Ambulatory Blood Pressure Monitor

Cardiospy® User Manual

LABTECH LTD.

Address 4 Vág street, Debrecen Hungary H-4031

E-mail (technical support) [email protected]

E-mail (sales) [email protected]

Phone +36-52-500-128

Fax +36-52-500-129

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QUALITY CERTIFICATIONS AMBULATORY BLOOD PRESSURE MONITOR

Quality certifications
The CE mark indicates that the product meets the essential requirements of European
Council Directive 93/42/EEC concerning medical devices.

Labtech Ltd. also operates a quality system certified to ISO 13485:2016. Made in
Hungary by Labtech Ltd.

We wish you success in the use of our

ABPM System!

Release date: 11-08-2011

Revision date: 10-05-2018
Version number: v6.1

If you have any questions, ideas, partnership suggestions please contact us.

LABTECH LTD.

Address 4 Vág street, Debrecen Hungary H-4031

E-mail (technical support) [email protected]

E-mail (sales) [email protected]

Phone +36-52-500-128

Fax +36-52-500-129

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AMBULATORY BLOOD PRESSURE MONITOR TABLE OF CONTENTS

Table of contents
1 INTRODUCTION.................................................................................................... 6
2 PREPARATIONS .................................................................................................... 7
2.1 List of accessories ...........................................................................................7
2.2 Principles of Operation ...................................................................................9
2.3 Warnings and contraindications to using ABPM system .............................. 11
3 MAIN FUNCTIONS ............................................................................................. 13
3.1 Main parts of the ABP Monitor ....................................................................13
3.2 Signs and alarms of ABP ..............................................................................14
3.3 Database management interface ....................................................................17
3.4 Toolbar ..........................................................................................................17
3.4.1 Settings: ....................................................................................................18
3.4.2 Help ..........................................................................................................20
3.4.3 Records toolbar .........................................................................................21
3.4.4 Selected System ........................................................................................23
3.4.5 Filters ........................................................................................................23
3.4.6 Search .......................................................................................................23
3.4.7 Database information ................................................................................24
3.5 How to start a new recording? ......................................................................24
3.5.1 Patient preparation ....................................................................................24
3.5.1.1 Attach the cuff to the patient‟s arm ..................................................24
3.5.1.2 Attach the adhesive cuff anchor .......................................................24
3.5.2 New Recording .........................................................................................25
3.5.2.1 Start recording via Bluetooth ...........................................................26
3.5.2.2 Start recording via USB cable ..........................................................28
3.5.2.3 Start recording without prespecified patient data ............................. 29
3.5.3 Measurement settings ...............................................................................29
3.5.4 Informing patient about batteries and further instructions ........................30

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3.6 How to read a record?................................................................................... 31

3.6.1 In case of normal records (via USB cable or Bluetooth) .......................... 31
3.6.2 In case you have started the recording without prespecified patient data 32
3.6.3 Patient data protection .............................................................................. 33
4 ANALYSIS WITH CARDIOSPY SOFTWARE ................................................... 35
4.1 Views ............................................................................................................ 35
4.1.1 HR, BP graph ........................................................................................... 35
4.1.2 Table ........................................................................................................ 36
4.1.3 Charts ....................................................................................................... 36
4.1.4 Graphs ...................................................................................................... 37
4.1.5 Histograms ............................................................................................... 37
4.1.6 Statistics ................................................................................................... 38
4.1.7 Scatter ...................................................................................................... 38
4.2 Toolbar ......................................................................................................... 39
4.2.1 Database ................................................................................................... 39
4.2.2 Report ....................................................................................................... 39
4.2.3 Sequence of tasks ..................................................................................... 39
4.2.4 Print .......................................................................................................... 39
4.2.5 Export ....................................................................................................... 39
4.2.6 Settings ..................................................................................................... 40
4.2.6.1 Parameters... .................................................................................... 40
4.2.6.2 Colours... ......................................................................................... 41
4.2.6.3 Continuous playing.......................................................................... 41
4.2.6.4 Automatic analyzing after read ....................................................... 41
4.2.6.5 Refresh / Analysis mode... ............................................................... 42
4.2.6.6 New analysis ................................................................................... 42
4.2.6.7 Service ............................................................................................. 42
4.2.6.8 Control panel... ................................................................................ 42

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AMBULATORY BLOOD PRESSURE MONITOR INTRODUCTIONTABLE OF
CONTENTS
5 PRINT AND EXPORT .......................................................................................... 43
5.1.1 Parts of the Print view ...............................................................................43
5.1.2 Print view settings.....................................................................................44
6 CALCULATION AND EVALUATION METHODS ........................................... 45
6.1 General calculation methods .........................................................................45
6.2 Morning Surge .............................................................................................. 46
7 TROUBLESHOOTING AND MAINTENANCE ................................................. 47
7.1 Sending a bug report .....................................................................................47
7.2 Calibration and maintenance .........................................................................48
7.2.1 Calibration ................................................................................................ 48
7.2.2 Maintenance .............................................................................................. 48
8 TECHNICAL SPECIFICATIONS ....................................................................... 49

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INTRODUCTION AMBULATORY BLOOD PRESSURE MONITOR

1 Introduction
Dear Customer,
Thank you for purchasing our Ambulatory Blood Pressure Monitor System. We
sincerely hope that our product will help you with your diagnostic and therapeutic work.
To be able to use ABPM System and computer program appropriately, please read the
manuals carefully. A basic knowledge of computers and Windows-based applications is
required. We appreciate any comment you might have on the use of the System. Please,
turn to us with confidence: our colleagues and representatives will be pleased to help
you.

