Medicalgorithmics PECGT-III Pocket ECG Monitor User Manual Part 2 092414

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18. NAVIGATOR
18.1. Introduction
The Navigator window of the PC client application consists of a table
listing recording sessions stored on the remote server and a toolbar
with three menus (Fig. 14).
Fig. 14 Navigator view
Every row of the table corresponds to a single recording session.
Information describing the recording sessions are presented in
subsequent columns. The table has columns which provide the
following information:
1)
Location status – informs the user about the location
of the session data. There are five icons representing
five available locations:
session data is located on a remote server
session data is located on a local hard disk
session data is being downloaded
session data is located on the local hard drive
and is not up to date - new data is ready to be
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downloaded from the server.
2)
Last update time indicates the time of the most
recent transmission from the PDA to the remote
server.
3)
Company – company name of the provider.
4)
Message – displays information related to the ECG
data or status of the recording session.
•
important events – events defined as
important are contained in files delivered to the
server from the PDA monitor
•
no-ekg – the ecg signal has not been delivered
to the server for more than 2 hours
•
session ended – session is finished
•
report completed – session is finished and
report has been completed and finalized
5)
Remarks – place where users can write their own
remarks e.g. expected recording duration.
6)
Recorded time – session duration.
7)
Monitor type – type of session.
Columns with icons
( “YES”) and
(“NO”):
8)
Completed – informs whether the session has been
already completed.
9)
Confirmed – informs whether all events in a session
have been confirmed.
10) Clear – informs whether a session is free of
questionable events.
11) First name – patient’s first name,
12) Last name – patient’s last name.
13) Medical supervisor – supervisor’s name.
14) Technician 1 – primary technician’s name.
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15) Technician 2– secondary technician’s name.
16) Ordering physician – ordering physician’s name.
17) Interpreting physician – interpreting physician’s
name.
18) Start time – date and time when the session has
started.
19) Record ID – session ID, comprising of two segments
separated by underscore. The first segment consists
of the session starting time; the second segment
contains the unique ID of the PocketECG transmitter
used for monitoring.
The rows of the table are highlighted with one of four colours. The
colours indicate a role of the currently logged-in user (i.e. supervisor,
technician, etc.). The colours denote the following roles:
Dark green
Light green
White
Yellow
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means that the logged-in user is assigned to the
session as a monitoring specialist (Technician
1/ Technician 2)
means that the logged-in user is assigned to the
session as a Medical supervisor (but not as a
monitoring specialist at the same time),
means that all specialists have been assigned to
the session, and the logged-in user is not
assigned to the session as a monitoring
specialist or supervisor,
means that at least one of the specialists for the
session is missing and the logged-in user is not
assigned to the session as a monitoring
specialist or supervisor.
18.2. Navigator toolbar
Recording sessions presented in the Navigator view may be filtered
and/or sorted. The user can hide/show particular columns of the
navigator table. All the abovementioned functions are available
through three menus located in the application toolbar in the left upper
part of the screen (Fig. 15):
•
•
•
“Hide recording sessions” - allows for selecting sessions that
should not be presented in the Navigator,
“Sorting keys order” - used for selecting the sorting order of the
sessions presented in the Navigator,
“Columns visibility” - allows for selecting the Navigator columns
which are going to be hidden/shown
Fig. 15 Menus: “Hide recording sessions”, “Sorting key orders”,
“Columns visibility”
The “Hide diagnostic sessions” menu contains criteria for hiding the
sessions in the Navigator view. All of the sessions meeting particular
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criterion are not displayed on the list. User may select one or more of
the following criteria:
□
□
□
□
□
□
Confirmed,
Unconfirmed,
Clear,
Unclear,
Completed,
Ongoing,
□ Mine,
□ Other specialists,
□ Unassigned.
"Sorting keys order" menu allows for changing the order of the
recording sessions that are sorted in the Navigator. The sessions are
initially sorted based on the criterion placed on the top in the “sorting
keys order” menu list. Then, all sessions meeting the first criterion are
sorted based on the second criterion, etc. For example: if the first
sorting criterion is “Last name” and the second is “Start time”, then all
sessions for patients with the same last name, e.g. Smith, will be sorted
by their start time. Instead of using "Sorting keys order" menu, the first
sorting criterion may be selected by clicking on the column heading.
The result is equivalent to moving the key to the top of the list in the
“Sorting keys order” menu.
“Columns visibility” menu allows for selecting the information that is
going to be presented in the columns of the Navigator table.
18.3. Adding and editing patient and specialist data
18.3.1. Patients
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The window “Patients” (Fig. 16) allows for adding and editing patients’
personal information. It can be opened by selecting “Add/Edit patients”
option from the Tools Menu. Selecting option “Assign/Edit patients”
from the context menu in the Navigator view, accessible when rightclicking on the recordings list, opens a window which allows for
assigning a patient to the highlighted recording session.
Fig. 16 “Patients” window in “Active patients” mode
Initially, the "Patients” window shows a list of active patients. List of
deleted patients can be accessed through “Removed patients” option.
Options available in the “Patients” window include:
•
Add – shows a form used for adding a new patient to the
database and filling patient personal data, i.e. Last name, First
name, Sex (male/female), Date of birth ID/SSN/PESEL No.,
phone, e-mail and address. Additional (descriptive) information
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•
•
•
regarding the patient may be added/edited in the “Auxiliary
patient info” section.
