Galix WinTer Holter Analyzer User`s Manual

Galix WinTer Holter Analyzer User`s Manual
Galix WinTer
Holter Analyzer
User’s Manual
2555 Collins Avenue, Suite C-5, Miami Beach, FL 33140, U.S.A.
Tel.: (305) 534-5905 Fax: (305) 534-8222
INDEX
1 – INTRODUCTION .............................................................................................................................................................4
1.1 – CORRECT ELECTRODE PLACEMENT ...............................................................................................................................4
1.2 – HARDWARE REQUIREMENTS ..........................................................................................................................................5
2– SCREEN HIERARCHY ....................................................................................................................................................6
3 – OPENING THE HOLTER ANALYZER SOFTWARE ................................................................................................7
3.1 - SCREEN CONFIGURATION ...............................................................................................................................................7
4 – MAIN MENU.....................................................................................................................................................................9
4.1 – TOOLBAR OPTIONS ........................................................................................................................................................9
5- CONFIGURATION MENU .............................................................................................................................................12
5.1 - PHYSICIANS/INSTITUTION INF. FILE FOLDER ................................................................................................................13
5.1.1. - New Institution ....................................................................................................................................................13
5.1.2 – Delete Institution..................................................................................................................................................14
5.1.3 – New Physician .....................................................................................................................................................15
5.1.4 – Delete Physician ..................................................................................................................................................16
5.2 – PHYSICIAN CONFIGURATION FILE FOLDER ..................................................................................................................17
5.3 - DATA SOURCE FILE FOLDER .........................................................................................................................................18
6 – PATIENT HOOK UP......................................................................................................................................................21
6.1 – PATIENT INFORMATION................................................................................................................................................22
6.2 – OPTIONAL DATA ..........................................................................................................................................................23
6.3 – CANCELING MEMORY CARD IDENTIFICATION ...............................................................................................................23
6.4 – COMPLETING MEMORY CARD IDENTIFICATION .............................................................................................................23
6.5 - FILE CONTAINING THE CURRENT PATIENT INFORMATION ..............................................................................................24
7 – NEW PATIENT ...............................................................................................................................................................25
7.1 – PATIENT DEMO ............................................................................................................................................................25
7.2. - AUTOMATIC DATA UPDATE ..........................................................................................................................................26
7.3 – PATIENT INFORMATION................................................................................................................................................27
7.4 – ECG SIGNAL DECOMPRESSION .....................................................................................................................................27
7.5 - EXISTING PATIENT ........................................................................................................................................................27
7.6 - EXISTING PATIENT STUDY .............................................................................................................................................28
7.7 - MORE THAN SIX STUDIES PER PATIENT .........................................................................................................................28
7.8 – CLOSING THE CURRENT PATIENT FILE ..........................................................................................................................29
8 – ECG STRIPS PRE-ANALYSIS .....................................................................................................................................30
9 – ECG STRIPS POST-ANALYSIS...................................................................................................................................33
9.1 – EIGHT-SECONDS AND ONE-MINUTE GRAPHS .................................................................................................................33
9.2 - STORING STRIPS ............................................................................................................................................................35
9.3 – CHANGING THE STRIP LENGTH .....................................................................................................................................36
9.4 – PRINTING STRIPS ..........................................................................................................................................................37
9.5 - INTERVAL MEASUREMENT ...........................................................................................................................................37
9.6 – CHANGE BEATS CLASSIFICATION .................................................................................................................................38
9.7 – PACEMAKER ANALYSIS ...............................................................................................................................................39
10 – TWENTY FOUR HOURS STATISTICAL GRAPHS...............................................................................................41
10.1 – MINUTES NOT ANALYZED ..........................................................................................................................................41
10.2 – HEART RATE AND TACHOGRAM ................................................................................................................................41
10.3 - DETAILED VIEW .........................................................................................................................................................42
10.4 - ST-SEGMENT DEVIATION ...........................................................................................................................................42
10.5 – QT INTERVAL VALUES ..............................................................................................................................................43
10.6 – VENTRICULAR ECTOPICS (VE) PER HOUR ..................................................................................................................43
10.7 – SUPRAVENTRICULAR ECTOPICS (SVE) PER HOUR ......................................................................................................44
11 – FULL DISCLOSURE....................................................................................................................................................45
11.1 – FULL DISCLOSURE SCROLL COMMANDS ....................................................................................................................46
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11.2 – FULL DISCLOSURE EDITION COMMANDS ...................................................................................................................46
12 – ARRHYTHMIA MORPHOLOGIES ..........................................................................................................................48
12.1 – TEMPLATES ................................................................................................................................................................48
12.2 – EDIT MORPHOLOGIES .................................................................................................................................................49
12.3 - SAVE CHANGES ..........................................................................................................................................................50
13 - MORPHOLOGY CATEGORIES ................................................................................................................................51
13.1 – BEATS ........................................................................................................................................................................51
13.2 - CHANGING THE CURRENT BEAT ..................................................................................................................................52
13.3 – DETAILED VIEW OF THE BEAT ....................................................................................................................................54
13.4 – CHANGING THE BEAT LABEL ......................................................................................................................................54
14 – SIGNIFICANT EVENTS..............................................................................................................................................56
15 – SIGNIFICANT EVENTS EDITOR .............................................................................................................................58
16 – HEART RATE VARIABILITY ...................................................................................................................................60
16.1 – TIME DOMAIN ANALYSIS ............................................................................................................................................60
16.2 – FREQUENCY DOMAIN ANALYSIS .................................................................................................................................61
17 – HOURLY TABLE .........................................................................................................................................................67
18 – RETAINED STRIPS .....................................................................................................................................................70
19 – PRINTING REPORTS .................................................................................................................................................71
20 – RETRIEVE STORED PATIENT INFORMATION..................................................................................................76
20.1 – STORE PATIENT FILES .................................................................................................................................................76
20.2 – STUDY SELECTION .....................................................................................................................................................78
21 – ERASE PATIENTS .......................................................................................................................................................79
22 – STORE PATIENT INFORMATION ..........................................................................................................................80
23 – MORE THAN 24-HOURS RECORDING ..................................................................................................................82
24 - WARRANTY..................................................................................................................................................................83
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1 – INTRODUCTION
The continuous monitoring of ECG signal over a 24-hour period is a powerful tool for a thorough
evaluation of a cardiac patient, both in hospital and ambulatory environments. The Holter study
should only be performed on a patient when prescribed by a physician.
In this section we describe the main characteristics of the Galix WinTer Holter analyzer program.
The program has been designed to offer the user all the tools necessary to perform advanced
Holter analysis while maintaining communication with the user in simple and easy terms.
The Holter analyzer program allows:
™ Storage of as many complete Holter studies as the particular hard disk allows. As a
reference, each 24-hour Holter study takes 34 Mb of disk space.
™ The storage of Holter reports in the hard disk.
™ A maximum of 6 Holter reports or complete Holter studies per patient can be stored in the
hard disk.
™ Analysis of 3-channel Holter studies by measuring the ST-segment deviations, the QT
interval, ventricular ectopics, supraventricular ectopics, etc.
™ The deactivation of one of the three channels for analysis. This feature is valuable in order
to obtain a good Holter analysis even when one of the channels is noisy.
™ The evaluation of arrhythmias and the possibility to edit morphology classifications.
The Galix Holter Analyzer program provides a series of tools that enable a better reading of
electrocardiographic studies. These are: Automatic Detection and Classification, Supervised
Detection and Classification Page Scans.
1.1 – Correct Electrode Placement
This is the most important phase in acquiring the 3-channel ECG signal during a 24-hour period.
The most important issue to obtain a good quality ECG tracing is a proper electrode placement
technique. This is essential in order to reduce the recording of artifacts and poor quality baselines.
ELECTRODE PLACEMENT
5 LEAD
3 CHANNEL
5 LEAD
2 CHANNEL
F10 -
5 LEAD
7 CHANNEL
Blue
Brown
White
White
Red
Brown
Black
Green
Orange
Black
White
Red
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Brown
Black
Operation Manual
Green
Red
4
To obtain clean ECG tracings, it is recommended that the patient is shaved in the area where the
electrodes will be placed. Electrode sites should be clean, dry and free of any residue. If oils,
liniments or lotions have been used in the patient’s care, alcohol will be required to remove the
residue. When alcohol is used, allow the sites to dry completely
1.2 – Hardware Requirements
The only hardware requirement is a recent PC with a Windows operating system. Nevertheless, the
more up-to-date the PC is, the better the Holter or ECG analysis will be. “Up-to-date” refers to the
capacity of the hard disk, RAM size, video card resolution, and microprocessor speed. All these
upgrades will enable the user to obtain greater speed in the calculations and an optimization in the
presentation of graphic displays. Similar arguments apply to the printer, which we recommend be a
laser one.
