Welch Allyn CardioPerfect Workstation User Manual

CardioPerfect Workstation
Resting ECG Module - User Manual
Welch Allyn
4341 State Street Road Skaneateles Falls, NY 13153-0220 USA www.welchallyn.com
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CardioPerfect Workstation
Resting ECG Module - User Manual
Caution
US Federal law restricts this device to sale by or on the order of a physician.

Copyright

© Copyright 2012, Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual. Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of Welch Allyn to provide accurate and up-to-date information to users and operators alike.
Welch Allyn®, CardioPerfect® Workstation and SpiroPerfect® are registered trademarks of Welch Allyn.
Software in this product is Copyright 2012, Welch Allyn. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software provided on the original distribution medium. The software may not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title and ownership of the software remains with Welch Allyn.
The information contained in this manual is subject to change without notice. All changes will be in compliance with regulations governing manufacture of medical equipment.

User responsibility

This product is designed to perform in conformity with the description thereof contained in this manual and accompanying labels and inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. A defective product should not be used. Parts that are broken, plainly worn, missing or incomplete, distorted or contaminated should be replaced immediately. Should any repair or replacement become necessary, we recommend that service be performed at the nearest approved service center. The user of the product shall have the sole responsibility for any malfunction, which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than Welch Allyn or their authorized service personnel.

Accessories

The Welch Allyn warranty can only be honored if you use Welch Allyn approved accessories and replacement parts.
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Caution
Use of accessories other than those recommended by Welch Allyn may compromise product performance.
USA
1-800-535-6663
Canada
1-800-561-8797
Latin America
(+1) 305-669-9003
South Africa
(+27) 11-777-7555
European Call Center
(+353) 46-90-67790
Australia
(+61) 2-9638-3000
United Kingdom
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(+33) 1-55-69-58-49
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(+49) 695-098-5132
China
(+86) 21-6327-9631
Netherlands
(+31) 202-061-360
Sweden
(+46) 85-853-65-51
Note
Welch Allyn does not accept returned products without an RMA.

Warranty, Service, and Spare Parts

Warranty

All repairs on products under warranty must be performed or approved by Welch Allyn. Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty, any product repair shall exclusively be performed by Welch Allyn certified service personnel.
Assistance and Parts If the product fails to function properly or if assistance, service, or spare parts are required, contact the nearest Welch Allyn Technical Support Center.
Before contacting Welch Allyn it is helpful to attempt to duplicate the problem and to check all accessories to ensure that they are not the cause of the problem.
When calling, please be prepared to provide:
Product name and model number and complete description of the problem The serial number of your product (if applicable) The complete name, address and phone number of your facility For out-of-warranty repairs or spare parts orders, a purchase order (or credit card) number For parts order, the required spare or replacement part number(s)
Repairs If your product requires warranty, extended warranty, or non-warranty repair service, please call first the nearest Welch Allyn Technical Support Center. A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone, avoiding potential unnecessary return.
In case the return cannot be avoided, the representative will record all necessary information and will provide a Return Material Authorization (RMA) number, as well as the appropriate return address. A Return Material Authorization (RMA) number must be obtained prior to any return.
Packing Instructions If you have to return goods for service, follow these recommended packing instructions:
Remove all hoses, cables, sensors, power cords, and ancillary products (as appropriate)
before packing, unless you suspect they are associated with the problem. Wherever possible use the original shipping carton and packing materials. Include a packing list and the Welch Allyn Return Material Authorization (RMA) number.
It is recommended that all returned goods be insured. Claims for loss or damage to the product must be initiated by the sender.
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WARNING
The CardioPerfect devices are an integral part of a personal computer based diagnostic system. The user shall adhere to warnings in order to ensure safe and reliable performance of the system.
The personal computer (non-medical electrical equipment)
shall be situated outside the patient environment (reference IEC 60601-1-1).
The personal computer used should be approved to the
appropriate safety standard for non-medical electrical equipment (IEC 60950, or its national variants), and use of an isolation transformer is recommended.
If there is a requirement for the personal computer to be situated within the patient environment it is the responsibility of the user to ensure the system provides a level of safety that ensures
compliance with IEC 60601-1.