Edit – activates a form for editing personal data of a selected
patient,
Remove – removes the selected patient from the list of active
patients. The patient's data can be viewed after switching to the
“Removed patients” mode (Fig. 17)
Removed patients – switches to the list of removed patients
("Remove patients" mode).
Fig. 17 “Patients” window in “Removed patients” mode
The “Removed patients” window (Fig. 17) contains the list of removed
patients and two options:
• Undelete – restores the selected patient to the “Active patients”
list,
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Active patients – switches the view to the “Active patients”
mode.
If a patient is already assigned to a session, right-clicking on the
session and selecting “Edit / View patient information” opens a
window where patient information can be viewed or edited (Fig. 18).
The same form is opened when selecting the “Edit” in the “Active
patients” view.
•
Fig. 18“Add/Edit Patient data” window contains patient’s personal
information.
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18.3.2. Specialists
The “Specialists” window is used for adding and editing specialists’
personal data. It can be opened by selecting “Add/Edit specialists”
option from the Tools Menu
or by selecting “Assign/Edit
specialists” from the context menu. The “Specialists” window has been
designed in a similar way to the “Patients” window (see Figs. 18 and
19).
Fig. 19 “Specialist” window for adding/editing specialists’ data
A single specialist may be assigned to multiple roles. The available
roles in the system are:
•
Medical Supervisor,
•
Technician 1,
•
Technician 2,
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•
Ordering physician,
•
Interpreting physician,
•
Administrator.
The “Detailed Settings” button allows for setting up specific rights of
the edited specialist. Specialists may have the following rights:
•
Ability to assign sessions,
•
Full administration access,
•
Specialist’s data modification,
•
Patient’s data modification.
•
Sign groups reports.
•
Enroll for other group members
•
Technician’s interpretation modification
•
Physician’s interpretation modification
The “User settings” tab allows for selecting how notifications about
new reports are going to be delivered to the specialist. In addition, the
user may decide whether the PC client should automatically download
the ECG data for the assigned sessions.
18.3.3. Relations between specialists, patients and PocketECG
transmitters
The PC client application provides information about relations
between specialists, patients and PocketECG transmitter. Every time a
specialist and a PocketECG transmitter are assigned to the same
recording session a relation between them is created. These relations
may be edited using “Add/Edit Specialists - transmitter relations”
window (Fig. 20). The list of all available specialists is located on the
left side of the window. After selecting a specialist, the related patients,
transmitters and other specialists appear on the right. These relations
may be added or removed using “Add” and “Remove” buttons,
respectively.
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The list presented on the left side of the window, depending on the
selected tab, contains specialist names, patient names or transmitter
IDs.
Fig. 20 “Add/Edit specialist - transmitter relation” window
18.4. Assigning patients / specialists to recording session
Every time a new recording session is detected by the software, the PC
client pops up a window for assigning patients and specialists (Fig. 21).
The patients or specialists can be assigned to the new session through
“Select” buttons (see Fig. 21).
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Fig. 21 Window for assigning patients and specialists
Patients and physicians may also be assigned to recording sessions
using Navigator of the PC client application, by double-clicking on the
table cells with patient’s or specialist’s name. Alternatively, it is
possible to assign patients and specialists by right-clicking on the list
and selecting the appropriate option from the context menu, i.e.
“Assign / Edit patient” or “Assign / Edit specialist”.
18.5. Downloading and removing recording session data
Session data is downloaded automatically under the following
conditions:
•
the logged-in user is assigned to the session as a supervisor or
technician
•
new data is available on the server
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•
the session has not yet been completed.
It is possible at any time to download the selected recording manually
by right-clicking on the session and selecting the “Download” option
from the context menu. The icon
appears in the "Location status"
column of the Navigator when the session data is successfully
downloaded to the local hard drive.
The recording session data may be removed either from the local hard
disk drive (HDD) or marked as removed – i.e. moved to the Garbage
folder on the server and removed from all users’ HDDs. In order to
remove the session data, right-click on the chosen session and select
one of the following options:
Remove → from local HDD – removes recording session data
from the local disk (available only for already downloaded
sessions),
• Remove → from server and all users’ HDDs –marks the
session as removed on the server and removes it from local
disks of all users that have downloaded the session.
Normally, in order to finish a recording session, an appropriate option
should be selected through the transmitter. It is possible, however, to
set the session status to “finished” through the PC client software – by
right-clicking on the selected session and selecting the “Finish” option
from the context menu.
•
18.6. Remote communication with the transmitter
After right-clicking on a session shown on the Navigator list, two main
options related to the transmitters are available: “Transmitter Settings”
and “View transmitter log”. After selecting the “Transmitter Settings”
option, all arrhythmia settings of the PocketECG transmitter are
displayed and are available for modification.
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In order to display a window containing information related to the
state of patient's equipment (Fig. 22), the "View Transmitter log"
option should be selected.
Fig. 22 “Transmitter Log Viewer” window displaying session logs.
The transmitter log provides the following information:
•
Log creation time,
•
device battery level,
•
SD memory left,
•
Storage memory for programs,
•
Available RAM,
•
Spotted communication errors,
The logs are generated by the transmitter's software every hour and
transmitted to the PocketECG PC Client. In order to navigate through
all generated logs the arrows displayed on the top of the window
should be used. The single arrows (< and >) allow for switching
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between subsequent logs. The double arrows (<< and >>) jump to logs
generated every 24 h.