What is an Ambulatory Blood Pressure Monitor (ABPM)?

The Ambulatory Blood Pressure Monitor is a non-invasive Oscillometric Blood
Pressure Monitor, which is capable of recording up to 1.000 measurements.

How to use ABP monitoring?

The ABP monitor is worn by the patient, and records ambulatory blood pressure during
normal daily activities. After it has been recorded for the desired period of time, the
readings are downloaded to a computer for analysis.

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AMBULATORY BLOOD PRESSURE MONITOR PREPARATIONS

2 Preparations
NOTE: BEFORE STARTING TO USE THE ABPM SYSTEM YOU ARE EXPECTED TO FOLLOW
INSTALLATION AND UPDATE GUIDE OF LABTECH LTD., WHICH PROVIDES GUIDANCE ON
THE INSTALLATION OF THE SYSTEM.

2.1 List of accessories

Please check contents of the case for listed items and accessories before you start using
the ABPM System.

EC-
Code No. Specification Qa. Picture
ABP

Case for holding the

CAS-
ambulatory blood 1 x
00ABP-01
pressure system

ACC-
CD with installation 1 x
0SWCD-01
software

DEV- USB-02/A Bluetooth

1 x
0USBA-02 Interface Unit

DEV- EC-ABP recorder unit

1 x
00ABP-05 (BT)

CHA-
Battery charger MAXI 1 x
0004X-01

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EC-
Code No. Specification Qa. Picture
ABP

BAT- 1.2V Rechargeable

4 x
00000-02 batteries (AA)

CAB-
Extension cable for 1 x
00USB-01
USB-02

CAB- USB data transfer cable

1 x
00USB-02 (USB A- USB Mini)

USR-00000- Installation and Update

1 x
01 Guide

USR-00000- User Manual for ABP

1 x
03 recorders

Recorder bag (EC-ABP

BAG- V5, EC-3H/ABP V5,
1 x
3HABP-02 attachable to patient's
waist belt)

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EC-
Code No. Specification Qa. Picture
ABP

BEL-00000-
Waist belt 1 x
01

CUF- BP cuff, Adult (17-

1 x
00LOC-21 25cm)

ELE-00000- Single-use electrodes

1 x
02 for cuff fixing

*The manufacturer maintains the right to change at any time.

**The accessories highlighted in grey in the chart will be given as accessories for
the recorders as well.

NOTE: PLEASE REFER TO THE CODE NUMBER ABOVE WHEN PLACING AN ORDER.

2.2 Principles of Operation

This device 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 Ambulatory Blood Pressure Monitor unit is worn by the patient either in a waist
belt or shoulder strap and is connected to a traditional cuff around the non-dominant
upper arm. The cuff is inflated automatically at intervals that can be programmed via
the software. Blood pressure is measured by oscillometric method, which senses the
cessation of pressure waves in the artery when occluded by pressure in the cuff.
Measurement of the frequency of the pressure waves also enables heart rate to be
measured.

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Symbols:

This equipment meets the requirements of Directive 93/42/EEC Annex II

(excluding section 4).

Do not dispose of this product and batteries as unsorted municipal waste.

Prepare this product for reuse or separate collection as specified by Directive
2002/96/EC of the European Parliament and the Council of the European
Union on Waste Electronic and Electrical Equipment (WEEE).

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

Bluetooth Wireless Communication Technology

Not ionizing radiation – Device including Bluetooth based RF transmitter.

Pay special attention to the part, marked with the exclamation mark.

CF type side of patient

Year of manufacture

Manufacturer

Operating instruction

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AMBULATORY BLOOD PRESSURE MONITOR PREPARATIONS

2.3 Warnings and contraindications to using ABPM system

General warnings:
DO NOT immerse the recorder in any fluid, or attempt to clean the unit with any liquid
detergents or cleaning agents. This may cause an electrical hazard.
DO NOT disassemble the recorder case – doing so automatically invalidates the
warranty. Using a component different from that supplied may result in measurement
error.
DO NOT use the recorder in the presence of flammable anaesthetics and oxygen rich
environment.
DO NOT use recorders in strong heat or in strong electrostatic field.
DO NOT use the recorder if it has failed its diagnostic self-test, or if it displays greater
than zero pressure with no cuff attached. The values displayed by such a unit may be
inaccurate.
DO NOT use on neonates, on patients known to be susceptible to bruising, and do not
attach the cuff to a limb being used for IV infusions.
The ABPM System is designed for external and non-invasive blood-pressure
monitoring on the arm. The cuffs can be placed on intact skin-surface only.
The patient should be instructed on proper and safe removal of the cuff, in case it fails
to deflate within 3 minutes.
Avoid compression or restriction of pressure tubes.

Possible Adverse Reactions:

Allergic Exanthema (symptomatic eruption) in the area of the cuff Urticaria (allergic
reaction including raised edematous patches of skin or mucous membranes and intense
itching) caused by the fabric material of the cuff.
Petechia (a minute reddish or purplish spot containing blood that appears in the skin).
Rumple-Leede phenomenon (multiple petechia) on the forearm.
Idiopathic thrombocytopenia (spontaneous persistent decrease in the number of platelets
associated with hemorrhagic conditions).
Phlebitis (inflammation of a vein).