Before loading any supporting or informative programs, the user should contact Galix Biomedical
Instrumentation or an authorized representative.
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2– SCREEN HIERARCHY
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3 – OPENING THE HOLTER ANALYZER SOFTWARE
To open the Holter Analyzer Software, click on the Start button of the Windows Bar and then
select: Programs > GBI Holter > GBI Holter.
Alternatively, you can double click on the Holter icon located on the Windows Desktop
3.1 - Screen Configuration
Initially, the program will automatically control the screen configuration. In case the user does not
find the following recommended configuration:
1024 x 768 large pixels
Appearance: Standard Windows
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The following message will appear:
When the option “OK” is selected, the user should manually modify the screen configuration
before the program continues.
If the user chooses to cancel the action, the system will continue with the program.
Next, the main menu will appear. From now on, we will refer to this screen as the “Main Menu”.
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4 – MAIN MENU
From the main menu the following options are available:
4.1 – Toolbar Options
Connect: Allows the identification of each memory card containing the patient data before
recording the 24-hour ECG signal. If desired, this option enables the “Patient Diary” printing.
New: Decompresses and analyzes the ECG recordings stored in a “memory card.”
Open: Allows visualization of the analyzed studies in either summary form (about 400 Kb) or
complete form (34 Mb) or studies that have only being retained.
Retain: Decompresses the ECG signal recorded, but does not analyze it.
Exit:
This option is used to quit the program.
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Demo: Run this option to process a demo signal in order to start getting familiarized with the
program.
To process the demo signal, click the demo icon located in the Main Menu toolbar.
The program will enter the “New Patient” screen (explained in section 7) with the demo patient
information.
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To start analyzing the demo signal press the following icon:
VLP: Enables the Ventricular Late Potential analysis module. For more information please refer to
VLP operation manual.
Electrodes: This option offers a visual help for the correct placement of the electrodes. To
access, click the following icon located in the Main Menu toolbar.
The program will open the following file:
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5- CONFIGURATION MENU
Features
All the necessary parameters for the system to analyze the ECG signal according to the user’s
needs are set up here.
Entering the Configuration Screen
With the left button of the mouse click on the icon shown below located on the Toolbar of the Main
Menu.
The program will display the following screen:
Menus
Icons to add and
delete institutions
Stored
institutions
Icons to add and
delete physicians
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This window contains three file folders:
Physicians/Institutions Information
Physician configuration
Data Source
5.1 - Physicians/Institution Inf. File folder
This file folder contains:
A - “Institution Information”: Information corresponding to those institutions which have already
been stored in the database.
Institution: Name of the clinic, hospital, etc. This name will appear as a header in the Holter
Summary Report and the Patient Diary. Clicking on the arrow found on the right of the control will
display the institution names in alphabetical order.
Address: Address of the selected institution.
Telephone: Phone number of the selected institution.
Fax: Fax number of the selected institution.
B - “Physician Information by Institution”: Information of the physicians belonging to each
institution.
Last Name: Last name of the physician who will analyze the study for the selected institution in
the upper quadrant. If the user clicks on the arrow to the right of this control he/she will note that
all the last names of the selected institution’s registered physicians are found in alphabetical
order.
Name: Physician’s name
Address: Physician’s address
Telephone: Physician’s phone number.
Fax: Physician’s fax number.
5.1.1. - New Institution
In the Institution Information panel located in the “Inf. Physician/Institution” folder you can find
the following icon:
When clicking on this icon the lower part of this window is deactivated to allow the user to
complete only the data of the new institution. In addition, the inscriptions on the icons are
changed allowing the user to update the changes introduced by clicking on the save icon.
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Icons to save or
cancel changes
Deactivated
section
Every time an institution is added, the system will automatically add a physician by default called
“Test Physician”. This field cannot be eliminated since each institution should have at least one
physician, but can be renamed.
Once the information has been entered, click on the “Save” button to store the data into the
database or cancel this operation by clicking on “Cancel”. The system will not save any changes
unless the institution’s name is entered. When trying to save a file without the institution’s name
the following message will appear:
5.1.2 – Delete Institution
In the Institution Information panel the icon Delete can be found:
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Once one of the existing institutions is selected, the user should click on this icon in order to
delete the selected institution.
If the user selects the “Yes” option, the Institution will be removed as well as all the physicians
related to that Institution. If the “No” option is selected no change will take place.
5.1.3 – New Physician
In the Physician Information by Institution panel the following icon can be found:
When clicking on this icon the upper part of the window will be deactivated to allow the user to
complete only the new physician data. In addition, the inscriptions on the icons are changed
allowing the user to update the changes introduced by clicking on the save icon.
Deactivated
section
Icons
to save or
cancel
changes
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Once the information has been entered, click on the “Save” icon to store the data in the database
or cancel this operation by clicking on “Cancel”. The system will not save any changes unless the
physician’s name is entered. When trying to save a file that misses the physician’s name the
following message will appear:
5.1.4 – Delete Physician
In the lower panel of the “Physicians/Institution Inf.” folder the following icon can be found:
Once one of the existing physicians is selected, the user will be able to click on this icon and the
system will request confirmation for deleting the selected physician as shown in the following
screen.
Note: The “Clinic Physician” cannot be eliminated. If the user tries to delete it, there will
be a message saying that this action cannot be performed.
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5.2 – Physician Configuration File Folder
This file folder contains:
Parameter information that the system will consider for detection and classification of the ECG
signal.
Selection of the reports to be printed.
Hours to process: Allows user to choose the processing time. This option is useful when the Holter
study has lasted less than 24 hours, thus saving processing time.
Pause Time: Allows choosing the time, in seconds, that is considered as a pause (absence of a
beat) for a specific patient. If the period between two beats exceeds in seconds the one indicated
in this field, the system will consider it a pause.
SVE Prematurity: Allows setting the percentage at which a beat is considered premature, in order
for the program to classify it as an SVE (Supra Ventricular Ectopic). This option is useful when the
user knows that the patient is experiencing atrial fibrillation. Increasing this percentage to about
40% will eliminate most of the premature beats (atrial fibrillation) of the SVE count.
Print Disabled Channel: This option enables the printing of the disabled channel even though the
signal is too noisy.
Heart Rate Limits: The user must select the desired heart rate which the system will use as heart
rate upper and lower limits.
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Printing: The user can select the type of printing from color to black & white.
Doc & Print: Enables/ Disables the automatic printing of a configurable report.
Report: Pressing on this icon located in the lower left section of the Configuration Menu, will allow
the selection of the pages to be printed in the report.
Select the appropriate boxes in order to include the different pages in the report and press
“Apply” when the selection is completed or “Cancel” if these changes are not desired.
5.3 - Data Source File folder
In this folder, the path which the program uses to find the ECG signal files for analysis can be
found. There are two ways of searching for the data path. The first is automatic and the second is
manual, selected by the user.
Our Digital Holter Analyzer uses memory cards as a recording medium and a memory card reader
as the interface, which can be internal or external to the PC.
Since this method of analysis is conventional among the digital Holters, the system is prepared so
that the analysis takes place in direct form, i.e., with the “Automatic Search” enabled.
Nevertheless, because of the extraordinary advances in data transmission methods, Galix
considered it necessary to program access via alternative methods such as, CDs, fiber optic
transmission, fast internet access, and others. In this case, the user will select the “Manual”
option where the alternative data path can be specified.
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IMPORTANT: If studies are only processed from the “memory card”, the option “Automatic
Search” must be enabled, and the memory card must be placed in the corresponding card
reader.
Automatic Search:
When this option is selected, the system will search in all the units connected to the computer for
the card containing the information for analysis. If the system does not find the unit with the
information, it will ask the user to insert the memory card into the card reader.
File Path for the
compressed
signal
Manual
search of
the disk unit
where
compressed
signal is
stored
Automatic search of the unit
containing the compressed signal
Manual Search
With this option the user manually indicates the path where the information is located. This can be
done by typing the path directly into the space provided or by using the Browse button. When this
button is pressed, a typical exploration window will appear from which the user can select a data
source. Once the folder containing the files is selected, the user should select the “Ok” button.
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Note: Pressing the symbol “+” found in front of each disk unit, allows the user to view all
the folders contained in each disk unit. To select one of these folders, the user should left
click on the one desired and then press the “OK” button.
Confirm or cancel changes
Finally, the user will confirm the changes to update the database by selecting “Apply”. Clicking on
the “Exit” icon will display the following message:
If the user selects “Yes”, the program will save the changes and exit the system. If the user
selects “No”, the program will exit the system without saving the changes. Selecting “Cancel” will
go back to the previous screen.
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6 – PATIENT HOOK UP
Features
Is used to control the proper patient electrode placement before recording the ECG signal.