18.7. Communication with the SD card through USB
The PC client application communicates with a SD card connected with
the PC using the USB card reader. All recording sessions stored in the
SD card are added to the list of displayed sessions presented by the
Navigator which is indicated by the
icon. From the context menu,
the user may select the following options for managing the data on the
SD card:
•
Download → from SD card through USB - downloads session data
from the SD card to the local hard drive,
•
Remove → from SD card through USB - removes a session from
the SD card,
•
Archive → from SD card through USB - compresses session files
and moves them to C:\LocalDataRoot \Archive folder.
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19. EVENT VIEW
19.1. Introduction
In order to get access to the ECG data presented in the Event View, Full
Disclosure, Trends or Reports, the ECG data corresponding to the
selected session must be earlier downloaded to the local hard drive.
The results of the ECG signals analysis performed by the PocketECG
transmitter are presented in the Event View of the PC client application
(Fig. 23).
Fig. 23 Event view
All detected events are presented in a table (every row corresponds to
a single event). After selecting a particular event from the table, the
relevant ECG strip is displayed in the upper sub-window. The table
presented in the Event View has columns providing the following
information which describe all events:
•
Time – day number and the exact time of event occurrence,
Page 81 of 118
•
Morphology – index of recognized morphology class –
recognition is performed after clicking on the head of the column for
sorting
•
Rate – heart rate during the event,
•
Beats - number of successive heartbeats in a given event,
•
Noise – noise level in microvolts,
•
Description – event’s description,
•
Status – event status. There are four different options:
o Confirmed,
o Unconfirmed,
o Deleted,
o Unclear.
•
Strip - this field is selected when an ECG strip corresponding to
the event will be shown in the report.
Every line of the table presenting detected events is highlighted with
one of the six colors corresponding to certain types of events:
Pink
Heart rate
Red
Ventricular
Green
Supraventricular
Yellow
ST changes
Grey
Other
White
Marked beat
A detailed description of the ECG annotations displayed in the upper
part of the screen is given in section 20. Full disclosure.
19.2. Filtering and sorting the events list
The list of events may be filtered by type - using the tree-organized
filter located in the left part of the screen. Additionally, the list may be
filtered by events status, day or morphology.
The tree-organized list contains the following elements:
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•
•
•
•
•
•
•
•
Critical & important events
Patient triggered
Heart rate
o Fastest minutely HR
o Average minutely HR
o Slowest minutely HR
o Asystole
o Pause
o Bradycardia
o Missed beat
Ventricular
o Single Premature Beat
o Couplet
o Triplet
o VT
o Bigeminy
o Trigeminy
o IVR
o AIVR
o R on T
Supraventricular
o Single Premature Beat
o Couplet
o Triplet
o SVR
o AF
o Bigeminy
o Trigeminy
ST Changes
Operator selected
Other
o Electrode Contact Loss
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o Signal synchronization loss
o Unrecognized
o Marked beat.
“Filter by status” allows for limiting the list of events to those with
selected status and similarly "Filter by day" limits the list to events that
took place during a selected day, or during all days. “Filter by
morphology” limits the list to events containing beats with selected
morphology index – the filter activates after performing morphology
grouping.
19.3. Events reviewing
In order to change an event description, right-click on the event and
select “Edit description” option from the context menu. All changes
introduced to the description of events may be undone using “Reset to
default” option. All beat annotations generated by the PDA can be
modified using the following keyboard shortcuts:
o v – to ventricular,
o s – to supraventricular,
o a – to atrial fibrillation,
o n - to normal,
o x – to artifact.
The “Status” of events may be modified in two ways:
•
by clicking on the “Status” cell on the event list – the status changes
in the following order: Unconfirmed → Confirmed → Deleted →
Unclear → Unconfirmed,
•
by selecting a given event on the list and using one of the keyboard
keys:
c – changes status to “Confirmed”,
d – changes status to “Deleted”,
u - changes status to “Unclear”,
shift+u – changes status to “Unconfirmed”.
o shift+g – selects morphology group
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If none of the events has "Unconfirmed" status, the recording session
status is presented as "Confirmed" using the green
icon on the
Navigator list. If none of the events has "Unclear" status, the recording
session status is presented as "Clear" using the green
icon on the
Navigator list.
The ECG strip containing the detected event may be added to the
following reports generated by the PC client application (Fig. 24):
•
•
•
Daily only,
Cumulative and daily,
Urgent, cumulative and daily.
Fig. 24 Selection of strips for report
19.4. Navigation through the ECG recording
The ECG waveform displayed in the upper part of the screen
corresponds to the event marked on the list. To navigate through the
ECG use the transport buttons (<, <<, >>, >) on the toolbar or the arrow
keys of the keyboard:
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•
pressing the double arrow buttons on the toolbar moves the ECG
record backward or forward by the length of the displayed strip (8
seconds),
•
pressing the single arrow buttons moves the record backward or
forward by 200 milliseconds,
•
horizontal arrows on the PC keyboard move the record backward
or forward by 200 milliseconds,
19.5. ECG display settings and transmitter settings
Tools for changing the ECG waveform vertical scale and other
parameters related to ECG display are described in section 20.3.
Transmitter settings are described in sections 18.6.
