LX Event Holter Monitor and Event Recorders

LX Event
User’s Manual

for use with
NorthEast Monitoring’s
Event Recorders

Version 3.1.4

Part number: NEMM016_Rev_U
Last updated: February 13, 2023
Copyright 2007 – 2023
All rights reserved

LX Event User’s Manual

NorthEast Monitoring is an FDA Registered Facility, number 1224919,  that follows all FDA CGMP Manufacturing Practices.

LX Event has been developed by NorthEast Monitoring, Inc.

LX Event has FDA 510(k) Market Approval Number K070014.

This product, like all Holter monitoring products,

should be used only under the direct supervision

of a licensed physician.

Microsoft Windows 10

is a registered trademarks of Microsoft Corp.

Technical Support

In addition to the information in this manual, more information and help is avail able at our web site: www.nemon.com or
Toll Free USA: 866-346-5837 option 1
Phone: [+1] 978-461-3992 option 1
Fax: [+1] 978-461-5991
e-mail: [email protected]

The “Technical Support” page on the web-site includes
Frequently Asked Questions.

The current version of this manual can be found on our web-site on the “Downloads & Documents” page.
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1 INTRODUCTION

Welcome to NorthEast Monitoring’s LX Event. With LX Event, you can receive ECG recorded events, review the  events, save particular ECG strips of interest, create event or procedure summary reports.

System Requirements

LX Event can be used with NorthEast Monitoring DR400 recorders. To run LX Event, your PC should  include:

1.  dedicated PC for LX Event, Event Decoder and Etel, not to be used for other purposes
2. Microsoft Windows 10 Operating System
3. processor with a speed of 3 GHz or faster
4. at least 16 GB of working memory
5. monitor with a resolution of at least 1280 x 1024
6. disk drive of at least 1 TB HDD or SSD
7. laser printer
8. internet connection with permissions to make FTP transfers

Operator Knowledge

To use NorthEast Monitoring LX Event, you must have extensive ECG knowledge that allows you to properly identify sinus and paced rhythms, abnormal rhythms, supraventricular and ventricular arrhythmias, arti fact, ST segment changes, and pacemaker failures. In addition, all instructions assume a working knowledge  of computers and, specifically, Microsoft Windows operating systems.

User Specifications

LX Event is designed to be used by a trained operator under the supervision of a licensed clinician for the purpose
of evaluating the ECG captured as part of an automatic or manually saved recording event.

LX Event can only be used with a NorthEast Monitoring, Inc. DR400 recorder in Event mode.

Essential Requirements:

Display capability:

1. Display ECG data as individual events.
2. Label recordings made from the NorthEast Monitoring recorders with time, date and event type.
3. Display in a full disclosure in a scale of from 0.25 to 4x normal with from 3.75 to 60 seconds of data per  line of the display.
4. Measure PR, QRS, QT, ST, and HR values  using cursors which can be positioned on the  ECG data.

Recorder capability:

1. Data from recorders can be displayed with all  time, date and event labels.
2. Data transmission method is wireless using the  NorthEast Monitoring Gateway.
3. Maximum recording length: No maximum

Intended Use

The LX Event utility is a data management pro gram intended and designed to be used with the  DR400 recorders for diagnostic evaluation of tran sient symptoms such as dizziness, palpitations,  syncope and chest pain. The system provides sin gle lead or multiple lead ECG morphology, which  may be used to visualize arrhythmias, ST segment changes, SVT, heart block, re-entrant phenomena,  and p-waves. The system may be used with pace maker patients to assess pacemaker activity. The  LX Event Software is to be used only on the order  of a physician.

Indications For Use

The LX Event utility is intended to be used with  the DR400 recorders. LX Event does not analyze  data

Utilities

Physician Edit

You will want to create physician files before you  start adding patients to LX Event. By setting up  physicians, you will able to more easily enter patients when the time comes. In order to do this,  go to Utilities > Physician Edit from the toolbar.