Enables the identification of each memory card that will be placed in the Galix Holter Recorder
GBI-3SM with a text file containing patient data, prior to carrying out the 24-hour recording.
To provide the patient with the “Patient Diary”, before he or she leaves the physician’s office.
Accessing the screen
To access the “Connecting Memory Card” screen, the user must click on the first icon on the Main
Menu Toolbar.
The Holter analyzer will immediately display the following screen:
Note: the same screen will appear when the user performs one of the following operations:
• Identification of the “memory card”, saving patient data before recording (see “Patient
Connection” screen).
• New patient analysis (see “Patient Connection” screen).
• Retain Patient (see “retain”).
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Screen Information
On this screen, the user will enter the patient data. The user will be able to move from one field
to the next one using the TAB key or with the mouse. There are two sections: Patient Information
and Optional Data.
6.1 – Patient Information
Filling in all these fields is mandatory in order to process the Holter study.
a – Date: This shows the date in which the study was performed. The system will automatically
take the current date from the PC.
Change the current date
The following figure shows a small calendar where the user will be able to alter the date that
appears on the screen. This calendar will appear if the user clicks on the arrow on the right of the
control.
Go to the next
month
Go to the
previous
b - Start time: this time will be stored in the database as the time the Holter recording began.
This data will be taken from the PC. The user will be able to modify these values through the
keyboard, as long as these are numerical values. Otherwise the following message will appear:
c – ID#, Social Security Number or any identification number which is unique to each patient. Only
numbers are allowed in this field. If the user enters letters, periods or any other character, the
system will inform the user that there is an error.
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d – Last Name: Patient’s last name
e – Name: Patient’s name
6.2 – Optional Data
a – Address: Patient’s address.
b – Telephone: Patient’s phone number.
c – Birth date: Patient’s date of birth in month/day/year format.
system will inform the user.
If the date is not valid the
d – Age: If the user entered a valid date the system will automatically calculate the age of the
patient. If this is not the case, then this value can be entered with the keyboard.
e – Sex: The system accepts (F) for female and (M) for male.
f – Weight: The value entered should be in pounds or kilograms.
g – Height: The value entered should be in feet/inches or in meters.
h– Referred by: Name and last name of the referring physician.
i – Physician: Name and last name of the physician who will analyze the study.
j – Indications: Symptoms presented by the patient at the time of the study.
k - Medications: Medications that the patient is currently taking.
6.3 – Canceling memory card identification
The user will be able to exit this screen by clicking on the “Exit” icon located on the left of the
current screen toolbar.
6.4 – Completing memory card identification
Once the patient data has been entered, the user should click on the “Next” icon located on the
right of the Toolbar.
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The program will then:
•
•
Record the patient information on the memory card.
Ask if you want to print the “Patient Diary” that will be given to the patient.
•
Inform the user that the card must be removed and inserted into the GBI-3SM Holter
recorder.
6.5 - File containing the current patient information
If the memory card contains information from a previous patient, the system will ask the user if
the card should be overwritten.
Selecting “Yes” will delete the file and allow a new ECG recording. If the user selects “No”, the
program will go to the Main Menu.
Incomplete Patient Information
If the user does not provide the required patient data in “Patient Information” and still presses the
“Next” icon, the following message will be displayed:
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7 – NEW PATIENT
7.1 – Patient Demo
If desired, the complete operating sequence of the Holter analyzer can be run with a special
program called Demo. This demo program is a valuable tool for learning the operating procedures
and features of the Holter program.
The demo signal can be found in the following directory: C:\GBIHolter\DemoSignal. In this way,
the user can test the system without using a memory card following these steps:
Enter the “Holter Configuration” Menu.
Access the “Data Source” file folder.
Deselect the “Automatic Search” option by clicking on the box.
Press the “Browse” button.
Click (just once) on the + sign located to the left of each subdirectory until reaching the path:
C:\GBIHolter\DemoSignal.
Folder:
C:\GBI\WinTer\DemoSignal
Click on the “OK” icon and exit the Holter Configuration screen.
IMPORTANT: Remember that after testing the system with the DemoSignal, the user must
return to the ‘Holter Configuration” screen to select the “Automatic Search” option, in order for
the system to resume searching the memory card.
Access to New Patient screen:
Features
Used to update the database with the patient’s information and the Holter study data.
Used to decompress the ECG signal.
To process the ECG signal.
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Accessing the screen
Prior to starting, the user must insert the memory card in the card reader, in order for the patient
data to be automatically transferred, assuming that the “Connecting” process has been carried
out. Next, the user must do one of the following:
Left click on the “New” icon located in the Main Menu Toolbar
The Holter system will show the following message:
Then the “New Patient” screen will be displayed.
7.2. - Automatic data update
When this window is opened, the program will search for the patient information file (GBI.PAT). If
the system finds the file in the “Data Path” indicated in the Holter configuration, all the data will
automatically be shown in the corresponding fields on the screen and can be modified by the user
before decompression. In any case, the user must complete at least the fields provided in the
“Patient Information” panel.
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The “Optional Data” panel is not required for the Holter analyzer operation, but is important for
the proper maintenance of the database of the patient to be analyzed.
7.3 – Patient Information
See “Patient Information” in the “Connecting” section.
7.4 – ECG signal decompression
Once the necessary data has been entered, in order to decompress the ECG signal, the user must
press on the “Next” icon located on the right of the Toolbar.
The program then begins to decompress the ECG signal. It will verify that the data found is
correct. If the ECG data is not found the system will show the message below:
In the same way, the system will display other error messages that will not allow the signal to be
decompressed. These are:
The file CRECG.INF could not be created
Missing File ECG.DAT
The file CRECG.DAT could not be created
Incorrect “Data Source” specified
Note: There are three other situations (Missing file GBI.INF; Missing file GBI.SES; The file
GBI.SES cannot be created). Although they do not cause an interruption of the Holter analysis, it
is important to know that these messages have appeared. For this reason, a control file
(CRECG.LOG) is created to report these messages.
If everything is OK, the system will recognize if one of the following options was selected in the
configuration process.
Supervised detection and classification
Page Scan
The screen corresponding to the option selected will appear after the signal is decompressed. If
neither option was chosen, then the “Statistical Graphs for 24-hour period” screen is displayed.
The following describe certain possibilities that may occur during analysis.
7.5 - Existing patient
If a previous Holter study has been done on a patient, entering the identification number or the
patient’s name, will automatically display the rest of the patient’s information.
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7.6 - Existing patient study
Since each ECG recording normally is conducted over a 24-hour period, the system expects to find
only one study per day. Thus, the system uses the ID#, and the date of the study to identify the
patient. If it finds out that there is already a study on that date for that patient, most probably we
are about to make a mistake; for that reason, we are requested to double check this download:
If “Yes” is selected, the system will rewrite the patient data and the Holter study data. If “No” is
selected, the system will remain in the current screen, without modifying the stored information.
7.7 - More than six studies per patient
This system allows a maximum number of 6 Holter studies per patient to be stored in the
database. If the program detects that there are already six studies, it will check if there is
another study with the same date and will ask the user if he/she wishes to overwrite the study
with the message shown previously. But, if a study with the same date does not exist, then the
following message will appear:
If the “No” option is selected, the system will remain on the same screen. If the “Yes” option is
selected, the “Delete Patient Study” window containing all the patient studies will be displayed.
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The patient’s information appears in the upper part of the window. In the lower part all the
studies with their respective dates, processed hours and the physician who performed the study
will be displayed.
The boxes on the left of each study are used to select the studies to be deleted in order to leave
space for the new study.
Once the studies to be deleted are selected, the user must click on the “Delete” icon, and the
system will ask to confirm the studies to be deleted.
Clicking on “Yes” will delete these studies and clicking on “No” will cancel this action and will
remain in the “Delete Patient Study” screen.
If the user wishes not to eliminate any of the studies, the Exit” icon should be selected to return
to the “New Patient” menu.
7.8 – Closing the current patient file
When the user wishes to exit the “New Patient” screen, he/she should click on the “Exit” icon
located on the bottom left corner of the screen.
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8 – ECG STRIPS PRE-ANALYSIS
Features
Lets the user know the parameters the system takes into account when detecting and classifying
the ECG signal.
Allows modification of the parameters (polarity, gain, template, labels, etc) in order to achieve the
best detection and classification of the ECG signal.
Accessing the screen
The user will be able to access the screen after making click on the “Next” button mentioned
before on the New Patient screen. Once the signal has been decompressed, the system will show
the following screen.
Processing
Progress
Button
Bar
+/Gain
Eightsecond
ECG
strips
Switch
Polarity
Scroll
Bar
Change
State
Quality
Channel
Index
Processing Button: Click this button to start processing the ECG signal
+ / - Gain: The system will change the gain of the channel selected as shown in the figure below.
