 meters from any electric devices,
metallic objects or other electric conductors. As long as any patient lead
cables (with electrodes) are applied to the patient, not yet applied or
disconnected lead cables must not contact potential electric shock hazard sources or
electric conductors, as such contact may, through still applied electrodes, serve as a
pathway for a potentially life-threatening electric shock. Synthetic clothes should be
avoided to reduce static discharge related noise. Use of pull-relief loops on lead cables
and fixing them with adhesive tape is strongly recommended.

BP4CT2KT_UMEN_V06_20211005 18
6 Memory Card
card(X)plore only!

card(X)plore uses SD or MMC flash memory cards to record data. Fully insert the
Meditech supplied memory card into the recorder.

All data stored on the card will be erased during programming. Please note that
Meditech assumes no responsibility for the loss or destruction of such data. You
will need a USB 2.0 card reader unit built into or connected to your computer to
transfer the recorded data to your database after a monitoring session.

It is highly recommended to use a card exclusively for monitoring with one

device; using the same card for other purposes may result in data loss,
malfunction, or a failed monitoring session.

Never remove the card or remove the batteries from a card-based recorder
while accessing the card (i.e., during storage, deletion or initialization operations), since
data stored in the card may be destroyed. Remove the card from a recorder only if the
monitoring session is completed. If you use a card from another source, or need to re-
format the card supplied, note that according to Microsoft recommendations the card
should be formatted to a FAT16 file system to work properly with Windows systems.

Meditech monitors will work with FAT32-formatted cards, but you may experience data
access problems with cards formatted so on your computer.

The memory card is a precision electronic device. Place it in antistatic case when
carrying and storing it. Failure to do so may result in damage to the card caused by
static electricity. Do not apply strong force or impact to the card, nor bend or drop it.
Do not put the card in the pocket of your pants, etc. Do not use or store the card in an
environment with possibly strong static electricity/electric noise, including the
immediate proximity of mobile phones. Do not use or store the card in a high
temperature or highly humid environment, nor subject it to a corrosive environment.
Protect the contacts from dirt and particles that may come in contact with, or adhere
to the card. Use only dry, soft cloth to wipe away dirt. Keep the card out of the reach of
children to prevent accidental ingestion. If the card is swallowed, seek medical
assistance immediately.

The lifetime of the card is limited because it uses flash memory. It will not be able to
save data after it has been used for a period exceeding its lifetime. In this case, replace
the card with a new one.

Please note that as a security measure, parcels during the transportation might be
subjected to high levels of radiation. High level radiation erases all data stored on an
SD card and renders the card useless. Please check and verify postal service policies
before sending memory cards by mail.

BP4CT2KT_UMEN_V06_20211005 19
7 Batteries
The monitors operate with four 1.5V AA batteries or four 1.2V AA rechargeable
batteries.

A set of properly charged, high capacity batteries will enable the monitors to
perform 250 blood pressure measurements during a 24-48-hour long monitoring
session. If you use alkaline batteries, choose high capacity, long-life products for
reliable operation.

In order to change batteries, take the recorder out of the holder pouch and
remove the battery compartment cover on the backside. Place four properly
charged, high capacity AA rechargeable, or four 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 battery types; 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 recorder, and they may damage the recorder, or they may contain
acidic electrolytes which may leak and corrode electronic components. Never use
batteries damaged in any way.

Do not start a new monitoring session with low batteries.

It is strongly recommended to use freshly charged accumulators or new batteries with
each patient 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 Meditech ambulatory blood pressure monitors, it is advised to check their voltage
before programming. The typical voltage for fully charged rechargeable batteries
should be over 5.1V and for fresh alkaline batteries, over 6.1V.
Battery voltage check: Press the Start button for at least 5 seconds.

If measurements do not start in due time keep fresh batteries in the recorder.
If a recorder is not used for a long period, the built-in backup cell, ensuring the
operation of the internal clock, may get discharged. In this case keep freshly charged
batteries in the recorder for at least one day; this will recharge the backup cell. It is
possible to use the recorder afterwards. If the backup cell is not properly charged, the
internal clock may work incorrectly, and the recorder may not start measurements in

BP4CT2KT_UMEN_V06_20211005 20
due time. If the recharging of the cell is not successful, the backup cell must be changed
by the service personnel. This is an out of warranty act.