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20. FULL DISCLOSURE
20.1. Introduction
The PocketECG PC Client provides access to full disclosure ECG
recording. The ECG waveforms may be viewed using the Full
Disclosure view of the PC client application, as shown in Fig. 25.
Fig. 25 Full Disclosure view
The timeline bar is displayed in the upper part of the screen. The user
may click on the timeline bar in order to navigate directly to any time
in the recording. The ECG waveform is displayed in normal size - as 8 s
strip in the upper part of the screen and as a miniaturized signal in the
bottom part of the screen (30 s of the signal in each row). User may
click on the miniaturized ECG and the corresponding full size strip will
be displayed in the upper part of the screen. The displayed strip is
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indicated by yellow frame highlighting the corresponding miniaturized
ECG fragment. The enlarged fragment of the Full Disclosure view
containing the ECG strip is presented in Fig. 26. The PocketECG
automatically detects and classifies QRS complexes. The annotations
for all detected complexes are displayed above the ECG beats (2). The
instantaneous heart rate is displayed between the ECG beat labels (3).
Fig. 26 ECG waveforms presented in the upper part of the screen
The PocketECG transmitter allows the patient to report symptoms
manually. The ECG strip reported (marked) by the patient is presented
in the Full Disclosure view with a long grey stripe marked with
"triggered by patient" label located under the ECG waveform (Fig. 27)
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Fig. 27 ECG waveforms marked as "triggered by patient"
20.2. Navigation through the ECG recording
The user can jump to the next selected ECG region or to heart beats
meeting pre-defined criteria (Fig. 28). After clicking on the drop-down
menu located in the left upper corner of the window it is possible to
define the navigation criteria for the arrow buttons (Fig. 28).
Fig. 28 Navigation menu
If the “Selected region” option is selected, then the arrow buttons will
skip to the next / previous selection onset / offset. The “Strip position”
allows to navigate within selected event, from beats just before event,
to middle part of event, and to beats just after event. Selecting "Beat
type" option will show a window which will allow the user to specify
beat-type and other beat related criteria for navigation (Fig. 29).
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Fig. 29 "Skip to the next beat meeting the criteria" window
The transport toolbar has three options:
1. skip by one hour,
2. skip by 30 seconds,
3. move the record by 200 ms periods.
Pressing "Jump to" button opens a drop-down list with five options:
•
•
•
•
•
Time – jumps to specified time,
Max minutely HR – jumps to the max HR strip,
Higher minutely HR – jumps to the next higher HR strip,
Lower minutely HR – jumps to the next lower HR strip,
Min minutely HR – jumps to the min HR strip.
20.3. ECG display settings and re-annotations
The toolbar in the Full Disclosure view contains "EKG view mode"
menu. This menu allows for changing settings which influence the way
the ECG waveform is displayed. The following options are available:
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•
•
•
•
•
•
•
Automatically scroll when new data arrives - when new data is
received, strip corresponding to the last 8 seconds of the signal is
presented automatically in the upper part of the screen and the
miniaturized ECG is updated.
Brighten/darken annotation boxes - used for brightening or
darkening colors of the annotation boxes presented in the bottom
part of the window.
EKG baseline up/down - moves the ECG signal up or down,
Increase/decrease the number of EKG rows - modifies the
number of miniaturized ECG rows displayed in the bottom of the
screen (and automatically changes the amplitude range of each
row),
Vertical scale - used for modifying the amplitude scale of the
displayed full size ECG strip (upper part of the screen),
R-R intervals - changes the R-R interval display format from beats
per minute (BPM) to milliseconds (ms).
Waveform - allows for filtering out/retaining the interferences and
disturbances in the presented waveforms.
There are also three other tabs located in the toolbar of the Full
Disclosure view:
•
•
•
Add strip – creates Operator selected event and allows for attaching
the strip to the report,
Filters - allows for switching between single and all-day displaying
modes
Annotations - there are two options under this menu item:
o Re-annotate/modify selection - opens a window
presented in Fig. 30 (described below),
o Modify status of events within selection
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Fig. 30 "Re-annotate/Modify selection" window
The window Re-annotate/Modify selection (Fig. 30) allows for
modification of beat labels generated by the PocketECG transmitter
software. The modification is applied to the annotations listed and
checked in the left section of the screen. The filters located in the right
section of the window allow for limiting the pre-selected beats based
on HR criteria. The center section of the window allows for selecting
the target beat annotations (to which the input beat annotations will be
modified).
It is possible to measure heart rate/R-R interval and signal peak-topeak amplitude manually using the ECG caliper (Fig. 31). In order to
activate this tool, hold the mouse button and then move the cursor to
the right adjusting the size of the displayed caliper. The measured
parameters are displayed under the tool.
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Fig. 31 Ruler tool
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21. TRENDS
Interactive trends illustrating variations of the averaged HR, AF
burden, bradycardia burden, ventricular or supraventricular beats and
runs count, as well as ST levels are available in the Trends view of the
PC client software. The trends may be displayed in two modes:
•
Continuous trends - the upper part of the screen shows the full
size ECG strip and the bottom part of the screen shows the
trends (Fig. 32).
•
Daily trends - each daily trend for each parameter is presented
in a separate tab. Each day is presented in a separate row (Fig.