Environmental conditions of storage and operation

Temperature-range: -10-50oC
Relative humidity: 10-95% non-condensing

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Air pressure-range: 700-1060 hPa

Opening the enclosure by unauthorized person may invalidate warranty. Modification of
the ME equipment can only be performed by the manufacturer. In case of problems
contact a professional repair shop.

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 AMBULATORY BLOOD PRESSURE MONITOR MAIN FUNCTIONS

3 Main functions
3.1 Main parts of the ABP Monitor

Front view Extended Pneumatic tube

Cuff
Warning
LED

Event Button

Cuff anchor

Rear view

Symbols

Serial number

Two AA batteries

Battery cover

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3.2 Signs and alarms of ABP

The recorder contains a single RGB LED which with you can indicate several colours
and hues.

Light signal Description What should we do?

After detecting the hardware error the

device waits a few seconds and restarts
The LED light is automatically. If it does not then you
Hardware error.
red. need to restart the recorder by replacing
the batteries. If the problem still occurs
it requires repairing.

The LED is red

The battery has run out. Battery exchange is required.
and flashing.

The recorder connects

The LED light is to the PC through the
-
green. USB data transfer cable
and it works properly.

The recorder connects

to the PC through the
USB data transfer cable
and there is data
The green LED transfer between the
light flashes PC and the recorder. -
quickly.
The rhythm of the
flashing is
synchronized with the
rhythm of data transfer.

The recorder is ready to

start recording (doesn‟t
contain any unread
The green LED
records, the self-test -
seldom flashes
and initialization was
successfully
completed).

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Light signal Description What should we do?

The yellow LED The device is

-
flashes. recording.

You need to read the last record from the

The crimson LED The recorder contains recorder, otherwise you cannot start the
flashes unread record. next record and the device won‟t turn on
the Bluetooth module.

There is Bluetooth
The Blue LED
connection between the -
seldom flashes
PC and recorder.

There is data transfer

The Blue LED
between the PC and -
flashes quickly
recorder.

The recorders include a buzzer which can operate in different frequencies. By this the
recorders are able to indicate the different statuses and errors.

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Sound signal Tone Description

Event button is pressed on the

One high-pitched short beep  recorder or on the PC (Start/Stop
BP).

The device was removed from

One short beep in deep voice 
the USB.

Start of recording.
One high-pitched long beep 
Stop of recording.

The recorder beeps for some

Hardware error.
seconds on a high-pitched voice.

Cannot start recording (no patient

data).


Event button is pressed, but there
Two high-pitched short beep
is no function related to pushing
the button in the current state of
the recorder (for example: the
recorder connects to the USB).

The device has been connected to

Two short beep in deep voice 
USB.


Bluetooth connection has been
Two short beep with rising melody
created.

Two short beep with descending Bluetooth connection has been


melody broken.

After the battery was put in the

Three high-pitched short beep  initialization, self-test was
successfully completed.

Four high-pitched short beep  Discharged battery.

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3.3 Database management interface

The database management interface enables us to add physicians and patients by name
and ID number (e.g., social security number), which can be sorted and filtered
according to different criteria. The interface also offers a search option by name or ID.
The database management interface displays the list of patients and the pertaining
number of records. Here we can view previous records and start new recordings as well.
3.4 Toolbar
The toolbar contains different buttons which provide access to the most often used
functions in the software.
New patient: Here you can add new patients to the list. Patient‟s first and
last names, date of birth and patient IDs are fields which need to be filled in.
The software allows only unique patient IDs to be entered into the database,
which is the reason why it is recommended to use this field for entering the social
security number of each patient (or any other code which uniquely identifies a person).
Entering address, weight and height is optional when registering a patient.
Modify: Patient data can be edited by clicking on the Modify button. The
interface allows every field to be edited except patient ID (social security
number)
Medical record: This function gives a summary about the medical record.
This summary can be edited and we can also add explanations and
observations.

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Delete: Click on the Delete button for deleting patients. When patient is
deleted, all of its corresponding records are deleted as well. After deleting,
there is only one way to restore data. If the “Move deleted records to recycle
bin” option is turned on (Settings/Administration/Settings) you can restore the
deleted record from the “Record recycle bin”. We suggest you to turn this function
before you start using the software to prevent data loss.
3.4.1 Settings:
- Select physician: In this menu the physician, who is
performing the current test, can login to the software
and also select to view the records of other physicians
whose records are not password protected.
- Change password: By selecting this option, the
physician, who is performing the current test, can
change his/her password.
- Administration: Here, we can manage the users and
also the security settings and administrator rights can
be set under this menu point. Further information on
modifying user authorization can be found in
Cardiospy Installation and Update Guide.

- Select database: In this menu, you can choose to

create a new database or to use a different one.
These databases operate independently of each
other, so a patient who is created in one of them
does not appear in another. The software always
uses the database set for the previous operation.
Clicking on the “Add” button creates a new
database.
If you need to work with a different one, then select it and click on “OK”.
You can move a database to a different location with the “Move...” function. If the
“Move…” operation is interrupted all the files will be restored in the original folder.

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There are three possible ways to create a database:

Local database
Network mode - Microsoft SQL Server
SQLite database
Local database:
The database is stored in a local directory on
your computer. Network drives are not
supported.
It is optimal for single computer usage.
Select the directory for the database and it is
ready.

Network mode - Microsoft SQL Server:

Please ask for help from your administrator.
SQLite database:
You can find its description in the Cardiospy Installation and Update Guide.
- File names as: The order of first and last name can be set in this menu.
- Input devices: Barcode readers and magnetic card readers can be set here.