Limited Warranty Statement

Welch Allyn, Inc. warrants that the Welch Allyn CardioPerfect Workstation computer based product you have purchased meets the labeled specifications of the Product and will be free from defects in materials and workmanship that occur within 1 year after the date of purchase. Accessories used with the Product are warranted for 90 days after the date of purchase.
The date of purchase is: 1) the date specified in our records, if you purchased the Product directly from us, 2) the date specified in the warranty registration card that we ask you to send to us, or 3)
if you don‟t return the warranty registration card, 120 days after the date on which the Product
was sold to the dealer from whom you bought the Product, as documented in our records. This warranty does not cover damage caused by: 1) handling during shipping, 2) use or
maintenance contrary to labeled instructions, 3) alteration or repair by anyone not authorized by Welch Allyn, and 4) accidents.
You assume all responsibility for use of the Product with any hardware or software that does not meet the system requirements described in the Product documentation.
If a Product or accessory covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period described above, Welch Allyn will, at its discretion, repair or replace the defective Product or accessory free of charge.
You must obtain a return authorization from Welch Allyn to return your Product before you send it to Welch Allyn‟s designated service center for repair.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN'S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THE WARRANTY.
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Table of Contents
1. GETTING STARTED .................................................................................. 8
1.1. The Welch Allyn CardioPerfect resting ECG window ......................................... 8
2. RECORDING ECGS ................................................................................. 10
2.1. Record an ECG ............................................................................................... 10
2.2. Place electrodes on the patient ........................................................................ 10
2.3. Create a new ECG ........................................................................................... 12
2.4. Select how you want to view leads ................................................................... 13
2.5. Set a rhythm strip ............................................................................................. 13
2.6. Turn pacemaker on and off .............................................................................. 13
2.7. Apply an AC filter ............................................................................................. 13
2.8. Apply a muscle noise filter ............................................................................... 14
2.9. Record an ECG ............................................................................................... 14
2.10. Recording rhythm ECGs .................................................................................. 14
2.11. Cancel a recording ........................................................................................... 15
2.12. Pacemaker pulse detection ................................ .............................................. 15
2.13. Signal quality indication ................................................................................... 16
3. RECORDING ECGS FOR PEDIATRIC PATIENTS .................................. 18
4. VIEWING ECGS ........................................................................................ 20
4.1. View and edit ECG information ........................................................................ 20
4.2. Views ............................................................................................................... 21
4.3. Parameters ...................................................................................................... 24
4.4. QTc .................................................................................................................. 24
4.5. QT dispersion (optional) ................................................................................... 25
4.6. Working with views .......................................................................................... 26
4.7. Zoom in and out on an ECG ............................................................................ 26
4.8. Set chart speed and sensitivity ........................................................................ 27
4.9. View one single complex or loop ...................................................................... 27
4.10. Turn pacemaker on and off .............................................................................. 27
4.11. Apply muscle noise filter .................................................................................. 27
4.12. Apply AC filter .................................................................................................. 28
4.13. Apply baseline filter ................................................................ .......................... 28
4.14. Apply anti-aliasing ............................................................................................ 28
4.15. Make measurements ....................................................................................... 29
4.16. Compare ECGs ............................................................................................... 29
4.17. Display markers ............................................................................................... 30
5. INTERPRETING ECGS............................................................................. 31
5.1. About MEANS and PEDMEANS interpretation software .................................. 31
5.2. Edit and confirm an interpretation .................................................................... 31
5.3. View interpretation history ................................................................................ 33
5.4. Reanalyze an ECG .......................................................................................... 33
6. PRINTING ECGS ...................................................................................... 34
6.1. Print an ECG ................................................................................................... 34
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6.2. Automatically print an ECG .............................................................................. 34
7. MAINTAINING THE RECORDER ............................................................. 35
7.1. Cleaning the Patient cables and PC interface cables ....................................... 35
7.2. Replace the battery of the recorder ................................ .................................. 35
8. CUSTOMIZING THE RESTING ECG SOFTWARE .................................. 39
8.1. General tab ...................................................................................................... 39
8.2. Viewing tab ...................................................................................................... 40
8.3. Printing tab ...................................................................................................... 40
8.4. QT dispersion tab ............................................................................................ 41
8.5. Recorder Tab ................................................................................................... 42
8.6. Customize ecg.txt ............................................................................................ 42
9. TROUBLESHOOTING .............................................................................. 43
10. FUNCTION KEYS ..................................................................................... 45
11. BEFORE INSTALLING THE RESTING ECG SOFTWARE ...................... 46
11.1. Structure .......................................................................................................... 46
12. INSTALLING THE RESTING ECG MODULE ........................................... 47
12.1. Connecting the RS232 interface ...................................................................... 47
12.2. Connecting the USB interface .......................................................................... 47
12.3. Install the PCI CPCOM card ............................................................................ 48
12.4. Install the PCMCIA CPCOM Card .................................................................... 49
13. SAFETY AND PRECAUTIONS ................................................................ 50
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CardioPerfect Workstation
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Welcome

Welcome to Welch Allyn CardioPerfect Resting ECG, a module of Welch Allyn CardioPerfect Workstation.
With the Welch Allyn CardioPerfect Resting ECG Module, you can record, view and interpret resting ECGs. You can also use it to print ECGs in various formats.
This manual contains specific information about the Resting ECG Module of Welch Allyn CardioPerfect Workstation. For all general information about the workstation software please refer to the Workstation manual, this includes:
- Creating and editing Patient cards
- General information about printing
For further information on installation and configuration please refer to the Installation manual. Detailed information on servicing is described in the Service and Advanced Installation manual.