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 recorder is out of use.

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

8 Safety Concerns
Electric shock hazard protection
Meditech monitors meet the relevant shock hazard protection standards. The
devices operate with four 1.5V AA batteries or four 1.2V AA rechargeable batteries,
which exclude all electric shock hazards, even in the unlikely case of multiple
device errors.

Keep a safety distance of at least 2 meters from any electric devices, metallic
objects or other electric conductors during application and removal of ECG
electrodes. As long as any patient lead cables (with electrodes) are applied to the
patient, not yet applied or disconnected lead cables must not contact potential
shock hazard sources or electric conductors as such contact may, through applied
electrodes, serve as a pathway for a potentially life-threatening electric shock.

Many personal computers do not meet shock hazard protection standards or strict
safety regulations applicable to medical devices. Therefore, during the computer-
based use of Meditech recorders, keep at least a 2-meter distance between the
patient and the computer. This is the required minimum safety distance. Meditech
monitors communicate via a plastic optical cable, the 3-meter standard length (can
be extended to 10 meters) of which allows for the required safety distance. The
plastic optical cable ensures perfect electric separation and reduces the effects of
external electric noise. The optical cable does not conduct electricity.

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.
Use only high-quality ECG lead cables and disposable electrodes. Use only
biocompatible adhesive tape to fix lead cables in pull-relief loops.

BP4CT2KT_UMEN_V06_20211005 21
Hazardous materials
Used batteries qualify as hazardous waste and should be disposed with care.
Meditech recorders do not contain any materials qualified as pharmaceutical
substance or tissue of animal origin. They emit no material hazardous to humans.

Risk of incorrect diagnosis

The basic intended use of Meditech monitors is to record blood pressure and
pulse rate values (ABPM-04) in addition with Holter ECG with activity (card(X)plore).

Recorded ECG quality depends mainly on the quality of the electrode contact and
recording conditions, so valuable recordings are to be expected from properly
instructed cooperative patients, using properly applied, high quality electrodes.
Patients should be informed about rules of cooperative behavior; proper handling
of the monitor, and the expected results of monitoring in advance.
The recorders only provide data to support diagnostic decisions of a qualified
physician; they do not automatically provide a diagnosis of any kind. During the
evaluation of recorded blood pressure values, possible artefacts due to external
disturbances, motion artefacts, and electrical noise should be observed and
handled with caution.

See chapters Cuffs, ECG patient Cable and memory Card for more information!

9 Cleaning & Protection

ABPM-04 and card(X)plore devices are rated IP22,
however, this level of protection is achieved ONLY if the
monitor is placed into its pouch.

Cleaning the monitor

A recommended means of cleaning is to wipe the
recorder with a disinfectant cleaning tissue (for example,
with Henkel Ecolab Incides, and similar products).
Alternatively, wipe with a slightly damp cloth then dry it
with an antistatic tissue. Do not expose recorders to
extreme heat or radiation, including long exposure to
direct strong sunlight.

Cleaning the cuffs

To clean the PU leather fabric cuff, please do the following:

Wipe the outer part of the cuff with a cloth damped by water or detergent
disinfectant (for example, ethanol 70%, isopropyl-alcohol 70%, microzid). The
inner side of the cuff cannot be removed!

BP4CT2KT_UMEN_V06_20211005 22
 Avoid any leakage into the tube while cleaning the cuff. (Plug the end of the
tube.) Don’t take the unit into a sterilizing machine! Don’t use bleach!

Protection
Do not immerse the recorder 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, such as shower, bath or swimming pool. In case of minor
effects of wet environment, wipe off water drops with a dry cloth. Keep the
recorder in a normal dry room for at least one hour before use if condensation is
suspected.

In case of ingress of water in the recorder, remove batteries from the unit, and
refer the unit to an authorized service center.

Never place a recorder unit in a disinfecting or sterilizing machine!

10 Maintenance
Verification of the pressure measurement accuracy is recommended
biannually. Check ECG accuracy yearly by using a known ECG signal source.

All the devices are covered by warranty 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, see chapter 16
Meditech product warranty information. This warranty does not cover any
malfunction or defects arising from improper use, the use of inadequate
accessories, accident, theft, or use of the device outside operating environmental
specifications or intended measurement range. Removing the closing label from
the back side of the device voids this warranty.