- FTP settings: You can find its description in the Cardiospy Installation and Update
Guide.
- Communication: You are able to
communicate through HL7 between Cardiospy
and external software. To setup this, ask your
local distributor and administrator.
- Select systems:
Here, you can enable / disable systems that you
want / do not want to use.
You can activate or deactivate a system by
ticking or un-ticking the checkbox next to the
name of it.

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3.4.2 Help
- Installation and update guide: The guide on software
installation and system configuration also contains a
description of the software update process.
- User manual: First of all, choose the system in the Select
systems panel. Once you click on User manual button, the user
manual of the currently selected system will appear.
- What’s new: The novelties of the current software version
can be found in this file.
- Languages: The software offers a choice of several languages, from which you can
select the one you wish to work in.
- Multilanguage translator: With this function, the user is able to translate each term
which appears in the software into the desired language. A password is necessary to
enter this menu point. In case you would like to use this function, ask your distributor
for the password.
- About: Information about the software version, the operating system and the
copyrights can be found here.
- Device Connection Status Indicator: This indicator shows the current connection
status of the devices (the USB-02 interface, the ECG recorder, the blood pressure
monitor and the stress device).
The Device Connection Status Indicator has three types: the first one is used with the
Holter, ABP and Resting Test systems. The second type is used with the Stress Test
systems, and the third type with the Continuous ECG systems.
1 1 1
2 2 3 4 5 2 3 5
.
1. Status of Bluetooth or direct connection
2. Status of connection with Holter ECG recorder /ABP recorder / Resting ECG
recorder / Test ECG recorder
3. Status of connection with blood pressure monitor
4. Status of connection with loading machine
5. Status of connection with Pulse Oximeter (this section is only available when Pulse
Oximeter is activated under System Configuration menu).

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Colour codes for the ECG Devices Connection Status Window:

Green - The device is properly connected
Yellow - Manual operation, the device is not connected to the computer
Red – No connection with the device
Grey – No connection is needed for recording
3.4.3 Records toolbar
This is a toolbar for managing existing records.
Load record: Opens the selected record from the list. Once the record is open
we can edit, analyze or print it.
- Import: There are three methods to import records:
Import records: With this function we can import
records from a directory of our choice.
Import records by date: You can import records
from an existing folder within a date interval.
Import sample data: It is only working if you have
the installation DVD inserted into the PC. This function will import demo records
from it into your database.
The imported records are automatically saved into the current database.
- Export: In this menu point we can save the current
record to an existing folder of our choice. This directory
can also be on a network drive or on a portable drive
(e.g., USB stick).
There are five methods to export records:
Export selected records: If you have single or
multiple records selected, then you can export them
with this function.
Export records by date: You can export records to an existing folder within a date
interval.
Export records of selected patients: If you have a single or multiple patients
selected, then you can export all of their records at once.
Export all spirometry records: With this function, you are able to export
spirometry records.

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Export anonymous records: You can export records without the personal data of
the patient.
- FTP - upload and download:
To set an FTP server, please check Cardiospy Installation and Update Guide.
Upload to FTP: We can select multiple records from
a single patient and upload them to the currently
connected FTP server.
Upload to FTP by date: You can upload records
within a date interval.
Upload to Labtech: In case you have any problem
with the records, then you can upload them to the
Labtech server.
Furthermore, you have the possibility to automatically upload records to FTP. You can
enable it in the “System configuration” / “Settings” menu.
Download from FTP: We can download records from the currently connected FTP
server. You can select multiple records to download at the same time.

- Print rest records by date: You are able to print every Rest record of the selected
physician within a date interval.
- Delete records:
Delete selected record: This buttons deletes every selected
record from the database. You can only restore them from the
record recycle bin (if it is enabled in the settings). You can
enable it in the Administration / Settings by set “Move
deleted records to recycle bin” to “Yes”.
Delete records by date: It deletes every record within a date interval.

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Delete all records: It deletes every record.

3.4.4 Selected System
Here you can select the ECG systems you wish to use,
configure systems, add new recorders before you start
recording. You can also start Demo recording in this field.
Please keep in mind that a demo recording can only be started
if the USB-02 device is not connected to the PC.
3.4.5 Filters
This field provides a few filters which enable the filtering of
records by different criteria.
You can filter records by:
- Physician: You can filter the database to show records made
by the selected physician only.
- Date: When this filter is used, you can only see the records
that were made today / in the last 2 days / in the last 7 days /
this month / this year.
- Status: You can filter records by their current status (Temporary, Pre-evaluated,
Evaluated, Approved).
- Record type: You can filter records by device types.
- Pacemaker: You are able to filter records with or without pacemaker.
By default, no filter is enabled, the database shows every records.
3.4.6 Search
In this search-bar you can filter patients by typing characters that matches any of the
patient‟s personal data.

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3.4.7 Database information

Hover the mouse over the disk space info bar
between the patient and record list and a
small field appears which contains general
information about the database, such as
access path, number and size of records
contained, etc.
3.5 How to start a new recording?
3.5.1 Patient preparation
3.5.1.1 Attach the cuff to the patient’s arm
It is important to select the cuff size that is appropriate for the
diameter of the patient‟s upper arm.
The cuff may be worn over a thin shirt, without compromising
accuracy or performance. However, it is recommended that the cuff
be secured using the cuff anchor.
Ensure the air hose from the monitor to the cuff is not compressed,
crimped or damaged.