Intended use

Using the optional ECG module and associated accessories, the user can acquire, view, store, and print ECG waveforms. The ECG module also provides optional algorithms (MEANS) to generate measurements, data presentations, graphical presentations, and interpretive statements on an advisory basis. These are presented for review and interpretation by the clinician.

Indications

Indications for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.

Contraindications

There are no known contraindications for the recording of a resting ECG. Due to summation of leakage currents, it is possibly hazardous to connect several devices to the
patient simultaneously.
Important: A computer generated interpretation cannot replace sound medical reasoning by a trained professional. Therefore, a physician should always review the interpretation.
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Title bar
Search area
Parameters area
Interpretation area
Workspace

1. Getting started

1.1. The Welch Allyn CardioPerfect resting ECG window

This section will guide you around the various parts of Welch Allyn CardioPerfect Resting ECG module.
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Title bar
The title bar displays the name of the program. The title bar contains three buttons that you can use to maximize, minimize and close the Workstation window.
Menu bar
Each menu in the menu bar contains a number of tasks that you can perform with Welch Allyn CardioPerfect. Sometimes, menus are gray. This means that you cannot access that functionality at that particular point, either because it is not available, or because you are not authorized to use it. Each module has its own menu bar.
Tool bar
The tool bar contains buttons that give you easy access to the most common tasks in Welch Allyn CardioPerfect.
Search area
The search area contains search and display functionality that lets you easily retrieve patients and tests. In the search area, you can find a patient, see which tests were recorded for that patient and see the kind of tests that were recorded. You can also create search patterns, an easy way of finding information that you need frequently.
Workspace
The workspace is the core part of Welch Allyn CardioPerfect. It displays the ECG in various formats. These formats, also called views, are each displayed on a separate tab. The workspace is the place where you view, compare and measure ECGs.
Parameters area
The parameters area contains some details of the ECG, such as the age and the heart rate of the patient, and the global measurements for the ECG (P duration, QRS duration, PQ duration, QT duration, corrected QT duration, P-axis, QRS-axis, T-axis and QTd or JTd duration).
Interpretation area
The Interpretation area contains the interpretation (either entered by the physician or generated by MEANS software). It displays the interpretation text and whether the interpretation has been confirmed.
Shortcut menu
In the workspace, you can use shortcut menus to access the most common tasks. You can access these by clicking on the workspace with your right mouse button.
Status bar
The status bar displays the name of the user that is currently logged on to Welch Allyn CardioPerfect.
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2. Recording ECGs

2.1. Record an ECG

Welch Allyn CardioPerfect records ECGs fast, easily and reliably. The only thing you have to do is make sure the electrodes are placed correctly and switch on the recorder. Welch Allyn CardioPerfect takes care of recording, making a number of measurements and calculations, saving the recording and providing a first interpretation.
To record an ECG, you need to follow these global steps. Each step is explained in more detail on the following pages.
1. Place electrodes on the patient.
2. Select or create a patient.
3. Create a new ECG. The Real-time monitor is displayed.
4. Switch on the recorder. If a PRO recorder with USB cable is used no message will appear, the recorder will be switched on automatically. The Real-time monitor displays the ECG traces.
5. Select how you want to see leads and set a rhythm strip.
6. If necessary, apply an AC filter to remove possible noise that is due to AC mains interference.
7. In the Real-time monitor, wait until the signal is stabilized and click the Record button to start recording. The progress of the recording is shown in the gauge at the bottom of the window.
8. When the recording is finished, Welch Allyn CardioPerfect will ask you to switch off the recorder. If a Pro recorder with USB connection is used the recorder will be switched off automatically, no message appears. Welch Allyn CardioPerfect automatically saves the ECG and calculates the averaged complexes.
9. Disconnect the patient. The recorded ECG is automatically displayed.