33)
The control buttons and options located in the toolbar are similar to
those already described in section 22. However, the buttons with
double arrows (<< and >>) rewind the recordings by 24 hours. The
buttons with single arrows rewind the waveforms by 1 hour. There are
also additional buttons located in the upper toolbar, which are not
available in the Full Disclosure view (Hide/show ECG strip and Zoom
in/out). The daily trend of a particular parameter may be attached to
the final report. If this is desired, mark the checkbox located in the
right corner of every window containing trend diagrams.
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Fig. 32 Continuous trends
Page 95 of 118
Fig. 33 Daily trends
21.1. Acceleration trend
The PocketECG transmitter sends to the remote server both: ECG and
acceleration data. The acceleration data can be reviewed in the Trend
view together with other trends e.g. heart rate. The sample ECG strip
together with heart rate trend and acceleration trend is presented in
Fig. 34.
Page 96 of 118
Fig. 34 Heart rate and acceleration trends
Page 97 of 118
22. IMPRESSIONS AND FINDINGS
Impressions and Findings is a notepad for user's remarks. The user is
able to add comments related either to a single day of the recording or
make general notes regarding the entire recording session. The arrows
in the upper part of the screen allow for navigation through the notes.
If "Day:x" is displayed between the navigation arrows, the added
comment relates to day number x. The “Day:All” notice displayed
between navigation arrows indicates that the comments refer to the
entire recording session. The notes are attached to the reports
generated by the PC client application – the main note is attached to
the summary report, while the daily notes are attached to the
corresponding daily reports.
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23. REPORTS
23.1. Introduction
The Reports view consists of a table containing a list of all reports
generated during the recording session (Fig. 35). There are five types
of reports presented in the Reports view of application:
•
•
•
•
•
cumulative reports,
end of study reports,
daily reports,
urgent reports,
event reports.
Fig. 35 Reports view
The table containing generated reports has columns with the following
headers:
• Action – contains “Open” button which allows to open the report,
• From – defines the start time of the period covered by the report,
• To – defines the end time of the period covered by the report,
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•
•
•
•
•
•
Day– defines the day covered by the report; “All” stands for the
cumulative/end of study report,
Description – description of the report,
Trends – the diagrams selected using the Trends view of the
application are attached to the report if this checkbox is selected,
Strips – the ECG strips chosen using the Event View of the
application are attached to the report if this checkbox is selected,
Full disclosure –the miniaturized ECG waveforms are attached to
the report if this checkbox is selected,
Last publication – date of last publication of the report with the
author's name
23.2. Reports viewing
In order to display a report, select it from the list and then choose the
“View report” command (toolbar) or press the button “Open”. Doubleclicking on the particular row in the table also opens the corresponding
report. The report contains the ECG strips previously selected to be
attached using the Event View of the application. Furthermore, the
notes added using the Impressions and Findings view are also included
in the report.
23.3. Reports editing
Reports may be modified manually after clicking the "Edit report
statistics" button located in the toolbar of the application. The window
for editing reports is presented in Fig. 36.
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Fig. 36 Report editor
All introduced modifications must be confirmed by clicking the
"Accept" button. In order to reject the changes and restore the original
report select "Cancel" or "Cancel Edit".
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24. GARBAGE
The list of all recording sessions removed from the remote server is
presented in the Garbage view of the PC client application. The list may
be sorted and filtered using the pop-out menus located in the toolbar.
The following menu options: “Hide recording sessions”, “Sorting key
order” and “Columns visibility” are identical to the options available in
the Navigator and described in detail in section 24. The recording
sessions placed in the Garbage folder may be moved back to the main
folder and further accessed using the Navigator. In order to restore a
recording session press the right button on the PC mouse and then
select the "Undelete" command. If the restored session has no
specialists assigned, the window for assigning patients and specialist is
displayed (see section 24.4).
25. ARCHIVE
It is a list of all recording sessions which were located on the remote
server and then archived in the Archive view of the PC client
application. The list may be sorted and filtered using menu options
located in the toolbar. The following menu options: “Hide recording
sessions”, “Sorting key order” and “Columns visibility” are identical to
the options available in the Navigator and described in detail in section
24. The recording sessions placed in the Archive folder may be moved
back to the main folder and further accessed using the Navigator. In
order to restore a recording session press the right button on the PC
mouse and then select the "De-archive" command. If the de-archived
session has no specialists assigned, the window for assigning patients
and specialist is displayed (see section 24.4).
26. TOOLS MENU
The main menu of the application called the “Tools Menu” is located in
the upper left corner of the main window and is represented by the
icon. The pop-out menu has the following options/commands:
Page 102 of 118
Change user
Logs out the current user and displays a
window for entering a new login and
password.
Add / Edit specialists
Activates a window for adding and
editing specialists’ personal data, as
described in section 18.3.2.
Add / Edit patients
Activates a window for adding and
editing patients’ personal data, as
described in section 18.3.1.
Clean local database
Removes both: ECG data and recording
session files already downloaded to the
hard drive and initiates a restart of the
application.
Import session from
hard disc
Activates a window for choosing the
session data that are going to be imported
from the local hard drive.
Export billing data
Saves the ECG data of selected session to
a csv file.
Open session directory
Opens the folder which stores all the
session files.
Settings
Opens a window which contains the
global setting related to the remote
server and the user interface.
Clear all re-annotations
Clears all re-annotations introduced by
the user during reviewing.
Archive all from SD card
Moves data from recording sessions
stored on the SD card (connected through
the USB card reader with PC/tablet) to
the Archive folder of the PC client.