There are no user serviceable parts inside Meditech monitors; they contain
high complexity electronic and fine mechanical components. If you have any
problems, please refer the recorder to qualified service personnel. All
consequences of improper servicing are the sole responsibility of the user. Contact
Meditech or your distributor for more service information. Documentation and
service know-how are available at Meditech and the distributor entities as well.

11 Disposal
The device should be handled as normal electronic waste at roll-out. Used
batteries may also fall under the category of hazardous waste and should be
disposed with proper care.

BP4CT2KT_UMEN_V06_20211005 23
12 Intended Use, Indications, Contraindications
Intended use
ABPM-04 is an active medical device, a non-invasive oscillometric ambulatory
blood pressure monitor that is intended to be used with dedicated PC-based
computer program for the recording and displaying of systolic and diastolic blood
pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and
treatment when it is necessary to measure an adult patient’s systolic and diastolic
blood pressures over an extended period of time. The system is only for
measurement, recording, and display (bedside monitoring or intensive care
monitoring excluded) to assist a licensed physician in making a diagnosis.

The card(X)plore is a combined, non-invasive oscillometric ambulatory blood

pressure monitor (as such, the information regarding the intended use of ABPM-
04 is valid for card(X)plore in its entirety) and a full disclosure ECG recording
(Holter) device.

The intended use of card(X)plore as a full disclosure ECG recording (Holter) device
is to gather the ECG measurements for up to a 51-hour period while the patient
does everything as he/she does it in his/her daily routine.

The device is intended for use as an aid or adjunct to diagnosis and treatment
when it is necessary to measure an adult patient’s full disclosure ECG record over
an extended period of time. The system is designed only for measurement,
recording, and display (bedside monitoring or intensive care monitoring excluded)
to assist a licensed physician in making a diagnosis.

The device is not intended to be used to direct cardiac contact, in operating

theatre, same time and place with high frequency surgical equipments or
defibrillator, and in a hazardous environment because of flammable anesthetic
mixtures or possibility of ingress of water.

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

BP4CT2KT_UMEN_V06_20211005 24
 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 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.

Indications for Holter and Event ECG monitoring

The following indications are listed for non-pediatric patients within the 2017
ISHNE-HRS expert consensus statement:

a) Detection of transient episodes of cardiac arrhythmias, permitting

correlation of these episodes with current cardiovascular symptomatology.
b) Detection of abnormalities of cardiac rhythm or electrocardiographic
morphology associated with symptoms of syncope, near syncope,
palpitations, chest pain suggestive of cardiac ischemia, shortness of breath
on exertion, and recurrent congestive heart failure where arrhythmia is the
suspected cause.
c) Evaluation of arrhythmias in the patient with documented coronary artery
disease, including the assessment of the immediate postmyocardial
infarction patient.
d) Detection of arrhythmias (such as atrial fibrillation) in patients with acute
stroke or TIAs.
e) Assessment of patients with implanted pacemakers or defibrillators, but
only when patients have symptoms suggestive of arrhythmia not revealed
by the standard ECG or defibrillator event recordings, or by analysis of the
pacemaker or defibrillator devices.
f) Monitoring the effectiveness of antiarrhythmic therapy.

BP4CT2KT_UMEN_V06_20211005 25
Indications for motion detection function
a) CT2 actigraphy, or motion detection is suitable for distinguishing whether
the patient was in vertical or horizontal body position (lying down or
standing upright) or whether he/she was in motion or was motionless in
cases of blood pressure or ECG protrusions (or extreme deviations).
b) For example, a tachycardia of a vigorously moving or a calm patient shall be
assessed separately.
c) Motion detection can be turned on/off during programming in
CardioVisions.
d) Motion detection does not support or justify any clinical decision. Motion
detection is recommended for research use only.

Contraindications
a) non-cooperative patients,
b) unconscious or otherwise incapable patients,
c) patients requiring urgency/emergency cardiac care,
d) patients with sensitivity/allergy to adhesive ECG electrodes,
e) patients with coagulation disturbances,
f) patients with serious mobility or other impairments without supervision,
g) Though the blood pressure measurement algorithm used in the monitors
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 in
patients with arrhythmias, Parkinson’s disease or other diseases with
tremor.
h) 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. The pregnant/pre-
eclamptic patients are also included in this adult patient-group.
i. Although Meditech does not have clinical investigation results on the
use of the ABPM-04 or card(X)plore (when measuring blood pressure)
in pregnancy, significant risks of application are not expected beside
appropriate medical care, since the oscillometric blood pressure
measurement method is state-of-the-art in the pregnant population
as well, and device settings are broadly variable in the Cardiovisions
and EasyABPM software. However, due to the sensitive population,

BP4CT2KT_UMEN_V06_20211005 26
 the clinical follow-up of patients during device use is strongly
recommended.