To change press the buttons (+) or (-) as desired.
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Normal
Gain
Gain
decreased
Gain
increased
Switch Polarity: The system will change the polarity of the channel as shown in the following
figure. To change Switch
press Polarity
Inverted
Polarity
Change State: If one of the three channels has excessive noise, the user has the option to
deactivate the channel, and thus, this channel will not be taken into account when detecting and
classifying each beat. Only one channel can be deactivated.
To deactivate press Change State
Deactivated
channel
color
changes
to grey
Channel quality
The first graph below shows the “Quality Index” for each channel.
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Each channel will be identified by the colors already designated: channel one is pink, channel two
is light blue and channel three is violet.
Quality indexes: from 0 to 100
Hours: from 0 to 24
On both sides of this graph, the user will see the scales that indicate the quality of the recording
in each channel, which ranges from 0 to 100. The closer the tracings are to 0, the higher the noise
and thus, the lower the signal quality, and vice versa. If one of the three channels is deactivated,
that channel’s graph is displayed in gray and has a quality index of 0.
Channel Quality Index
The Channel Quality Index (CQI) is a parameter that estimates the noise content of an ECG
signal. This value is calculated minute by minute and is constant during the chosen minute. B
means of this parameter, the system is able to choose, for each study, the best quality channels
for the analysis, thus improving the analysis results.
The CQI has a temporary sensitivity of approximately 15 seconds, or in other words, the noise has
to be present at least 15 seconds during the minute of analysis to affect the value of the CQI.
This index allows the Analyzer to detect those signal segments, in a particular channel, that could
interfere with the process of beat detection and classification. The CQI is coded with values from 0
to 100 where the higher the value of this index, the higher the signal quality.
Normally, CQI values range from 65 to 80. CQI values that are 40 or less indicate that the signal
is inadequate for analysis. The graphic representation of the CQI allows the user to quickly verify
if the Holter recordings obtained is acceptable in terms of signal quality throughout the study.
By inspecting this index, it is also possible to determine which segments present anomalies due to
different circumstances, such as
If the index decreases in a specific channel, this could indicate a loose electrode or a similar
defect.
If the index decreases simultaneously in all three channels, then the following should be
considered:
• Muscular movements
• Significant heart rate increase
• Problems with the recorder
Once you finished setting up all the previous parameters, click the following button to start
analysis.
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9 – ECG STRIPS POST-ANALYSIS
Features
•
•
•
•
•
Displays 3-channels, eight seconds ECG strips at 25 mm/sec.
Locates the eight seconds strip within the one minute signal displayed.
Stores the strips that will later become retained strips.
Labels the retained strips.
Instantly prints 8, 16 or 24 seconds of the ECG signal.
ATTENTION: If the option “Doc&Print” is selected in the Physician Configuration
screen the following screen will appear.
“Print Reports” screen will be described on chapter 18.
Press Cancel to continue with the analysis without printing at this stage.
9.1 – Eight-seconds and one-minute graphs
On this screen, two important graphs are displayed. The first one contains eight seconds of the
electrocardiographic signal, and the second, the minute that corresponds to these eight seconds.
Beat classification
The beat label will be placed on it.
Each one of the beats detected within the 8-seconds graph, will be labeled as follows:
• Normal beat: marked with a dot
• Ventricular beat: marked with a V
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•
•
•
•
Supraventricular beat: marked with an S
Artifacts: marked with an X
Aberrant: marked with an A
Paced Beat: marked with a P
Heart Rate and R-R Interval
The Heart Rate measured in beats per minute and the R-R Interval in milliseconds are displayed
on the screen between two consecutive beats.
HR/RR
Interval
Eight –
second
ECG
strips
Oneminute
ECG
signal
Eight-seconds ECG strip
In the one-minute graph, the user will see a red frame. This indicates the position within the
minute where the eight seconds are represented.
To change the current eight-seconds ECG strip
The user will be able to use the arrows of the keyboard to move from one side to another of the
minute according to the following scheme:
Å Arrow
Æ Arrow
È Arrow
Ç Arrow
Page up
Page Down
Goes
Goes
Goes
Goes
Goes
Goes
backwards 100 milliseconds in the signal.
forward 100 milliseconds in the signal.
backwards 2 seconds in the signal.
forward 2 seconds in the signal.
forward 1 minute in the signal
backwards 1 minute in the signal
Also, the same action can be accomplished by using the scroll bar located under the 8-second
signal graph.
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Advances 8 seconds
Backs down 8
seconds
Backs
down by 1
Button: goes backwards
and forward
1-second
increments
Another way to change the current 8 seconds is by clicking in any place of the one-minute signal.
The user clicked this point
Current time
On the left of the screen, between the two graphs, the time is displayed in Hr:Min:Sec format.
9.2 - Storing strips
The user will be able to store up to 32 eight-second strips. Each one of these strips will be saved
with the following information:
•
•
•
•
Strip label
Classification of each beat
Heart Rate between two beats
R-R Interval between two beats
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The number of strips to save or to print will be determined by the size of the red panel in the
current minute graph. According to user needs, 8, 16 or 24 meaning 1, 2 or 3, 8-seconds strips
can be saved or printed (see Changing Strip Length). All the stored strips can be viewed from the
Retained Strips screen.
To save strips, the user must click on
The following screen will appear:
Then, the user will be invited to add a label to this strip. Once this is done the program will
instantly store the strip on disk.
9.3 – Changing the strip length
The length of the strip refers to whether the strips will be saved or printed in strips of 8, 16 or 24
seconds. By default the length is 8 seconds.
To change the length, the user should click on the following icon:
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In the first graph of the 8-second screen, only the first eight seconds of the minute displayed on
the graph will be shown.
Strip length: 24 seconds (3 strips of eight seconds each one)
If, for example, at the moment of saving a 24 seconds strip, the user gives it a label, the same
will be applied only to the first 8 seconds strip, while the remaining two strips will be unlabeled.
9.4 – Printing Strips
The user will be able to instantly print the ECG strips from the screen. The quantity of strips to be
printed depends on the selected length (see Changing Strip Length).
Clicking on Print Strip will begin printing the amount of ECG strips indicated by the user.
9.5 - Interval Measurement
When selecting the Cursors button, two vertical bars will appear on the 8-seconds strip screen
that will allow us to measure time intervals.
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The user can select any of the cursors by clicking on it. Once selected, the cursor can be moved
along the strip by dragging it with the mouse (left button kept pressed) or by means of the
horizontal arrow keys.
The following screen will show us both bars being selected the left one. Notice that a new box
appears displaying the time interval measured in milliseconds between the two bars.
Cursors
Time interval between bars measured
If you double-click the box, the reading will change to heart rate.
If you don’t have the cursors available, you can click on any sector of the screen and it will display
the exact time at that point, as shown in the following figure.
9.6 – Change beats classification
This function is used for the edition of beats; you can add, delete and re-classify any beat you
want.
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To change a beat classification, the user must right click on it and select one of the options
displayed in the menu. The options are:
•
•
•
•
•
•
•
•
Normal
Ventricular
Supraventricular
Aberrant
Artifact
Paced
Delete beat
Add beat
A dot indicates a normal beat and an X indicates of an artifact.
9.7 – Pacemaker Analysis
When recording a study with the GBI-3SM Holter recorder, you can detect implantable pacemaker
pulses. To visualize the pacemaker spikes recorded click on the following button:
The screen will look like this:
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10 – TWENTY FOUR HOURS STATISTICAL GRAPHS
Features
It provides a quick gauge of the recording quality of each one of the channels.
It displays, in a single screen, the heart rate variations, the ST segment deviation, the QT interval
and the hourly ventricular and supraventricular ectopics during the 24-hour recording period for
each channel.
Accessing the Screen
•
•
Pressing the next button if you are in ECG strips screen.
Pressing the Trend Graphics button.
HR and
Tachogram
ST values
for each
channel
QT
values
VEs per
hour
SVEs per
hour
10.1 – Minutes not analyzed
The first minutes, which by default are not analyzed, will not be included in the graphs.
10.2 – Heart Rate and Tachogram
In the first graph displayed on the screen, the user is able to switch between Heart Rate and
Tachogram graphs. By default when this screen is first displayed the graph will represent Heart
Rate minute by minute, but by clicking on the “Tachogram” icon, the representation can be
changed. When accessing the Tachogram curve, the R-R interval variations, measured in
milliseconds are plotted minute by minute.
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To return to the Heart Rate graph, the user should select the HR icon.
Note: The Tachogram and HR icon disable each other, depending on which graph type is
selected
10.3 - Detailed View
The user will be able to navigate throughout the entire Heart rate or Tachogram graphs searching
for a specific minute using the keyboard or the mouse. With the keyboard:
•
Up arrow key: moves the cursor 10 minutes to the right.