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2 PROCEDURE INFORMATION

When the NorthEast Monitoring Event recorder is given to a patient, a new Procedure should be set up in LX Event.  Because a recorder number can only exist on one procedure at a time, be sure that the previous procedure for that recorder number has been closed before starting a new procedure with the same recorder number.

When the LX Event utility first opens, it displays a blank screen with a standard toolbar. To create  or to work with an existing procedure, select Procedures from the toolbar and choose an option.

Find a Procedure/Patient

Go to Procedures > Find to view Patient List. Use the  Search box at the top of the screen to search any of  the visible items to find your patient.

To View only inactive procedures, click on the “Show  Closed Procedures” box at the bottom. Scroll to the right to see additional items on the Procedure List.

The Last Event value on this list, which does not  appear in the Patient Information, is updated by the system each time a new event is saved for a patient.

Open a patient by highlighting the line and clicking OK or by double-clicking on the line.

From this screen you can also delete patients. The system will ask you to confirm deleting by typ ing DELETE to ensure that you are sure you want to delete the selected patient.

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LX Event User’s Manual New and Patient Info screen

New and Patient Info screen

To create a new patient, go to Procedures > New. The Patient  Information window will open  and enter the new procedure information at this time.

If a procedure is already opened,  view the current patient information by going to Procedures >  Patient Info. You can update that  information at any time.

LX Event requires a Patient to have a Name, an Enrolled Date and a Recorder ID, but we recommend that you also enter the  Patient DOB, Phone and Referring Physician at a minimum.  Once you are finished entering a  new patient, press OK to accept/save or Cancel to exit without saving.

Patient Dates

Enter a date by manually typing or using the calendar.

If you know the patient’s Date of Birth – DOB – you  can enter it and the age will automatically be calculated. You can just enter the age if the date of birth is  unknown.

The Enrolled Date/Time is the start date of the procedure – when the patient is instructed to begin wearing the event recorder. LX Event will default to midnight, 12:00 am, but if you have more than one  patient wearing the same recorder on the same day,  you may want to specify the exact time that the recorder was assigned to the current patient. Do this  by clicking on the down arrow next to the date.

The Due Back Date is the entered when the procedure has started. It is the date that you expect the  procedure to end.

The Procedure Closed Date is filled in once the  recorder has been returned. Once a procedure has  Closed Date, you can no longer save new events for  the procedure. The Technician field should be filled  in at this time.

Indications and Medications

Each field has a drop-down box where you can select  one or more entries. You can also edit the field  directly and add or modify what you have entered.

The Recorder ID

Enter the SN number that is found on your recorder.

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LX Event User’s Manual Network Installations

Status

At the bottom of the Patient Information win dow, you can update the patient’s status by  clicking on the Edited, Reported, or Verified  buttons. The status fields are visible from the  Patient Found List.

Summary

View the Summary Screen for the currently  opened Procedure.

Exit Procedure

Close the current procedure by going to Proce dures > Exit Procedure.

Network Installations

The lxevent.ini file located in your installation  points to member, provider and other directories. You can customize this file for your pur poses as follows:

IncomingFilesDirectory=c:\nm\ftp. Tells the  Incoming Files window where the “Event”  folder is located. This is where the wireless  files should be saved.

PatientDataDirectory=c:\nm\patients\. The  default is on the c: drive, but you can denote a  shared directory for network installations.

PhysiciansDataDirectory =c:\nm\lxevent\Physicians\ The default  is on the c: drive, but users can share a single  directory for network installations.

Customizing Lists

Lists for medications, indications, diaries and  strip labels can be found in the c:\nm\lxevent  directory in a typical installation.

To share these lists, you will need to copy them  to each PC. If you customize these lists, you  may want to make a copy and save it elsewhere  as when and if you update LX Event, your  updated lists may get replaced.

Back-up Procedure Data

It is highly recommended that you back-up and  save your procedure files separately from your  computer on a regular basis. On a typical  installation, the Patients directory is found in  c:\nm\patients.

Archiving Procedure Data

Data for each procedure is stored in a folder  that can be found in the folder name of the  year, month and day that the procedure was  created. Additionally there is a NMPatients.csv  file in the patients folder that acts as the direc tory for the Patient List in LX Event.