13 Possible Accessories list

Device accessories may vary from order to order.

Name Type/ID Note

ABPM-04 and card(X)plore
Pouch Pouch (P01) pouch for the recorder
with shoulder and waist
straps
Cuff normal BP4-A010-MED -
USB interface cable UO0 interface -
User Manual (EN) BP4CT2KT_UMEN_VXX Data carrier and printed
version
Alkaline battery Standard, commercial Minimum 1600 mAh,
AA 4 pcs
Patient diary (HU/EN) BP4_CT2_patient_diary_revXXHU Data carrier and printed
BP4_CT2_patient_diary_revXXEN version
Information for Patients BP4CT2USER_HU_XX Leaflet
BP4CT2USER_EN_XX
only card(X)plore
Memory card SD Commercial
ECG cable Bernd Richter LD07 001/577-001 7 lead ECG patient cable
ECG electrodes Cardinal Health/Covidien Kendall H34SG 1 Pack
Data carrier USB pendrive

BP4CT2KT_UMEN_V06_20211005 27
14 Technical Specifications
Technical Parameters ABPM-04 card(X)plore

power supply 4 AA rechargeable NiMH batteries or 4 AA alkaline batteries

display liquid-crystal
data storage internal solid state memory removable flash memory card

data transmission USB optical cable USB optical cable, a card reader is
needed for retrieving data
operating temperature 10-45 °C
(cuff: 10-40 °C)
operating humidity, non- 10-95%
condensing
operating atmospheric pressure 83-103 kPa
storage & shipping temperature -20 - 50 °C

storage & shipping humidity, 10-95%

non-condensing
size 82*124*33.5 mm
weight (batteries incl.) 330 g
blood pressure measurement oscillometric
method
blood pressure maximum over 600 measurements min. 400 programmed measurements
storage
measurement range (blood 30 - 260 mmHg (4-35 kPa) & 40-200 bpm
pressure & pulse)
passive accuracy (blood +/- 3mmHg (0,4 kPa) or +/- 2% of measured value (stability: 2 years)
pressure)
blood pressure measurement measuring algorithm validated to BHS & AAMI protocol
accuracy
pressure sensor piezo resistive
inflation automatically controlled pump
safety maximum inflation 300 mmHg (40 kPa), independent safety release valve
deflation & rapid air release automatic pressure release valve
actigraphy NA 2-axis polysilicon accelerometer
actigraphy measurement range, NA +/- 1,7g min, 10hz, better than 0,01g
sampling and sensitivity
ECG electrodes NA standard Holter, 3 independent
channels, separate ECG lead off
detection
pacemaker detection NA 2-level hardware

ECG sampling rate NA 600 Hz (storage: 300Hz)

ECG frequency response and NA 0.05-100 Hz (-3dB); 4uV, 12 bit

A/D resolution
ECG input dynamic range and NA 16 mVpv; 100 Mohm
impedance
ECG DC offset tolerance NA +/- 300mV