•
Down arrow key: moves the cursor 10 minutes to the left.
•
Left arrow key: moves the cursor 1 minute to the left
•
Right arrow key: moves the cursor 1 minute to the right.
Current minute indicator
Current minute pointed with the red
Once the cursor is positioned, the corresponding ECG signal can be accessed by double clicking on
the cursor, or by pressing the Enter key.
10.4 - ST-Segment Deviation
The ST segment deviation (mV) of each channel is automatically measured with respect to the
isoelectric line, as seen in the Heart Beat figure below:
PQ segment
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The user can easily identify each channel either by its color code, or by means of the channel
indication, on top of the ST trend graph, as shown below:
Current channel
Pink: Channel 1
Light Blue: Channel 2
Violet: Channel 3
ST-segment value
Hours: from 0 to 24
To see the 24-hour ST trend of a different channel the user must click on the channel icon:
If one of the three channels has been deactivated, the ST-deviations for that channel will be
plotted in gray.
Calculation: To calculate the ST-segment deviation, first of all, the QRS peak, isoelectric baseline
and J point are located. The ST-segment is then calculated as the amplitude of ECG signal 60
milliseconds after J point.
10.5 – QT Interval Values
The QT interval (in milliseconds) is measured from the beginning of the Q wave to the end of the
T wave. The end of the T wave is determined as a function of the maximum value of the filtered
signal after the peak of the T wave. The QT interval stored and presented on the screen is the
maximum of the three derivatives for each beat.
QT Interval indexes
Hours: from 0 to
10.6 – Ventricular Ectopics (VE) per hour
This bar graph represents the ventricular ectopic beats detected per hour.
Plot X: 24 hours
Plot Y: VE (Ventricular Ectopic Beats) per hour, with automatic scaling
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10.7 – Supraventricular Ectopics (SVE) per hour
This bar graph represents the Supraventricular Extopics detected per hour.
Plot X: 24 hours
Plot Y: SVE (SupraVentricular Ectopics) per hour, with automatic scaling
To Exit and Record Patient Data
If the user wishes to exit the Main Menu from this screen, the “Exit” icon must be selected.
The system will prompt the user to confirm the action.
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11 – FULL DISCLOSURE
Features
It displays the 24-hours of ECG signal recorded of a specific channel in a 20-minutes per page
format, in order to show the user the quality of the signal stored as well as its content.
Accessing the screen
•
•
From the Trends Graphics screen, by clicking on Next
By clicking on the full disclosure button.
Screen Description
This screen contains a total of 20 lines, each one of them displaying one minute of ECG signal;
therefore, each scan page displays 20 minutes of the recorded signal. The real time (hh:mm) for
each line is shown on the left of the screen.
Changing the current channel
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To change the current channel, simply click on the the corresponding channel button. If the user
clicks on the Ch. 1-2-3 button, all three channels are displayed, in a 10-minutes-per-screen
format.
11.1 – Full Disclosure Scroll Commands
The Full disclosure toolbar allows the user to scroll the ECG display either automatically or
manually.
By clicking on the Up/Down arrows, the full screen will scroll backwards/forward automatically. By
repeatedly clicking on these arrows, the scrolling speed will change.
By clicking on the Pause command (the one between the vertical arrows), the scrolling will stop.
The Left/Right arrows will make the display to skip to the previous/next page.
11.2 – Full Disclosure Edition Commands
Some of the most important features available at the Full Disclosure section are the abilities to:
•
Access the normal 8-seconds, 25 mm/seg. display of any beat, by simply double clicking
on it on the full disclosure screen.
•
Re-classify any beat directly from the full disclosure screen, by right-clicking on it. The
usual re-classification pop-down menu will appear, where the user can perform the proper
selection
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•
Mark a chain of beats, and re-classify all of them in a single step. By holding the mouse left
button pressed and moving the mouse, the user will draw a red frame on the Full
Disclosure screen. Then, by right-clicking on any point inside the frame, the reclassification pop-down menu will appear. Then, when the user selects one menu option,
all beats inside the frame are re-classified under that category.
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12 – ARRHYTHMIA MORPHOLOGIES
Features
•
•
It identifies all the templates detected by the system for each channel.
The user can change the template labels at will.
Accessing the screen
•
•
From the Full Disclosure screen.
By clicking on the Morphologies button in the toolbar.
Current template,
blue background
Template`s label
Amount of beats
associated to the template
12.1 – Templates
Templates refer to each one of the possible groups that are formed from similar beats. If one of
the beats has been grouped with a template from channel one, it will not be associated with any
of the templates of the other two channels. Thus, if a template in channel 1 is changed from VE1
to normal, there may still be a VE1 template in channels two and three. Every template for every
channel is independent from those in other channels.
The label corresponding to each template and a number representing the number of beats
associated with each template are shown below every template. If the label for a template is
changed then all those beats are re-classified.
Templates will have one of the following labels:
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Normal
The system may detect more than one normal template.
It may happen that one of the channels does not have a normal template. This will only occur if at
least one of the other channels has a Normal template detected by the system
Label: white dot
VE
These are templates which differ from the Normal template and which are less frequent than the
Normal
The user will be able to find a maximum of 7 categories of VE beats
Labels: VE
SVE
These are beats that do not differ substantially from a Normal template, and their incidence is
very low.
The system does not classify premature SVE templates.
The system classifies beats as premature SVE, but not in its template analysis
Label: S
Artifact
These are beats that the system is unable to classify.
Label: A
12.2 – Edit morphologies
The user is able to view in more detail all the beats that form a template. To do this, the user
should select any template and then:
Press the Edit icon or
Press the ENTER key or
Double click on the template.
Once this is done the system will display the “Arrhythmia Morphology Categories” screen (see
Morphology Categories screen).
Change the label of a specific template
All the templates are labeled by the program. Nevertheless, the user might disagree with one of
the labels and he can change it by selecting the template and then pressing the Reclassify button.
Once this is done, the system displays the following screen:
Once the new template label has been selected, the user will accept this change, by pressing the
Accept button and the small window will disappear. If the Cancel button is pressed the small
window will disappear without any changes.
Deactivated channel
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If a channel has been deactivated, the file folder will also show all the deactivated templates and
if selected, the Edit and Label icons on the toolbar will be deactivated as shown in the following
figure.
12.3 - Save changes
If the user has made some changes and has not selected the Apply icon and wishes to do one of
the following:
• View the beats that have been associated to a particular template
• Exit the screen to see the Significant Events (Next) or the 24-hour Statistical Graphs
(Previous).
The system will then ask if he/she wishes to save the changes.
Important: the user must take into account that changes made on this screen will affect the 24hour statistical graphs, the significant events already calculated and the heart rate variability.
Therefore, the user must be very careful with any modifications. We suggest that changes be
made in the order of appearance of these screens: first Morphologies, then Morphology
Categories and finally Significant Events.
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13 - MORPHOLOGY CATEGORIES
Features
•
It shows a detail of each one of the beats that formed a particular morphology.
•
Displays the eight seconds in which the selected beat can be found.
Accessing the screen
From the Arrhythmia Morphologies screen
13.1 – Beats
For each screen, a maximum of 102 beats (17 columns and 6 rows) will be displayed. The system
will indicate the following:
Channel corresponding to the beats.
Label for this category.
Current channel
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Eight-seconds ECG strips
Six 8-seconds strips (one for each row) are displayed on the left side of the screen. This is where
the selected beat will be graphed. When accessing the screen, the first eight seconds of the first
beats for each row will be graphed by default.
Red circle: Current beat
Current beat
Eight–seconds ECG
strips that contain the
current beat.
13.2 - Changing the current beat
To change the current beat, click on the desired beat or use the arrows on the keyboard.
Å
Æ
È
Ç
Goes back a beat within the row.
Goes forward one beat within the row.
Goes down one beat within the column.
Goes up one beat within the column.
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The 8-seconds ECG strip graph in the left will also change as the user moves from beat to beat.
Change the current beats page
If one of the categories contains more than 102 beats, the Next icon will be activated.
This icon allows the user to move forward through all the pages of the category. Once the Next
icon is selected, the Previous icon will be activated to allow the user to return to the previous
pages if necessary.
Selection Modes
There are three ways of making a selection: Single, Row and All. The first selects a single beat
and is the default mode. The second mode selects a complete row. The third one Selects all beats
in the page.
The figure below shows the screen that appears when choosing to view a row of beats.
In this case, the 8-second ECG strips to the left of the screen will not be modified.
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13.3 – Detailed view of the beat
By double-clicking on a beat, the user will be able to see the selected beat in detail. The beat will
be pointed by a red arrow.