Please remember that using the wrong cuff size may result in inaccurate readings.
3.5.1.2 Attach the adhesive cuff anchor

With the patient cable draped over the patient‟s shoulder, attach an
adhesive cuff anchor to the snap on the hose of the cuff bladder.
Do not remove the adhesive backing of the cuff anchor at this time.

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3.5.2 New Recording

First of all, you have to connect the device to the PC, the software will read the record
(that was made at the final measurement) in from the device automatically and open the
record viewer.
You can read about how to read a record in the CHAPTER 3.6. You can start recording
only from the database screen.
If you already have your device(s) registered in the list of the recorders, then you can
start to work with it/them.

BEFORE STARTING A NEW RECORDING, YOU HAVE TO READ THE

PREVIOUS RECORD FROM THE DEVICE

You can start a new recording in three possible ways:

- Via Bluetooth: By this way, you can start a test BP measurement, then start the
recording from the PC, while the recorder is already attached to the patient. The patient
data is automatically programmed to the device.
- Via USB cable: This way you do not have the ability to start a test BP measurement,
but it makes the process quicker. You have to start the recording by pushing the “Event
button” on the device for 3 seconds after programming the patient data to it.
- Without prespecified patient data: This method is used in big hospitals where you
have to start recording as quickly as possible. This way you do not have to go through
the patient data programming process at the start. You can start recording by pushing
the “Event button” on the device for 3 seconds. You have to register the patient while
reading the record from the device.

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3.5.2.1 Start recording via Bluetooth

To start a new recording via Bluetooth connection, please follow these steps:
1. Make sure the USB-02 dongle is connected to the PC and working
properly.
2. Make sure the Ambulatory BP system is selected at the Selected System menu.
3. The device must not be connected to the PC.
4. Add or Select a patient who you want to examine.
5. At the Selected System / Ambulatory BP menu, click on
“START recording”.
6. Select the device from the list with the proper serial number and then click on
the “Start monitoring with the selected recorder” button.

7. In the next window, you can set the measuring parameters for the recording.
For further information about the “Holter Monitoring Settings” window, please
check CHAPTER 3.5.3. After you are done
with the settings, click on the “Start
monitoring” button.

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8. Here, you can start a test BP

measurement by clicking on the
“Start BP” button.

9. From this point, you can continue

the process two ways:

a. Start the recording from the software:

1. If you are satisfied with the result, you can start the recording by clicking on
the “YES, START recording” button.
2. After you have started the recording
successfully, a new window will pop up in
which you can print the patient diary.

3. If the device is started to recording

successfully, then the LED on it should
flash in yellow colour and you can hear
one high-pitched long beep.

a. Start recording remotly from the device:

1. If you want to continue this way, then click on the „Cancel” button.
2. Hold the “Event button” on the recorder for 3 seconds to start recording.
3. If the device is started to recording successfully, then the LED on it should
flash in yellow colour and you can hear one high-pitched long beep.

Please check CHAPTER 3.6 about how to read a record.

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3.5.2.2 Start recording via USB cable

1. Make sure the Ambulatory BP system is selected at the Selected System menu.
2. The device must be connected to the PC.
3. Add or Select a patient who you want to examine.
4. At the Selected System / Ambulatory BP, click on “START
remote recording”.
5. Select the device from the list with the proper serial number and then click on
the “Start recording without PC” button.

6. In the next window, you can set the measuring parameters for the recording.
For further information about the “Holter Monitoring Settings” window, please
check CHAPTER 3.5.3. After you are done
with the settings, click on the “Start
recording” button.
7. After the successful programming,
a new window will pop up in
which you can print the patient
diary.
8. Hold the “Event button” on the
recorder for 3 seconds to start
recording.
9. If the device is started to recording
successfully, then the LED on it
should flash in yellow colour and
you can hear one high-pitched long
beep.
10. Please check CHAPTER 3.6 about how to read a record.

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3.5.2.3 Start recording without prespecified patient data

1. To make this work, you have to enable an option in the Settings / Control Panel
/ Reading and recording settings. Tick the checkbox next to the “Enable Holter
recording without prespecified patient data” text and then click “OK”.
2. Connect the device you wish to use to the PC.
a. If you have not worked with this device before, please follow the
instructions in CHAPTER 3.5.2.1 or CHAPTER 3.5.2.2 and then start
this process over from point 2/b.
b. If it has a record in it, the Cardiospy will read it first. This way the
software will automatically be programmed as a “dummy patient”
with the last measuring settings. For further information about the
“Holter Monitoring Settings” window, please check CHAPTER 3.5.3.
3. Disconnect the device from the PC.
4. Hold the “Event button” on the recorder for 3 seconds to start recording.
5. If the device is started to recording successfully, then the LED on it should
flash in yellow colour and you can hear one high-pitched long beep.

6. Please check CHAPTER 3.6 about how to read a record.

3.5.3 Measurement settings

Patient tab: When starting a new recording,
there is an opportunity in the software to
enter the name of the doctor who requested
the examination, the medication and the
symptoms of the patient. The information
will be stored if you read it on a PC.
At the Measurement tab you can find the
settings of the awake period that you can
also modify after the record was read. You
can also set the frequency of the BP
measurement the maximum pressure of the
cuff and right after the output of the recorder
it is able to measure.

Miscellaneous tab: Here you can disable to

load the record after reading (on by default).