When LX Event is not running, you can  archive patient data, by copying and then delet ing any year and/or month folder from the  Patients folder. To correct the directory file,  you will then need to delete the NMPa tients.csv file so that it can be rebuilt the next  time LX Event is started.

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3 SAVING EVENTS AND CREATING STRIPS

A patient must have an open Procedure – a record with no Procedure Closed Date – in order to  receive a new event. A procedure may consist of one or more events and you can continue  receiving new events for a patient until a Procedure Closed Date is entered onto the Procedure.  If a procedure is closed and a new event has arrived, you can either:

• Open a new Procedure for the patient, or
• Remove the Procedure Closed Date from the patient’s last record in order to re-open it.  (This should only be done if the last procedure should not have been closed.)

The DR400 recorders have the capability to send files via the cellphone network using a Gate way. In order to receive these files you must have NorthEast Monitoring’s Event Decoder util ity installed in your facility. Information on how to set up and receive files wirelessly can be  found in the DR400 manual.

Refer to Chapter 5 for more information on using the Incoming Files window.

The Event Screen

A procedure is composed of one or more events. An event is when the patient experienced a  cardiac symptom and either pressed the button or the event was sensed automatically. Settings  that you can adjust are on the top row of the screen:

Gain

To change the amplitude of the displayed signal, click on the Gain field and select a different size from the list.

High Pass Filter

To adjust the High Pass filter, click on the drop-down box labeled HP. This filter will allow you to reduce baseline wander.

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LX Event Operator’s Manual The Event Screen

Low Pass Filter

To adjust the Low Pass filter,  click on the drop-down box labeled LP. This filter will  allow you to reduce muscle noise and electrical artifact.

Invert ECG:

To invert the ECG  signal, check or uncheck the Inverted box.

Sec/Row:

To adjust the amount of time in each row of the  ECG, click on the drop-down box labeled Sec/Row  and choose the amount of seconds in each row.

R-Wave Markers and HR

LX Event attempts to label each R-wave with a red  dot and then calculates the HR based on the RR intervals. The HR calculation has a limit of 180 HR.

Time Date

The time at the beginning of the event.

Event Type

The Event Type initially shows the type of event that was captured by the recorder. You can update the event type to be more accurate once the event is reviewed by you.

The drop-down list  includes MCT (Mobile Cardiac Telemetry)  which is assigned to ECG data that was not necessarily part of an  event, but requested via the ETel utility. You can also relabel and event to “Regular” or “Normal”, if  you choose to do so.

Diary Symptoms

If your patient kept a diary, you may want to enter  any symptoms they were experiencing or what they  were doing at the time of the Event. You can either

select from the drop-down box or add one of your  own.

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LX Event Operator’s Manual Saving Strips

Saving Strips

When an event is open, click on the ECG to identify strips. The blue bull’s eye shows where strips have already  been saved. A red bull’s-eye appears when the corresponding strip appears at  the bottom of the screen. Once the strip appears on the bottom of the screen, you can place cursors, label and save the strip. Once saved, the  bull’s-eye will be blue. Use the Previous and Next Strip buttons to switch between and view or edit  saved strips.

Cursors

The Default Cursors button at the top-left of the  strip allows you to place all of the cursors at once  in a location determined by LX Event. After press ing Default Cursors, you can move any of the single cursors by pressing the button for the that  cursor and then clicking on the screen where you  want it to go.

Apply single cursors by first clicking on the appropriate cursor button. LX Event will then place the  cursor in the default location, and you are able to move it by clicking elsewhere on the screen. Once  the cursor is where you want it, select another but ton to continue.

In order to remove a cursor, click on the button  and then click on the Delete Cursor button.

Strip Measurements

The second row of boxes shows the resulting measurements from cursor placement:

PR: Time difference between Q and P. QRS: Time difference between S and Q. QT: Time difference between Q and T. ST: The vertical difference between the values  of the I and ST cursors.

HR: The heart rate is calculated based on R1  and R2 being 2 RR intervals apart.