Red Arrow that indicates the current
beat in the morphologies category
To go back to the Morphology Categories screen press the Previous button.
13.4 – Changing the beat label
The user can change the label for a beat or for a complete row depending on which mode is
selected. To make the change the user should select one of the following four icons that appear on
the toolbar:
Depending on which icon is selected, the colors are:
•
•
•
•
Black, if Normal is selected.
Red, if VE is selected.
Blue, if SVE is selected.
Yellow, if artifact is selected.
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Next, a screen showing beats pertaining to a Normal template on which the following
modifications were made is displayed below:
In the selection mode Row the complete row was changed from Normal to SVE.
In the selection mode Beat two beats were modified: the first from Normal to artifact and the
second from Normal to VE.
Actual
Beat
Artifact:: Yellow
VE: Red
Normal
Beat:
Black
SVE: Blue Verde
Save changes
If the user has made any changes on this screen, when exiting, using the Previous or Exit icons,
the program will prompt the user to save the changes made.
If the user selects “Yes” the system will update the corresponding files and the totals next to each
template in the “Arrhythmia Morphologies” screen. If the user selects “No” then no modifications
will be made.
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14 – SIGNIFICANT EVENTS
Features
It enables a quick identification of the significant events and the amount of each type of event.
Accessing the screen
•
•
From the Morphologies screen, clicking on Next button
By clicking on the Significant Events button.
Significant Events organization
The Significant Events are organized in 5 sections, with four subsections each. Most of the names
of the sections and subsections are self-explanatory:
•
Ventricular Events
o Ventricular Ectopic
o V – Tach and Couplets
o Bigeminy V
o Trigeminy V
•
Supraventricular Events
o Supraventriculr Ectopic
o SV Tachycardia and Couplets
o Bigeminy SV
o Trigeminy SV
•
Pause, Apnea, SV Events
o Pause
o Apnea
o ST-Segment+ (ECG with the maximum positive ST deviation)
o ST-Segment- (ECG with the maximum negative ST deviation)
•
HR Events
o Maximum HR
o Minimum HR
o HR Higher than limit (the limit is set up in the configuration menu)
o HR Lower than limit (the limit is set up in the configuration menu)
•
Pacer
o
o
o
o
Events
Pacer Capture (Pacemaker spike detected and beat detected)
Capture Failure (Pacemaker spike detected and beat not detected)
Oversensing
Undersensing
The Significan Events screen looks like the following:
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The user can enter any of the sections by clicking on the corresponding tab, like the
supraventricular events one. The user can enter any of the subsections by clicking on it. The
screen will be as follows:
The user will be able to access any of the ECG strips on screen by double clicking on it.
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15 – SIGNIFICANT EVENTS EDITOR
Features
•
•
It shows in detail each one of the events detected by the system.
It enables the rejection of those events where the user does not agree with the events
detected by the system.
Accessing the screen
From the Significant Events screen.
The Significant Events edition can be performed in two different ways, and the procedure depends
on the type of event to deal with.
Ventricular and Supraventricular Events edition
Ventricular and Supraventricular Events are edited by reclassifying the beats that generate them.
For example, being a Ventricular Couplet, a sequence of two consecutive ventricular ectopic beats,
to delete a V-Couplet from the classification, we should change, at least, the classification of one
of these two beats. This can be done in two different ways:
•
From the Significant Events Edition screen, which shows many different events of the same
nature (see the figure above). On this screen, the user can:
o
Select one or several events and click on the Reclassify Event button. This
procedure will open a pop-down menu from which the user can select the new
classification for the selected events.
Tip for multiple events selection: To select a single event, the user simply has to
click on it: To select the second, third, …, the user has to hold the Control key
pressed and click on them, one by one.
•
o
Click on the Reclassify Page button. In this way, all events on screen will be
selected and the same menu of above will appear for beats reclassification.
o
Click on the Reclassify All button. In this way, all events of this kind are reclassified
with the same procedure as stated above.
From the ECG strip itself (which is accessed by double clicking on any of the events on the
Significant Events Edition screen). The corresponding event is opened and the user can
reclassify anyone or all of the beats that form the event.
NOTE: Performing the reclassification from the Significant Events Edition screen is very fast and
easy. On the other hand, in multiple-beats events (like couplets, triplets, bigeminy and
tachycardia) all beats that form that event receive the same classification. This might not apply to
certain cases, in which the reclassification has to be done from the ECG strip itself, beat by beat.
Pause, Apnea, ST, HR and Pacer Events edition
•
Pause, Apnea, ST, HR and Pacer Events are edited only from the Significant Events Edition
screen. On this screen, the user can:
o
Select one or several events and click on the Reject Event button. This procedure
will discard the selected events from this classification.
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Tip for multiple events selection: To select a single event, the user simply has to
click on it: To select the second, third, …, the user has to hold the Control key
pressed and click on them, one by one.
o
Click on the Reject Page button. In this way, all events on screen will be discarded
from this classification.
o
Click on the Reject All button. In this way, all events of this kind are discarded.
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16 – HEART RATE VARIABILITY
This system provides all the parameters required for analysis of the Heart Rate Variability as
suggested by the European Society of Cardiology and the North American Society of Pacing and
Electrophysiolosy and published in the American Heart Association – AHA magazine “Circulation
1996:93:1043-1065” – Heart Rate Variability, Standards of Measurement, Physiology
Interpretation and Clinical Use.
Accessing the Screen
To access the screen press the “Modules” button and then select HRV.
16.1 – Time domain analysis
The figure below illustrates the type of graph the user will see when entering the Heart Rate
Variability screen. It consists of a histogram representing the time domain analysis of heart rate
variations of the patient.
Cursor
Values
Parameter
The time domain analysis of the HRV is based on statistical methods. A series of RR intervals
(distance from two R wave peaks) is obtained from the ECG recording. From these, only those
intervals related to “normal auricular beats” will be taken into account.
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A series of parameters are calculated based on these RR intervals. These parameters are used to
compare the different patient conditions, such as resting, sleeping, walking, and others with the
purpose of evaluating the activity of the autonomous nervous system.
The parameters that the system provides are the following:
SDNN [msec} Standard deviation of the normal RR interval series. It is an estimate of the Overall
HRV. Given that the Variance is mathematically equal to the total spectral potential, the SDNN
reflects all the cyclical components responsible for the variability in the recorded period. This
variable is dependent on the length of the recording.
Triangular Index Total number of normal RR intervals, divided by the height of the HRV histogram
of all the normal RR intervals, measured in a discrete scale of 7.8125 miliseconds.
(A-Dimensional) This index, which is a geometric method, is not appropriate for short recordings.
The principal advantage of this method is the relative insensitivity to the analytical quality of the
RR series, due to the robustness to errors in the beat classification. It is an estimate of the overall
HRV.
SDANN [msec] Standard deviation of the averages of the RR intervals in 5-minute segments. It is
an estimate of the long-term components of the HRV. This index is an estimate of the changes of
the HRV due to cycles longer than 5 minutes.
RMSSD [msec} Square root of the mean of the sum of the squares of differences between the
adjacent normal RR intervals. It is an estimate of the short-term components of the HRV. This
index is an estimator of the variations of high frequency or short periods in the HRV.
16.2 – Frequency domain analysis
The frequency analysis is based on applying the Fast Fourier Transform or FFT. The RR signal is
converted to Heart Rate (HR), linearly interpolated and graphed in regular intervals of 0.5 seconds
(2Hz). This way, 288 segments that represent 5-minute HR signals are obtained. Each one of
these segments is multiplied by a Hanning window to correct the frequency run-ins due to signal
truncation.
On the tool bar of the Heart Rate Variability screen the user can observe two buttons that
correspond to the short-term and long-term frequency analysis.
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Short term Heart Rate Variability – STHRV
Clicking on the icon below, the program will display the short term frequency domain analysis.
The screen that is shown below corresponds to a spectral density analysis (Power Spectral Density
– PSD) of the 5-minute segments described earlier. The following parameters are calculated for
each of these segments.
Total Power [msec2]: Power between the ranges < 0.4 Hz (It is correlated with the RR variance
in the segment)
VLF [msec2]: Power between the ranges < 0.04 Hz
LF [msec2]: Power between the ranges 0.04 – 0.15 Hz
HF [msec2]: Power between the ranges 0.15 – 0.4 Hz
Heart Rate
Spectral
Density in
the current
interval
LF/HF
Ratio
5-minute
current
interval
Spectral Densities
The spectral densities, graphed on the right of this screen, and the central frequencies
corresponding to the peaks present on each of the listed parameters, are not fixed and can vary in
relation to the changes in the autonomous modulation of the cardiac cycle.
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Long Term Heart Rate Variability – LTHRV
Clicking on the icon shown below, the system will display the screen with the long-term frequency
domain analysis.