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3.5.4 Informing patient about batteries and further instructions

Note that the patient can safely change the batteries at any time. The recording will
continue until the device runs out of memory or connected to the PC for reading.
Please also provide the following instructions to your patient:
• The patient can mark events (e.g. exercising, feeling pain or nausea, etc.) by
the “Event button”, so the doctor can measure the ECG and BP values at these
times.
• The patient can stop a BP measurement in progress by pressing the Event
button. Starting a BP measurement is also possible at any time with this button.
• When the pressure in the cuff increases, the patient should avoid excess
movement. Let the instrumented arm hang loosely, slightly away from the
body. Avoid flexing the muscles or moving the hand and fingers of the
instrumented arm.
• While sleeping, the patient should make sure that the hose is not crimped.
• Inform the patient on how and when to fill out the patient diary.
• If the device or cuff causes extreme pain or pain not normally associated with
blood pressure measurement, the patient should remove the cuff and stop the
measuring.

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3.6 How to read a record?

The recording stops automatically if the device runs out of memory or connected to the
PC for reading.
During recording it is possible to replace flat batteries. The recording will continue.
It is advisable to remove the batteries first and then the cables from the electrodes.
For reading a record, please follow the steps below:
3.6.1 In case of normal records (via USB cable or Bluetooth)
1. Take off the recorder-case from the patient, remove the batteries and then
remove the cuff from him/her.
For faster reading process, please place fully charged batteries into the device before
you connect it to the PC.
2. Start the Cardiospy program on the
computer. Then select the Ambulatory
BP system.
3. Connect the recorder to the USB reader
cable. The reading will start
automatically (by default).
4. After the software finished with the
reading, the “Record viewer” window
will appear where you can analyze and
evaluate the record.
5. If the automatic analyzing is enabled
(see CHAPTER 4.2.6.4), an analyzing
process will be performed.

6. Now you can start to examine and edit the record. See CHAPTER 4.

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3.6.2 In case you have started the recording without prespecified patient data
1. Take off the recorder-case from the patient, remove the batteries and then
remove the cuff from him/her.
For faster reading process, please place fully charged batteries into the device before
you connect it to the PC.
2. Start the Cardiospy program on the computer. Then select the Holter system.
3. Connect the recorder to the USB reader cable. The reading will start
automatically (by default).
4. Since the recorder was started without prespecified patient data, thus you have
to fill the personal data at the beginning of the reading process in a pop-up
window.
5. Since the recording was started without any PC
connection, you have to verify the date and time
when the recording was started.
6. Click “Next” and then type the ID of the patient.
7. Click “Next” again and then fill the personal data
of the patient.
8. Click “Finish”. A confirmation window will pop
up.

9. After the software finished with the reading, the

“Record viewer” window will appear where you
can analyze and evaluate the record.
10. If the automatic analyzing is enabled (see
CHAPTER 4.2.6.4), an analyzing process will be
performed.

11. Now you can start to examine and edit the record. See CHAPTER 4.

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3.6.3 Patient data protection

From 25 May 2018, a new General Data Protection Regulation (GDPR) was enforced.
For this reason, our analysing software (Cardiospy) was improved to meet the necessary
expectations. Since every Holter record contains patient data in order to be able to
recover it at the reading phase, the data must be encoded to prevent it to be used by
unauthorized persons.
The encoding works based on an encoding key, which is automatically created at the
first usage of Cardiospy (6 digits random number), but it can be modified in the Settings
/ Control panel / Reading and recording menu.

To sum the above, you can only recover

the original patient data from a record,
if you are using the same encoding key
in your software (that same key which
was used for starting the recording),
otherwise, you will get a pop-up window,
that your key is invalid and you will be
prompted to enter the patient data
manually.
As you can see, the current key - "111111"
- is invalid, because the record was started
on another computer, where the code was
different from "111111".
You can continue to read the record by
clicking on the OK button, but as it was
mentioned above, you will be prompted to
enter the patient data manually. Works the
same way as the method used in CHAPTER 3.6.2.
You can only recover the original patient data, if you enter the original key into
the "Key" field. If you modify its value, you have the opportunity to decide if you
want to use the new key permanently or to just use it once and leave the current key in
your settings. To save the new key permanently, tick the "Use this key permanently"
checkbox!
If you have successfully entered the original data and you click on the OK button, then
the record will be read with the original patient data automatically - without re-entering
it. Cancelling this window will stop the reading process.

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It is always recommended to save your key, so in that case you have to move your
Cardiospy to another PC, you will still be able to read your pending records without any
inconvenience.

However, it is especially necessary to know the function of this key when you are using
the recorders on multiple computers:

• Start recording on a PC, then read the record on another PC.

• Star recording on multiple PCs, then read them on a single or on multiple

computers.

In that case where you are using multiple computers in a system, you will have to
set the same protection key for every computer (in Cardiospy) to be able to read the
records with the original patient data.

The data protection key itself only affect recorders where the patient data is actually
stored on the device: EC-ABP, EC-2-3-12H, EC-3H/ABP.

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SOFTWARE

4 Analysis with Cardiospy software

4.1 Views
This chapter provides information on the functions of the Cardiospy software regarding
Blood Pressure analysis.

4.1.1 HR, BP graph

The graph presents Heart Rate and Blood Pressure measured by the ABPM device.

The green line is showing the Heart Rate and the red marks are showing the BP
measurements.

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4.1.2 Table
The table displays all the BP results in a chronological order. We can validate /
invalidate each result by ticking / unticking the relevant checkbox in the column marked
“Valid”.
We can add short remarks to each measurement in the Comment column (double click).