XY: X and Y allow you to measure between  any two points on a strip. For screen use  only and will not appear on the strip when  reporting.

Saving and managing strips

If an event is not significant, you can check the  Event Reviewed button to show that it has been  reviewed, without saving any strips.

Strip Label. Every strip must have a label to be  saved. You can use the pre- formatted labels sup plied with LX Event and/or add a label of your  own.

Save Strip. Once you assign all of the cursors, you  can enter a Strip Label and save the strip by press ing the Save Strip button.

Delete Strip. Delete the strip that you are cur rently on.

Strip Notes. Once a strip is saved, a gray Notes  button will appear. Notes entered here will not be  printed on any reports. When Notes exist for a strip, the button will appear green.

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LX Event Operator’s Manual Saving Strips

Save Event as Strips. If you would like an entire  event to be saved as strips, use the Save Event as  Strips button. First click on the Event, then add a Strip Label and then click on Save Event as Strips.  The label will be applied to all of the strips. You can  then go back and edit each strip if desired.

To edit a Strip.  To select a previously saved strip,  use the Previous and Next Strip buttons till the  strip you want to edit appears on the bottom of the  screen. Once the strip appears, you can edit it and  the changes will e automatically applied to the strip.

HR out of range warning

If you attempt to save a strip with a heart rate that is  not valid, LX Event will give you an option to  “CANCEL” saving and correcting R1 and R2 to save the strip with a valid HR, or to save the strip  without an HR. If you click “OK” and the strip is  saved without an HR, it will not appear on the trend that may appear on the report.

The Summary Screen

The Summary Screen allows you to see a summary  list of all events and strips for a procedure in one  location. Events appear in gray, and Strips will appear on white lines. You can go to any event or  strip by double clicking on that line. The “Tech”  column displays the technician who saved the origi nal transmission or file.

Include in Report (Strips)

This box can be used for Strips only. The “Include  in report” check box on the very right is turned on  automatically when you Save or edit an existing strip. When one Strip for a given event is selected,  either manually or by creating a new strip, all strips  within that Event will be included in the report.

You can use the Select/Unselect button at the bot tom of the screen to turn on/off all of the Include in  report buttons for all events for a procedure.

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LX Event Operator’s Manual Saving Strips

When an Event report is generated, the report  process will then turn off the check boxes and  insert the report name that the event was last  included on and the Printed box will be populated for that event.

Check boxes:

There are several additional check boxes on the  Summary Screen that you can use to manage  the procedure as you choose. They are:

Reviewed: This check  box is turned on automatically when the

Event Reviewed box is checked at the bottom  of the screen. This is useful if you decide not to  save strips, but want to show that the Event has  been seen by a technician.

Printed: Once an Event report is created by the  report process, this check box will be popu lated for the Event.

Verified: Manually check this box after a  report is verified and finalized.

Event Report#

This is the file name of the last report that the  strip was included on. Click on the Manage  Reports button at the bottom of the screen to  see a list of all reports that have been created  for the procedure. The reports all end in “.odt”.

You can also create Event or Procedure reports  from the screen. More on that in the next chap ter.

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4 REPORTING

Once strips are saved for one or more events, you can create a report. There are two types of reports: Event and Pro cedure. An Event report will include any strips that you saved since the last report you created for this procedure. A  Procedure report will include all strips that exist for the patient. Findings for each report can be created and saved in  the respective Report windows that can be found on the Summary Screen or Report from the toolbar. Once a report is  created, Libre Office will open and at this point you can edit and save the report.

To Create a Report

Reports can be produced or reviewed at any time. In order to create a report:

1. Open the procedure.
2. Review Events and save strips.
3. Go to Report on the toolbar or the Summary Screen and choose either Event or Procedure  Report.
4. Enter and/or edit findings.
5. Save & Print the report.
6. The report will now open for editing and/or printing. You can also save as a PDF.

Findings

You can enter and save Findings for either the Event of Procedure report at any time. Just enter  the findings and Save until you are ready to create a report. For the Procedure Report only, you  will see a section at the top that is updated and summarizes all of the strips that have been saved up to this point. This section does not appear on the report, but can be utilized to build the findings that you choose to include below.