On the screen shown below there are two graphs.
Spectrum of the 24-hour record of normal RR intervals – Average of all the 5-minute spectrums (graph to the right of the screen). This result includes one ultra low frequency or ULF component
also mentioned in the short-term analysis. Parameters calculated over this spectrum are the
following:
Total Power [msec2]: Power between the ranges < 0.4 Hz
ULF [msec2]: Power between the ranges < 0.003 Hz
VLF [msec2]: Power between the ranges 0.003 – 0.04 Hz
LF [msec2]: Power between the ranges 0.04 – 0.15 Hz
HF [msec2]: Power between the ranges 0.15 – 0.4 Hz
ALFA: slope of the linear interpolation of the specter in logarithmic scale in the < 0.4 Hz range.
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Lorenz Graphic
To watch Lorenz graphic press the following button:
Spectrum on logarithmic scale (graph on the right of the screen). The slope of the spectral curve
on logarithmic scale is another of the available parameters. This one is derived from the 1/f
(infinity symbol) that represents the 24-hour PSD and is associated with non-linear phenomena
present in biological systems, but there is not enough information available on this subject.
The system calculates each graph averaging the 288 spectrums previously obtained.
Summary and Recommendations for the interpretation of the HRV frequency domain analysis
Vagal activity is responsible for HF. There are controversies with respect to the LF components,
some studies suggest that the LF (expressed in normalized units) is a quantitative marker of the
vagal and sympathetic modulations, and thus, some scientists consider the coefficient LF/HF as a
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mirror of the balance between the sympathetic and parasympathetic systems. The interpretations
of the low frequency components, VLF and ULF have not been completely figured out.
Clinical Utility of HRV
Even though, HRV has been the subject of numerous clinical studies, only a general consensus
was reached on the clinical utility of HRV in two scenarios. A decrease in HRV can be used as a
risk predictor after an Acute Myocardial Infarct, and as an early warning signal for diabetic
neuropathy.
Risk Assessment after Acute Myocardial Infarct (AMI)
The observation that in patients with AMI, the absence of respiratory arrhythmias is associated
with an increase in intra-hospital mortality rate represents the first of a long series of reports that
have demonstrated the prognostic value of the HRV for the identification of high-risk patients.
Decrease in HRV is a powerful predictor of mortality and arrrhythmogenic complications, such as,
Sustained Sympathetic Ventricular Tachycardia, in patients after a myocardial infarction. The
predictive value of the HRV is independent of other factors established for the stratification of
post-infarct risk, such as, decrease in left ventricle ejection fraction, increase in ventricular ectopic
activity and presence of late potentials. For the prediction of any cause of mortality, the value of
the HRV is similar to the left ventricle ejection fraction. Nevertheless, the HRV is superior in
predicting the arrhythmogenic events, such as sudden death and ventricular tachycardia.
- Recommendations
Summary and recommendations for the interpretation of the predictive value of decreased HRV
after Acute Myocardial Infarction.
The following should be observed when assessing the prognostic value of HRV in clinical studies
that include survivors of an Acute Myocardial Infarction.
Decreased HRV is a predictor of mortality and arrhythmogenic complications independent from
other risk factors. There is a general consensus that the HRV should be measured a week after
the infarct episode. Although the short term HRV provides prognosis information, the HRV
measured in 24-hour record is a stronger predictor. The short term HRV can be utilized for an
initial assessment of AMI survivors.
For prognosis purposes, there is no better measure than the time domain HRV statistic that
calculates the total HRV (SDNN or the Triangular index). Some other measures, for example, the
ULF spectral density over the 24-hour record, is also useful. A high risk group should be chosen in
conjunction with the following variables: SDNN < 50 or a Triangular index < 15. Even, if the
predictive value of HRV by itself is modest, it is the most important, and the combination with
other risk factors will provide a better diagnosis.
Assessment of Diabetic Neuropathy
Autonomic neuropathy, as a complication of diabetes Mellitus, is characterized by an extensive
and early neuronal degeneration of the small nerve fibers of both the sympathetic and
parasympathetic tract. The clinical manifestations are functional disparity and include postural
hypotension, persistent tachycardia, gastroenteritis and others. Once the clinical manifestations of
the autonomic diabetic neuropathy (AND) take over, the estimated mortality rate after 5 years is
50%. Therefore, the early detection of the autonomic dysfunction is important for risk
stratification and subsequent treatment.
For patients that present NAD real or suspect, there are three HRV measurements from which to
choose:
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Simple measurement methods of RR intervals in bed.
Time domain measurements over long-term recordings which are more sensitive and reproducible
than the short-term recordings.
Frequency domain analysis performed under short-term stationary conditions, which is useful for
the separation of the sympathetic and parasympathetic components.
Long-term measurements in the time domain
The HRV calculated from a 24-hour Holter recording is more sensitive than the HRV calculations
performed on a resting patient test, such as, the Valsalva maneuver, the orthostatic test, deep
breathing test, for the detection of AND. The most frequently used method is the NN50 count and
the SDSD. When the NN50 is used with a confidence interval of less than 95% for total counts in
the range of 500 to 2000, depending on the patient’s age, approximately half of the patients with
diabetes demonstrated abnormally low count values during a 24-hour period. Furthermore, there
is a strong correlation between the percent of patients with abnormal counts, and the extent of
the autonomic neuropathy determined by conventional methods.
In spite of the growing sensibility, these methods of 24 hours, are strongly correlated with other
established measurements of HRV, and have demonstrated reproducible results. Similar to the
survival of AMI, the patients with AND, are also predisposed to sudden death, but the verdict is
still out on whether or not the HRV has a prognostic value for diabetics.
Frequency Domain Measurements
The following abnormalities in the frequency analysis of HRV are associated with AND:
the
1 – Decrease in the spectral power density in all frequency bandwidths.
2 – Lack of LF increase when patient stands up, which is a reflection of the imbalance in
Sympathetic response or decreased sensitivity to baroreflex.
3 – Abnormal reduction of the total power density, without changes in the LF/HF coefficient
4 – A slide of the central LF frequency to the left.
In patients with severe neuropathies resting in supine position the power spectrum presents very
low amplitudes in all spectral components making it difficult to identify the signal from the noise.
In these cases it is advisable to carry out the tests with the patients in standing position.
Future
Investigations connecting changes to the HRV to different cardiopathy and other systemic illness
appear every day. This work is based on information prior to 1996, thus, it is advisable to consult
more recent documentation as well.
To exit this screen, the user can click on any button on the toolbar,
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17 – Hourly Table
Features:
It displays a statistical table, hour by hour, of the complete study.
Screen access:
From the “Significant Events” screen, or clicking on the Hourly Table button.
Each cell shows the value/quantity for the corresponding parameter within a specific hour of the
study. As it can be seen, a cell highlighted in a light color indicates a minimum value, while a dark
color will highlight a maximum value cell.
Open the ECG in a certain one-hour period
The user can instantly visualize the ECG corresponding to any one-hour period in the table; to do
it, simply click on the one-hour period you want to open.
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The following screen will appear:
Current time
Bar Graph
When we click on any of the parameters in the table, the lower part of the screen will display a
bar graph corresponding to the selected classification (e.g.: Beats, VE, SVE, ST C1)
X Axis: Time – Y Axis: Values of the selected parameter
Pacemaker Mode Hourly Table
In case the study was performed to a patient with the GBI-3SM Holter Monitor in Pacemaker
Mode, we will have the possibility to access a special Pacemaker table, by clicking on the PM Table
button:
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The Hourly Table will change to the following format:
To go back to the conventional Hourly Table, click on the Standard Table button.
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18 – RETAINED STRIPS
Features:
It displays all retained ECG strips, and allows their edition.
Screen access:
•
•
From the “Significant Events” screen
By clicking on the Hourly Table button.
If we click on the Hourly Table button and there are no strips retained, the following message
appears:
All the 8-seconds ECG strips that have been retained in the course of the 24-hour analysis can be
visualized and reviewed.
A maximum of 32 eight-second ECG strips in chronological order can be stored. These strips can
be accepted or rejected individually or all together.
The 25mm/sec ECG strips retained may be visualized in screen by clicking twice on the left button
of the mouse.
All the remaining ECG strips may be printed later by selecting the corresponding option in the
printing menu.
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19 – PRINTING REPORTS
Features
Identification of the reports to be printed.
Screen access
•
•
•
From the Hourly Table screen, by clicking on the Next button (if strips have not been
saved)
From the Retained Strips screen, by clicking on the Next button (if strips have been saved)
By clicking on the Print Menu button
Through the Holter Configuration selections, the user chooses which reports are going to be
printed by default (see “Holter Configuration” screen).