Add/Edit
Specialist/transmitters
relations
Opens a window for editing
specialists/user/transmitter relations, as
described in section 18.3.3.
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Export action log
Exports a list of actions performed by the
user for the highlighted recording session
along with time stamps.
Load data from backup
Export
ECG
Signal data
Exports the signal data to a text file.
Annotations
Exports the ECG annotations to a text file.
data
Page 104 of 118
C. ADDITIONAL INFORMATION
27. MEDICAL INCIDENT
Caution. Should a medical incident take place, as
defined by the medical devices act of February 2, 2011,
notify the manufacturer immediately.
MEDICALGORITHMICS SA
Jerozolimskie 81
02-001 Warsaw, Poland
tel./fax.: + 48 22 825 1249
e-mail: technical@medicalgorithmics.com
Page 105 of 118
28. TROUBLESHOOTING
Problem
Probable cause(s) and solution
It is impossible to turn
on the PocketECG
transmitter.
The battery is discharged. Replace the
battery with a fully charged one.
The ECG signals
displayed by the
PocketECG transmitter
are of low amplitude
and disturbed.
Poor skin preparation or the electrodes
past their use-by date.
Remove hair and grease from where the
electrode is to be attached and use singleuse electrodes designed for long-term ECG
monitoring.
It is impossible to start
new recording session.
The recording session cannot be initiated
if:
- the SD card is not installed
- the device is powered from backup
battery
If you cannot initiate recording session
after checking abovementioned issues,
contact PocketECG service provider.
Recording session
stopped
unintentionally.
The memory card is full. Format the
memory card.
The monitoring data is
not stored properly –
the application notifies
about errors.
The writing and/or reading speed of the
memory card is not sufficient. Use memory
cards of at least 100 kbps reading and
writing speed.
The device screen
cannot be unlocked.
Press the service provider logo for 3
seconds and then type the unlocking code:
1 2 3 6.
The recording session
Check the session status in the 'supervisor
Page 106 of 118
has been successfully
started on the
PocketECG transmitter,
but it is not listed in the
PocketECG client
application.
view' → About → Session info- the '[OK]'
text string indicates that the wireless
connection between PocketECG
transmitter and remote server has been
successfully established. If instead of '[OK]'
an error code is displayed in the brackets,
the transmitter cannot connect to the
remote server. Ensure that the Internet
connection is properly configured on the
phone and that it is within the mobile
network range. If the '[OK]' status is
displayed and the newly started recording
session still cannot be found in the
PocketECG Client application, the PC
operating PocketECG Client does not have
an active Internet connection. Consult your
PocketECG distributor or service provider
for support.
The recording session
has been finished, but
the mobile phone
network is not working
(ECG data cannot be
transmitted) or internet
is inaccessible due to its
infrastructure failure.
Finish the recording session and remove
SD card from the PocketECG transmitter.
Use micro SD card reader equipped with
USB interface and connect it to the PC
operating the PocketECG Client application
and download the ECG data from the SD
card to the local hard drive (refer to
subsection 18.7).
The PocketECG Client
application cannot
communicate with the
remote server - the ECG
data cannot be
downloaded.
Refer to subsection 17.1
Page 107 of 118
29. TECHNICAL PARAMETERS
Model
Type
Wireless
communication
PocketECG III
PECGT-III
Quad band GSM EDGE, UMTS 850 / 1900
/ 2100MHz. The wireless data
transmission technologies: GPRS, EDGE,
HSDPA, HSUPA.
Group/class according
I/B
to CISPR 11
a Lithium-ion battery 3.7V type: PECGBPowered by
III (1700 mAh)
Power consumption
< 2.5A (in transmission mode)
Working time
at least 24 hours
Input impedance
> 10 Mohm
CMRR
> 60 dB
Sampling rate
300 Sa/s
Registered signal
0.05 - 60 Hz
band
Input dynamic range
+/- 5 mV
Acceptable constant
+/- 300 mV
component
1) Temperature: 0 ºC ÷ +43ºC (32 to
1090F );
2) Relative humidity range of 15 % to
Operating conditions
93 %, non-condensing;
3) Atmospheric pressure: 700 hPa to
1060 hPa.
1) Temperature: -20 ºC ÷ +60ºC (-4 to
Transport conditions, 140ºF)
Storage conditions,
2) Relative humidity up to 93 %, nonStorage between uses condensing.
conditions
2) Atmospheric pressure: 700 hPa to
1060 hPa
Page 108 of 118
Dimensions
Weight (with battery)
167x 79 x 14,5 mm (without cable)
161 g
Page 109 of 118
30. SERVICE
Service is provided only by Medicalgorithmics S.A. In case of any
product malfunction a device shall be returned directly to
manufacturer to the following address:
MEDICALGORITHMICS S.A.
Jerozolimskie 81
02-001 Warsaw, Poland
tel./fax.: + 48 22 825 1249
e-mail: technical@medicalgorithmics.com
31. DECLARATION OF CONFORMITY
If you would like to receive the declaration of conformity, contact with
the manufacturer on the following address:
MEDICALGORITHMICS S.A.
Jerozolimskie 81
02-001 Warsaw, Poland
e-mail: technical@medicalgorithmics.com
32. LIMITED WARRANTY STATEMENT
This limited warranty shall apply to a product (“Product”) supplied by
MEDICALGORITHMICS. MEDICALGORITHMICS warrants that at the time of its
original purchase the product is free of defects in materials and
workmanship (“Limited Warranty”). THIS LIMITED WARRANTY DOES NOT
AFFECT YOUR STATUTORY RIGHTS.