4.1.3 Charts
The software represents systole and diastole values in the form of pie-charts.

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4.1.4 Graphs
The software shows BP burdens in the upper graph, while in the second graph Systole,
Diastole, MAP and HR values are displayed.

4.1.5 Histograms
In this part Systole, Diastole and Map values are represented in the form of histograms.

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4.1.6 Statistics
Statistical parameters calculated from the validated Blood Pressure and Heart Rate
values are shown in a table format.

4.1.7 Scatter
In this function, the cohesive systole-HR, diastole-HR and Systole-Diastole points are
displayed.

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4.2 Toolbar
4.2.1 Database
From this menu, you can go back to the patient database, save
the current record (it is recommended if you have made
changes in it), import and export record (even anonymously).

You can go back to the patient database more quickly with this button.
4.2.2 Report
By selecting the Report menu a text box appears in which you can write
remarks. When pressing the „Import Automatic Report‟ button both patient‟s
data and the automatic report of the program will be copied to this page. If
you have filled the Indication and the Medication box when you set up the
measurement settings then the content of the symptoms and medication fields will be
imported to the report, as well. The doctor‟s name will be imported to every report‟s
letterhead.
In the Print View, you will see the content of the Report as a new sheet “Report”.
4.2.3 Sequence of tasks
In this menu, you can follow through the whole operation from
reading in to the approving of the evaluated record.
When you have finished examining the Blood Pressure
measurements, you can tick the checkbox next to its name to
mark the record as “Evaluated”.
After you finished with the evaluating, you can mark the record
as “approved”, so it cannot be edited from then, until you untick
the checkbox next to it.
4.2.4 Print
In this menu we can go through all the reports prepared
by the software and print them separately.
4.2.5 Export
In this menu we can go through all the reports prepared by the software and export
them separately (JPG, BMP, PDF, etc).
You can learn more about print / export and its settings in CHAPTER 5.

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4.2.6 Settings
In this menu it is possible to set the various parameters
of the program, such as parameters relevant to the
analysis, colours of the screen, graphs to be displayed in
the Main/Events menu, etc.

4.2.6.1 Parameters...
Time:
Here, you can change the “Awake” and the “Special
time”. E.g. you can set when the patient was asleep if
you set the parameters of the “Awake” time to the
beginning and the end of the sleeping period.

Blood Pressure:
Here we can set parameters used for statistical calculations and measurement ranges
used for automatic pre-filtering. Limits for children and adults can be adjusted
separately.
Statistical Limit:
You can set the normal systole and diastole limits in
every interval separately (awake, asleep and special).
If the patient‟s result exceeds this limit the software
indicates that it is in a high range (with red colour).

Valid measurement ranges:

The program‟s analysis accepts BP values within these ranges. If the results of certain
measurements are outside of this range the software takes the measurements out of the
evaluation and marks them as invalid.

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4.2.6.2 Colours...
In this window, you can create your own custom colour
schemes for the Cardiospy‟s looking or you can use the
default ones. The default schemes cannot be modified.
You can set the colour of the windows and menus
separately by any way you want, since you can change
almost every element of the software (like curves,
background, ruler, QRS mark, etc.)
4.2.6.3 Continuous playing...
It is possible to modify the speed of continuous playing of the Holter ECG records.
Setting>continuous playing menu>select the proper speed from 1 to 9.

You can play the record with this button next to the scrollbar at the middle of the screen.

4.2.6.4 Automatic analyzing after read

There are 3 options that you can set here: “Never”, “Ask every time” and “Always”.
Never: If you read in a record from the device, then it will be stored in the database, but
the software is leaving it unfiltered and the analyzing process will not be performed.
Ask every time: If you read in a record from the device, then a prompt window will
pop up every time about if you want to perform the analyzing process or not.
Always: This is the default option. The software will always perform the analyzing
process.

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4.2.6.5 Refresh / Analysis mode...
Apply changes immediately: The software runs the
automatic analysis every time we edit the record,
this way we‟ll see the results on the screen
immediately. This function is only recommended for
modern and fast computers.
Use refresh button: The software does not
run the automatic analysis each time the
record is edited, the analysis only runs when the user presses the refresh button or
change the screen. It is recommended for computers with slow CPU or insufficient
RAM. Refresh button can be found in the middle of the screen, next to the horizontal
slide.

4.2.6.6 New analysis

With this menu point, you can run a new analyzing process. It is useful when you have a
record that was not analyzed before, you have updated the Cardiospy from an old
version recently or you want to start the measuring from the start.

BE CAREFUL, THE NEW ANALYZIS WILL DELETE ALL OF YOUR

PREVIOUS CHANGES THAT YOU HAVE MADE MANUALLY!

4.2.6.7 Service
In this window, you can see information about the
device that was used for the current record. You can see
the device type, recorder version, recorder serial
number, Bluetooth module version, story capacity, total
number of records that was made with the device,
uptime (total time of usage), previously defined
sampling frequency and the current software version (if
you have made the current record in an older version of
Cardiospy, you will see its version number as well).
4.2.6.8 Control panel...
You can also open the Control panel, just like at the main screen (patient database). You
can read more about the control panel in the Cardiospy Installation and Update
Guide.

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5 Print and export

5.1.1 Parts of the Print view

1. You can select the pages for printing by tick or untick the checkboxes next to
the name of the pages.
2. You are able switch between the pages that you want to see with the radio
buttons next to the name of the pages.
3. It is possible to type in the name of the doctor who is requested the
examination and who signed the report.
4. With this checkbox you can hide the personal data of the examined patient,
making the report anonymous.
5. Here you can select the printer you want to use from the list. First you have to
set the printer in Windows to be able to choose it from here.
6. General printer settings. Number of copies, orientation, etc.
7. Print view settings. More in the next chapter.