The chosen reports are marked in the box next to each option. These options can be temporarily
modified, but the selections will always revert back to the default options when re-entering this
screen.
To make permanent changes on this screen the user should access the second folder of the
“Holter Configuration” screen from the “Main Menu,” and select the Reports option where the
desired selections may be chosen.
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Once the user has included all the desired pages in the final report, the Print icon should then be
selected. To exit this screen without printing, simply select Cancel and the system will go back to
the previous screen.
When selecting the “Conclusions” icon in the upper portion of this screen, the user will be able to
enter conclusions for the study performed. The following screen will appear:
If the “Automatic Conclusion” option in the “Physician Configuration” screen is selected, the
program will automatically write some lines in the conclusion’s field. Otherwise, the screen will be
blank.
Report Print Preview
The View button allows the Holter Report Summary print preview and its edition
After clicking on it, the report preview will appear:
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By means of the scroll bar on the right, the whole preliminary report can be viewed.
The lower part of the report contains the details and the conclusions. Those details are a series of
data that are already included in different parts of the report, and, here, they are summarized.
This details section can be ommited by de-checking this option from the Print Menu. In this case,
all the lower part of the report is left for conclusions printing, which are entered manually by the
operator.
Any of the data in the report preview can be edited by double clicking on it, by means of the
following windows: If it is a numeric value, the user will be able to enter the new one.
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If the parameter has an associated time of occurrence, the window to enter it will be the
following:
By pressing the Erase button, both edition boxes will be cleared.
The patient personal data can be modified by clicking on the Patient Data button, in the Print
Menu.
The following screen will appear:
NOTE: The Institution data CANNOT BE MODIFIED FROM THIS MENU.
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Full-Disclosure Printing
If the “Full Disclosure” box is selected, the user can select to print 1 or 2 hours per page of ECG
signal. Thus, for a 24-hour study 24 or 12 pages can be printed respectively.
The user can also select the number of hours to be printed as shown in the following figure. In
order to do this, the user should select the “Hours” button and then click on each of the hours
he/she wishes to print. As the selection continues, the hours selected will remain “highlighted”
indicating that they have been selected. To de-select an hour press its corresponding icon once
more. Each hour will be printed on a different page.
Selected hours
Note: For good quality Full-Disclosure printing, make sure that the printer graphic properties
have the option “Use Raster graphics” instead of “Use vector graphics” selected.
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20 – RETRIEVE STORED PATIENT INFORMATION
Features
•
•
•
It enables modification of the patient’s information.
It allows to review the patients analyzed and stored in Summary or Complete format.
It displays Retained patients.
Accessing the screen
From the Main Menu, pressing on the “Open” icon located in the toolbar.
20.1 – Store patient files
There are three ways of storing patient files:
In Summary form: The user chooses to save only the files necessary to generate printed reports.
These files allow the user to view, but not modify, the information. The advantage of this storage
system is that the patient files take up to 600 Kbytes, assuming the operator has stored 32 eightsecond strips. The disadvantage of this storage system is that once stored in this way the data
cannot be modified.
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In Complete form: The user chooses to save all the files generated by the Holter analyzer system
together with the 24-hour ECG signal. The advantage of this system is that the user can modify
data, conclusions and study reports. The disadvantage of this format is that each patient study
takes at least 34 Mbytes on the hard disk.
Patient Retained: The 24-hour ECG signal for this patient has been decompressed, and stored for
future analysis.
Patient Information
Patient files are organized by identification number, in ascending order. If a particular patient’s
last name is repeated, the list of last names will show it only once, but in the list of first names
those that share a last name will be shown one by one.
Searching for a particular patient
To find a particular patient, the user can enter the identification number and the system will
search the database to see if it can find a match.
For example: In the following figure the user has only entered the number “12”, and the system
shows the first patient starting with that number and the other in ascending order.
The user can also click on the pop down arrow shown below and select the patient that he/she is
looking for.
Arrow that unfold all the
ID´s found in the Database
Another method consists of searching by the patient’s first and last name.
The lower part of the screen shows all the studies performed on a particular patient, a maximum
of 6 stored in the database.
Current study
Icons that indicate if the current study can be modified or not.
Patient stored in complete format: If when selecting one of the current patient’s studies, the “View
stored studies” and “Reprocess” icons are activated, then this particular patient study was stored
in complete form and thus can be modified and reprocessed.
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Important: If the user decides to reprocess a stored study the analysis, corrections and diagnosis
will be eliminated. It is like processing the ECG study for the first time.
Patient file stored in summary format: If, when selecting a particular study, only the “View stored
study” icon is activated, then the patient study has been saved in summary form, and thus this
study can be viewed, but not modified.
Reducing the filesize of a study stored in complete format (changing to summary format)
To reduce the size of a study, click on the "Reduce Study" button; the study will, then, be stored
in summary format.
20.2 – Study selection
To select a particular study the user should click on the study.
View studies retained
If there are retained studies, these can be viewed by selecting the “View Retained” icon in the
toolbar.
The program will then search through the retained patients and display them on the screen. The
“View stored studies” and “Reprocess” icons will no longer be available. The “Process” icon will be
available as it is the only function that can be performed.
Selected icon
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21 – ERASE PATIENTS
The user can erase a patient’s record and all the reports belonging to that patient by selecting the
“Open” option (Open Patient) in the Main Menu and clicking on the “Erase” button (bottom left
part of the screen).
The program prompts the user to confirm the deletion of the patient’s records. The following
screen will appear.
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22 – STORE PATIENT INFORMATION
Features
Enables to download the patient information without analyzing it.
Accessing the screen
From the toolbar on the Main Menu, select the “Retain” icon.
This function is useful when the user wishes to download and decompress the files from a
“memory card” to the hard disk.
In this case the signal will be decompressed and stored together with the patient information until
the user decides to perform the analysis. This is the same screen accessed when connecting a
memory card or when analyzing a new patient. Once all the data is entered, the user should select
the “Next” icon:
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The system will store the study and then show the following message:
To exit the screen
To exit this screen, select the “Close” icon and the program will return to the Main Menu.
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23 – MORE THAN 24-HOURS RECORDING
In case more than 24 hours have been recorded with the Galix GBI-3SM Holter Recorder, the
WinTer analysis program will detect automatically this recording length and will introduce the
following changes:
A- Trend Graphics: A new Day button will be placed; it will enable to view the days 1, 2 or 3,
corresponding to the first, second and third recorded day (maximum 72 Hours)
B- Full Disclosure: No difference will be noticed at first sight, but the user will be able to scroll the
signal to the end. The day appears on the top-left part of the screen.
C- Morphologies and Significant Events: In both screens, the events shown will correspond to the
total numbers recorded.
D- Hourly Table: In this case, the table also extends for all the recorded time.
E. Print Menu: When more than 24 hours are recorded, it enables to print the trend graphics and
the hourly table corresponding to the different recorded days.
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24 - WARRANTY
GALIX BIOMEDICAL INSTRUMENTATION
Limited Warranty
GALIX Biomedical Instrumentation provides to the original purchaser the following limited
warranty from date of invoice.
All serialized parts
18 months
Accessories
90 days
GALIX Biomedical Instrumentation warrants each instrument to be free from defects in material
and workmanship. Liability under this warranty covers servicing of the instrument when returned
from the customer’s facility prepaid to the factory. GALIX Biomedical Instrumentation will repair
any component(s) or part(s) that is finds to be defective during the period of this limited
warranty. Should a defect become apparent, the original purchaser shall first notify GALIX
Biomedical Instrumentation of the suspected failure. The instrument should be carefully packaged
and shipped prepaid to:
GALIX BIOMEDICAL INSTRUMENTATION
Service Department
2555 Collins Avenue, Suite C-5
Miami Beach, FL 33140, U.S.A.
Tel.: (305) 534-5905 Fax: (305) 534-8222
Your instrument will be repaired in the shortest possible time and returned by the same shipping
method as received by the factory.
This limited warranty is void if the instrument has been damaged by accident, misuse, negligence,
act of God, or if the instrument has been serviced or modified by any person not authorized by
GALIX Biomedical Instrumentation.
Equipment distributed by GALIX Biomedical Instrumentation such as, but not limited to personal
computers and printers will carry the original equipment manufacturer’s warranty and will not be
warranted by GALIX Biomedical Instrumentation.
This limited warranty contains the entire obligation of GALIX Biomedical Instrumentation and no
other warranties expressed, implied or statutory are given. No representative or employee of
GALIX Biomedical Instrumentation is authorized to assume any further liability, or grant any
further warranties except as set herein.
GALIX BIOMEDICAL INSTRUMENTATION
2555 Collins Avenue, Suite C-5
Miami Beach, FL 33140, U.S.A.
Tel.: (305) 534-5905 Fax: (305) 534-8222
E-mail: [email protected]
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