This Limited warranty is subject to the following terms and conditions:
1. This Limited Warranty is given only to the original purchaser of the
Product (“Customer”). This Limited Warranty may, however, be
transferred to any individual to whom the Product is sold, where
MEDICALGORITHMICS has consented in writing to the transfer (and
Page 110 of 118
MEDICALGORITHMICS will not unreasonably refuse consent). It shall
neither exclude nor limit
a) any statutory rights of the Customer or
b) any of the Customer’s rights against the seller/dealer of the Product.
2. This Limited Warranty shall last for twelve (12) months from the
date of original purchase for the ECG transmitter, and twelve (12)
months for accessories (whether included in the ECG transmitter sales
package or sold separately) other than the media, on which software is
provided, CD-ROM, memory card (“Warranty Period”).
Customer shall present the PROOF OF PURCHASE and the SERIAL NUMBER OF
POCKETECG TRANSMITTER upon claiming this Limited Warranty. This
Limited Warranty is only valid and enforceable in the countries where
the Product is sold. However, if you have purchased the Product in a
member state of the European Union, Iceland, Norway, Switzerland or
Turkey and MEDICALGORITHMICS originally intended the Product for sale
in one of these countries, this Limited Warranty is valid and
enforceable in all of the above listed countries. Moreover, if Product is
purchased in places other than those stated above, MEDICALGORITHMICS
will attempt to repair such Product but cannot guarantee the outcome.
Warranty service availability and response times may vary from
country to country and may also be subject to a registration
requirement in the country of purchase.
3. Throughout the Warranty Period MEDICALGORITHMICS or its
authorized agent will, at their discretion repair or replace a defective
Product free of charge, subject to Clause 6. Repair or replacement may
involve the use of functionally equivalent reconditioned unit.
MEDICALGORITHMICS will return the repaired Product or will replace it
with another functionally equivalent Product in good working
condition. All replaced faulty parts or components will become the
property of MEDICALGORITHMICS.
Page 111 of 118
4. This Limited Warranty applies only to the hardware components of
the Product as originally supplied and does not apply to any software
or other equipment.
5. If MEDICALGORITHMICS repairs or replaces the product, the repaired or
replaced Product shall continue to be warranted for the remaining time
of the original Warranty Period or for three (3) months from the date
of repair or replacement, whichever is longer.
6. THIS LIMITED WARRANTY SHALL NOT APPLY IF:
a) the Product serial number, the accessory date has been removed,
erased, defected, altered or is illegible; or
b) deterioration of the Product is due to normal wear and tear; or
c) the Product was used other than as described in the user manual,
subjected to rough handling, exposed to moisture, dampness or
extreme thermal or environmental conditions or a rapid change in such
conditions, corrosion, oxidation, subjected to unauthorized
modifications or connections, unauthorized opening or repair, repair
by use of unauthorized spare parts, accidents, forces of nature, or other
actions beyond the reasonable control of MEDICALGORITHMICS (including
but not limited to deficiencies in consumable parts) unless the defect
was caused directly by defects in materials or workmanship. This
Limited Warranty does not cover physical damage to the surface of the
Product; or
d) the defects result from the fact that the battery has been shortcircuited or from the fact that the seals of the battery enclosure or the
cells are broken or show evidence of tampering or from the fact that
the battery has been used in equipment other than those for which it
has been specified; or
e) the Product software needs to be upgraded due to changes in
cellular network parameters; or
Page 112 of 118
f) the defect was caused by the fact that the Product was used with or
connected to an accessory not approved or provided by
MEDICALGORITHMICS or used not as intended and where it can be shown
by MEDICALGORITHMICS that such defect is not the fault of the Product
itself.
7. Your Product may contain country specify elements, if the Product
has been re-exported from its original destination country to another
country, the Product may contain country specific elements that are
not considered to be a defect under this Limited Warranty.
CUSTOMER MUST NOTIFY MEDICALGORITHMICS OR A MEDICALGORITHMICS
AUTHORIZED SERVICE AGENT OF A CLAIM UNDER THIS LIMITED WARRANTY AND OF
THE ALLEGED DEFECT WITHIN A REASONABLE TIME AFTER NOTICING THE DEFECT
AND IN ANY EVENT NO LATER THAN BEFORE THE EXPIRY OF THE WARRANTY PERIOD.
8. In the event of Product failure, the Customer should take the
following actions:
a) refer to the user manual in order to identify and possibly correct the
problem,
b) if the problem cannot be resolved by referring to the user manual
the Customer should contact the dealer where the Product was
purchased,
c) before the Customer contacts the MEDICALGORITHMICS service agent,
please ensure the following information is at hand:
- The model and serial number of the Product,
- The customer’s full address and contact information.
- A copy of the Customer’s original invoice, receipt or bill of sale for the
purchase of the Product.
MEDICALGORITHMICS will provide the Customer with instructions
regarding how and when the defective Product should be returned.
MEDICALGORITHMICS will pay both for the return of the defective product
Page 113 of 118
to MEDICALGORITHMICS and for sending the repaired Product back to the
Customer if the Defective Product is within the Warranty Period.