ECG storage NA 12-51 hrs

ECG filters NA baseline anti-drift, adaptive powerline

hum & muscle noise filter

BP4CT2KT_UMEN_V06_20211005 28
15 Troubleshooting
15.1Error codes
error codes ABPM-04 card(X)plore
measurement error
E1: the measurement timeout is over, the ✓ ✓
measurement had to be aborted (the patient was
moving)
E2: the measurement was stopped by pressing a ✓ ✓
button or one of the buttons were pressed and held
(more than 30 secs) therefore the automatic
measurement did not start.
E3: battery rundown ✓ ✓
E4: batteries replaced ✓ ✓
E5: the previous measurement was too close (the  ✓
minimum time restriction between 2 automatic BP
measurements was not over)
E8: the pressure in the pneumatic system exceeded the ✓ ✓
preset pressure limit
E9: temporary disturbance (external electric signal - ✓ ✓
static discharge - disturbed the operation of the device)
cuff error
E:31 there was no cuff connected to the device or the ✓ ✓
cuff was too loose on the patient's arm
E:32 the cuff is clogged or the rubber tube is broken ✓ ✓
E:33 there is a hole in the cuff or it is very loose on the ✓ ✓
patient's arm
E:34 The patient did not wear the cuff ✓ ✓
flash card error
E40: the measurement plan is not running  ✓
E41: there is no flash card in the device/the flash card  ✓
is inserted incorrectly/there is a communication error
E42: incompatible card or no data, the inserted flash  ✓
card is incompatible or it does not contain
measurement data
E43: different measurement plan, the flash card does  ✓
not belong to the running plan
E44: faulty plan, the measurement plan is damaged or  ✓
contains incorrect parameters
E45: date independent plan, time limit exceeded  ✓
between creating and starting of the measurement
plan.
device error
E90: device error (the device could not measure due to ✓ ✓
a hardware error)
E99: device error (the device does not start automatic ✓ ✓
measurement until the next programming)

BP4CT2KT_UMEN_V06_20211005 29
If you need support, please check out the following website:
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 as possible:
https://www.meditech.hu/en/troubleshooting.html

16 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 recorder 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 recorder unit only. This warranty
does not cover any accessories that might come with the recorder unit.

ACCESSORIES WARRANTY. The non-disposable accessories delivered with the

recorder unit 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 recorder unit - 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

BP4CT2KT_UMEN_V06_20211005 30
product with the warranty card. This warranty does not cover any malfunction or
defects of the recorder unit or any of its accessories arising from improper use,
the use of inadequate accessories, accident, theft, or use of the recorder unit
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 recorder unit
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 recorder unit, 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

BP4CT2KT_UMEN_V06_20211005 31
use.

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.

17 References
ABPM-04 and card(X)plore monitors, and the CardioVisions and EasyABPM
software are manufactured and developed by Meditech Kft. All title and copyrights
in and to the CardioVisions/EasyABPM software, the accompanying electronic and
printed materials, and any copies of the CardioVisions and EasyABPM software
are owned by Meditech Kft. CardioVisions and EasyABPM software are protected
by copyright laws and international treaty provisions. For details, please read the
software license agreement.

Meditech Kft.
1184 Budapest, Mikszath Kalman 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.
2092 Budakeszi, Erdő utca 101., Hungary
Tel: +36 23 880 830

BP4CT2KT_UMEN_V06_20211005 32
 Always consult a physician for the interpretation of the measurements. Note
that any recording may be affected by the body position, the physiological
condition of the patient, and other factors.

! No user serviceable parts inside. Meditech recorders contain high complexity

electronic and fine mechanical components. If you have any problems, please
refer your recorder to qualified service personnel. The device cannot be
modified by the user!
REF Device type (BP4 = ABPM-04, CT2 = card(X)plore)
BP4 or CT2
Certification mark of the Russian Federation.

Direct current

Follow the User Guide.

This signal directs attention to the description of that part.

Manufacturer

Date of production

Uo0 Identification of USB optical interface

Device corresponds 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 Notified Body (CE Certiso)

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

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.)

BP4CT2KT_UMEN_V06_20211005 33
 IP22 Protection against environmental impact: First digit "2": Protected against mid-sized
solid objects (>12 mm). Second digit "2": Protection against vertically falling water
drops when enclosure tilted up to 15°).
The monitors are internally powered type CF devices. Protection vs. ingress of
water: none. Mode of operation: continuous. The devices are not protected against
defibrillators or other high frequency surgical equipment.

SN
YYYY/NNNNNN or The serial number is situated on the backside of the device. Y: the year of
YYYYxxxNNNNNN manufacturing; x device type (where applicable), N: serial number. For example:
2007/123456 or 2011CT200000533

This symbol shows that according to regulations the monitors should be handled as
electronic waste during rollout.

Blood pressure measurements determined with the algorithm of a Meditech

recorder 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 the recorders also fulfills the
requirements of the British Hypertension Society Validation Protocol for Automated
Blood Pressure Measuring Devices.

18 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.

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-04 device, including cables. Otherwise, degradation in the
performance of this equipment may be expected.

BP4CT2KT_UMEN_V06_20211005 34
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!

BP4CT2KT_UMEN_V06_20211005 35