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5.1.2 Print view settings

General tab (only ABP related options):
1. Enable logo: You can hide the logo
from the header of the report.
2. Enable last modified by: If you have
the “Report” page available, then you
can make it visible or you can even
hide it from the page.
3. Quality: You can set the quality of the printing to low or high graph resolution.
You can set to print in raster or vectorgraphics mode.

“The major difference is that raster image pixels do not retain their appearance as size increases - when you
blow a photograph up, it becomes blurry for this reason. Vector images do retain appearance regardless of
size, since the mathematical formulas dictate how the image is rendered.”

4. Colour mode: You can print in coloured and in black and white mode.

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METHODS

6 Calculation and Evaluation methods

6.1 General calculation methods
Pulse Pressure:
Medium Arterial Pressure:

Diurnal Index:

Where Data: Sys, Dia.

Hyperbaric Impact:

where Datai: Sysi, Diai

Normi = the normal value related to the measurement (in Settings)
Timei = the represented time of the measurement

where Ti = the time of the measurement

Double Product:
Double Product = Sys*HR

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Dipper Status:

Meaning:

Dipper Dipper Status

<0 Reverse Dipper

0-10% Non-Dipper

10-20% Dipper

>20% Extreme Dipper

6.2 Morning Surge

Morning Surge is medically defined as the difference in systolic blood pressure during
the first two hours after awakening and the lowest level recorded during the day. The
greater the difference the more likely is the risk of stroke.
(Article Source: http://EzineArticles.com/3086388)
AASI (Ambulatory Arterial Stiffness Index)
AASI=1-Slope
where Slope = Diastole – Systole graph (Scatter) steepness of the regressive line.

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MAINTENANCE

7 Troubleshooting and maintenance

7.1 Sending a bug report
Creating Blackbox:
After the installation you can find a Generate black box shortcut under the Start Menu /
Labtech / Cardiospy/. You can also reach this window from the Cardiospy, if you go
into the Help / Bug report... menu.
Please fill the description based on your experiences with as much info as possible.
If you are ready to send us the bug report, then you can do it two ways.
1. If you click on the “Send” button, then the bug report will be automatically
registered in our Issue Tracking System (Jira).
2. If you chose to save the blackbox file, please send it to our e-mail address.
([email protected])

If you have problem with the recorder (you cannot read in for example), then connect
the device to the PC and tick the “Memory content” checkbox.
If you exported the record files that you have problem with, you can attach them to the
bug report by ticking the “Select records or other files” (like screenshots).

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You can make screenshot with the Print Screen button, then import it to Paint with
CTRL+V and save the file. The screenshots are important in that case you got an error
message or to show in the record where you have problem with it.
7.2 Calibration and maintenance
7.2.1 Calibration
Calibration of the ABPM (blood pressure) has to be carried out from time to time as
prescribed by the relevant standards. To ensure calibration is performed according to the
relevant standards, please return the device to Labtech Ltd. where we will perform
calibration free of charge.
The accuracy of controls is assured by using long lasting parts and techniques that are
able to preserve their accuracy during the life cycle of the product.
7.2.2 Maintenance
Inspect every cable, pneumatic hose and the monitor case for cracks or fraying before
each measurement. Do not use the monitor in case it shows any sign of damage.
The case of the recorder unit may be cleaned or washed if necessary. Do not immerse
the monitor in any fluid, or attempt to clean with liquid detergents, cleaning agents, or
solvents.
The quality of the batteries declines with time: it is recommended to switch to new ones
after 6 months of usage.
Cleaning of the device
Do not dip the device in liquid, for cleaning the device use moistened wipes with a
moderate acting (not aggressive) disinfectant or cleaning agent. Liquid getting inside of
the device can cause electric failures!

Cleaning of the Blood Pressure cuff

First, remove the rubber tube and to clean the textile cuff.
Wipe or wash the cuff with moistened wipes with a moderate acting (not aggressive)
and temperature (max. 30 °C) disinfectant or cleaning agent. Dry on room temperature.

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8 Technical specifications

BP measurement Oscillometric with step deflation, Diastolic values

method: correspond to Phase 5 Korotkoff Sounds

BP measurement range: 25 – 260 mmHg (max inflate 300 mmHg)

Pressure Transducer
± 3 mmHg
Accuracy:

Pulse Rate Range: 30 – 220 BPM (Beats Per Minute)

Pulse Rate Accuracy: ± 2% or ±3 BPM, whichever is greater

Calibration: The device should be verified on a yearly interval.

Max. inflation pressure is limited to 300 mmHg;

Auto safety release valve for power failure.
Safety Systems: Maximum cuff inflation time is limited to 75 seconds.
Duration of blood pressure reading is limited to 130
seconds.

Data Connector: Mini USB mini-B type connector

2 x 1.2 V AA rechargeable batteries of minimum

Min. Power supply: 2500 mAh capacity or 2 x 1.5V AA high quality
alkaline batteries

Size: Approx. 125 x 70 x 33 mm

Weight: Approx. 250 g (incl. Batteries)

Meets accuracy requirements of ANSI/AAMI

Clinical Accuracy:
SP10:2002(R)2008, EN1060-4:2004 and ISO
81060-2:2009.

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