9. THIS LIMITED WARRANTY STATES THE ENTIRE WARRANTY GIVEN BY
MEDICALGORITHMICS TO THE CUSTOMER.
IN NO EVENT SHALL MEDICALGORITHMICS BE LIABLE UNDER THIS LIMITED
WARRANTY FOR LOSS OF PROFIT, LOSS OF ANTICIPATED SAVINGS, LOSS OF DATA OR
INDIRECT LOSS OF USE OF THE PRODUCT OR ANY ASSOCIATED EQUIPMENT,
INCIDENTAL OR CONSEQUENTIAL LOSSES OR DAMAGES OF ANY NATURE
WHATSOEVER TO THE FULLEST EXTENT THAT THOSE LOSSES OR DAMAGES CAN BE
DISCLAIMED BY LAW.
In any case MEDICALGORITHMICS and its suppliers’ entire liability under
any provision of this Limited Warranty shall be limited to the amount
actually paid by the Customer for the hardware. MEDICALGORITHMICS
does not exclude or limit liability for personal injury or death resulting
from its own negligence, for defects in the Product arising out of its or
its manufacturers’ negligence, under Part I of the Consumer Protection
Act 1987 or for fraudulent misrepresentation.
The laws of some countries prohibit Medicalgorithmics from excluding
or limiting its liability. In such cases, the exclusions and limitations of
liability in this Limited Warranty will not apply.
This Limited Warranty gives the Customer specific legal rights; the
Customer may also have other rights, which may vary from country to
country.
This limited warranty does not affect the Customers’ statutory rights in
law specific to the country of purchase, such rights remain protected.
33. SOFTWARE LICENSE AGREEMENT
Terms and definitions:
•
AGREEMENT – this License Agreement.
Page 114 of 118
•
PRODUCER – Medicalgorithmics S.A.
•
LICENSEE – party that is entering into this Agreement with Producer
•
PRODUCT – software, data and related material contained in the
PocketECG package
PRODUCER IS WILLING TO LICENSE PRODUCT TO LICENSEE ONLY
ON THE CONDITION THAT LICENSEE ACCEPTS ALL THE TERMS
AND CODITIONS STATED IN THIS AGREEMENT. BY INSTALLING OR
USING THE PRODUCT THE LICENSEE INDICATES ACCEPTANCE OF
THIS AGREEMENT.
RESERVATION OF O WNERS HIP AND GRANT OF LIC ENSE
All rights not specifically granted in this Agreement are reserved to
Producer. Product is owned by Producer and its third party licensor(s)
and is protected by copyrights laws. Producer and its third party
licensor(s) retain exclusive rights, title and ownership of the copy of
the Product. Hereby Producer grants to Licensee a personal,
nonexclusive nontransferable license to use Product on the terms and
conditions of this Agreement. Licensee agrees to use every reasonable
effort to protect Product from unauthorized use, reproduction,
distribution or publication.
PERMITTED USES
a) Licensee may install and use Product on only one computer system
and only if that computer is for Licensee’s own internal use and
constitutes Licensee’s own property.
b) Licensee may make two backup copies of the Product.
USES NOT PERMITTED
Page 115 of 118
a) Licensee shall not reverse, engineer, decompile, or disassemble the
software contained in Product.
b) Licensee shall not remove or obscure Producer copyright or
trademark notices.
TERMINATION
Licensee may terminate this Agreement at any time by returning
Product in its entirety to Producer. Producer may terminate this
Agreement in case of the Licensee’s material breach of this Agreement.
If Agreement is terminated after the warranty period, Producer will not
reimburse the purchase price.
LIMITED WARRANTY
Producer warrants that the media upon which Product is provided will
be free from defects in material and workmanship under normal use
and service for a period of ninety (90) days from the date of receipt. If a
defect is found that was not caused by improper use, Producer at its
own discretion will exchange Product for a defect-free or reimburse
the price paid by Licensee. Producer made every effort to provide
flawless operation of Product’s functions. Nonetheless Licensee
understands that Product may contain some errors, defects, omissions
or nonconformities. Therefore Producer and the respective third party
licensor(s) discourage Licensee from relying exclusively on data
generated by the Product.
EXCLUSIVE REMEDY AND LIMIATATION OF LIABILITY
Producer’s entire liability and Licensee’s exclusive remedy during the
warranty period shall be the return of the license fee paid for the
Product or exchange of Product as described in the Limited Warranty
above. Producer shall not be liable for indirect, incidental or
consequential damages related to Licensee’s use of Product, even if
Producer is advised of the possibility of such damage.
Page 116 of 118
WAIVERS
No failure or delay by Producer in enforcing any right or remedy under
this Agreement shall be construed as a waiver of any future or other
exercise of such right or remedy by Producer.
ORDER OF PRECEDENCE
Terms expressed in this Agreement have precedence over those
expressed in purchase order or other purchase arrangements unless
agreed otherwise.
GOVERNING LAW
All rights and duties under this Agreement shall be governed by the
commercial law of the country where the license is purchased with
exception of copyright, patent, and trademark issues. Those shall be
governed by the laws of Poland and the applicable international
treaties and conventions.
ENTIRE AGREEMENT
The parties agree that this Agreement constitutes the sole and entire
agreement of the parties as to the matter set forth herein and
supersedes any previous agreements, understandings and
arrangements between Producer and Licensee and is effective, valid
and binding upon parties.
Page 117 of 118
0197
Page 118 of 118

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