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LX Event User’s Manual Customizing Reports

Include Strips

This check box is turned on by default.  Uncheck the box to create a one or two page  report with findings only.

Procedure Report Trend

The Procedure Report will include an HR rend  of all strips that were saved during the proce dure. The trend will vary in size based upon the  duration and can be 1, 3, 7, 14, 21 or 30 days in  length. The Max, Min and Mean HR are based  upon the strips that have been saved and the  %strip values are based upon all saved strips.

Manage Reports

All reports that you created previously have  been saved in a directory for that procedure.  All reports are saved with the “.odt” suffix.

From here you can open and edit reports, but  not the strips. If you like you can also delete  reports from this screen, but keep in mind that  the Summary screen will not update automatically.

Note: As of release 3.0.3, all reports are  stored in a directory labeled “reports” off of  the main patient directory. Previously created  reports will still be found in the patients main  directory.

Libre Office

Libre Office is word processor that is included  with the LX Event install. You can use Libre  office, and possibly other word processor, to  edit your reports after they have been created  by LX Event. You will want to save your report  as a PDF file before sending it to its final desti nation.

Customizing Reports

Two files in the Programs Directory can be  updated so that your reports can include your  company’s logo, name and address.

Report Logo

You can include your organization’s logo on  the report. Do this by saving a jpg file, named  logo.jpg, of your company logo in c:/nm/ Lxevent/ directory.

Report Name and Address

Your organization’s name and address and/or  phone can also be added to the report. In order  to do this, you will need to edit a file that  comes with LX Event with the information that  should appear with the report. The file is lim ited to five lines of text.

You should edit the file with Notepad only.  Notepad can be found under All Programs->  Accessories. The file you need to edit is c:/nm/Lxevent/ServiceAddressHeader.ini.

If for some reason you do not want to your  organization’s name to appear at the top of the  report, you should save the file, but it should be  an empty file with all blank lines.

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5 WIRELESS FILES

The Incoming Files window allows you to view all event files that have been received wirelessly via the Event  Decoder utility.

Incoming Files Window

..Upon installation, LX Event will look for incoming  files in c:\nm\ftp\event. To change this location, you  can change the Incoming Files Directory in the  lxevent.ini file to look to a folder in another location where it can find “Event”.

The Incoming Files window automatically matches  new event files to open procedures. The matching  logic requires that you input the Serial Number from the recorder into the Recorder ID on the Patient Information window.

When the Recorder SN on the incoming file matches and open procedure Recorder ID, the Patient Name,

Patient ID and DOB will appear columns to the right  of the Recorder SN.

Assigned Incoming Files

When matched, you can select one or more incoming files, and assign them to the Procedure. The system  will ask you to confirm the assignment as once assigned the file will be automatically deleted from the  incoming files.

If an incoming file is not matching to a patient, you will need to  find the Procedure to identify the problem. Most likely the

Recorder ID and SN do not match and/or the Procedure has an end date and needs to be reopened for matching to take place.

If you get a warning that an event before patient enrolled,  you should verify that the time of the event for this patient is appropriate, or if they event maybe should be assigned instead to the last patient who wore the recorder.

More information on Wireless

Refer to the DR400 and the Gateway-FTP manuals for instructions on running the Wireless feature which  may include MCT (Mobile Cardiac Telemetry). Both manuals can be found at www.nemon.com.

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6 KNOWN ISSUES

The following is a list of issues that have been identified in this or a previous version of LX  Event:

Release

|

Bug

|

Description

|

 Plans to resolve

---|---|---|---

3.0.1

|

 1519

|

 Invert does not work if ECG not clicked on.  Always click on the event before saving strips or  updating the event.

|

This may be fixed in a  future release

3.0.1

|

 1521

|

 Strip values are currently affected if the user  changes the gain.

|

This may be fixed in a  future release

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References

• Holter Monitor - Event Recorder | NorthEast Monitoring

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