2.2. Place electrodes on the patient

Important: Because Welch Allyn CardioPerfect is a 12 lead electrocardiograph all electrodes
must be connected! Proper skin preparation (abrasion if necessary) and proper electrodes are very important for a good signal quality.
Important: When you connect the electrodes to the patient, make sure that the electrodes and their connectors (also the RL/N electrode) do not contact other conducting parts (including earth).
Extremity electrodes
The electrodes may be placed on any part of the arms or the legs as long as they are below the shoulders in the former and below the inguinal fold anteriorly and the gluteal fold posteriorly in the latter. Any other placement necessary by deformed or missing extremities must be noted on the record.
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AHA
IEC
V1
Fourth intercostal space at the right border of the sternum.
C1
V2
Fourth intercostal space at the left border of the sternum.
C2
V3
Midway between locations V2 and V4.
C3
V4
At the mid-clavicular line in the fifth intercostal space.
C4
V5
At the anterior axillary line on the same horizontal level as V4.
C5
V6
At the midaxillary line on the same horizontal level as V4 and V5.
C6
RA
Right arm
R
LA
Left arm
L
RL
Right leg
N
LL
Left leg
F
LL
V1 V2 V3 V4 V5 V6
RA
LA
RL
N
F
C1 C2 C3 C4 C5 C6
R
L
Precordial electrodes
Connect the precordial electrodes in the following positions:

Reusable Electrodes

Each electrode must be attached securely. The electrode paste, gel, or cream must cover an area the size of the electrode, but must not extend beyond it, especially on the chest.
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Caution
Never mix reusable and disposable electrodes on the same patient.

Disposable Tab Electrodes

Disposable electrodes have conductive material on the adhesive side only. The electrode tab must be placed between (clip) or on (banana or pushbutton) the electrode adapter, and remain flat. Do not attempt to place the electrode adapter so close to the circular part of the electrode that the tab of the electrode is bent, or contact is made with the conductive gel. Gently tug on the electrode adapter to ensure that the electrode adapter is properly placed on the electrode. Good and accurate placement of each electrode on the first attempt is important. Each time an electrode is lifted off the skin and reattached, the adhesive gel becomes less effective.

2.3. Create a new ECG

To create a new test:

1. Select the patient. See the CPWS Workstation manual for details.
2. In the File menu, point to New and click ECG. The New ECG dialog box is displayed.
3. In the New ECG dialog box, select the Name and the Specialty of the Referring physician and/or the name of the Ordering physician, and select the lead set that you want to use for the ECG.
4. Click the OK button. The Real-time monitor is displayed. Here you can adjust your view settings and start recording the test.
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5. When you are prompted to do so, switch on the recorder. The Pro recorder is switched on automatically. The Real-time monitor displays the ECG traces.

2.4. Select how you want to view leads

Once you have created a new ECG, the Real-time monitor displays the ECG traces. Before you start the actual recording, you can select how you want to view the traces. Welch Allyn CardioPerfect offers three different views: 1x12, 2x6 and 4x3. In addition, you can set different chart speeds and different sensitivities.

To select a different view:

In the Real-time monitor, select a view from the list. The new view is immediately
displayed.

To select a different chart speed or sensitivity for the view:

In the Real-time monitor, select a chart speed or sensitivity from the list. The speed and
sensitivity are immediately displayed.

2.5. Set a rhythm strip

As a default, Welch Allyn CardioPerfect uses lead II as a rhythm strip, but you can set any lead as a rhythm strip.

To set another lead as a rhythm strip:

In the Rhythm strip pane, select a lead from the list. The new lead is immediately used as
a rhythm strip.

To set the speed and the sensitivity of the rhythm strip:

In the Rhythm strip pane, select a speed and sensitivity. The new speed and sensitivity
are immediately used.

2.6. Turn pacemaker on and off

ECG traces can contain artificial pacemaker signal indicators. You can remove this artificial pacer indicator by disabling the "Show Pacer" selection. To learn how, see Customizing the Resting ECG software on 39.

2.7. Apply an AC filter

ECG traces can contain noise that is due to AC mains interference. This makes the traces harder to read. You can filter out noise by applying an AC filter. When you apply a filter, the original ECG signal is not permanently changed. You only change the way it is displayed on the monitor. You can always restore the original signal.

To apply an AC filter:

At the top of the Real-time monitor, click AC filter. Click again to switch the filter off.
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2.8. Apply a muscle noise filter

Muscle noise in an ECG signal hides low amplitude signals that may be important for the interpretation of an ECG. You can remove this noise with a muscle noise filter.

To apply a muscle noise filter:

At the top of the Real-time monitor, click Muscle filter. Click again to switch the filter off.

2.9. Record an ECG

You are now ready to record the ECG. To record an ECG:
1. In the Real-time monitor wait until the signal is stabilized and click the Record button to
start recording. The progress of the recording is shown in the gauge at the bottom of the window.
2. Next see §2.1follow steps 8-9.

Create a pretriggered recording

When you want to catch a particular event, such as arrhythmia, without having to record an entire ECG, you can use a pretriggered recording. When you start a pretriggered recording, it includes the five seconds before and after you clicked on the Record button. This means that when you see an event and click the Record button, your recording includes the event, five seconds before the event, and five seconds after the event.
The pretriggered option is also convenient when you have difficulties recording an ECG with clean traces, for example because the patient has muscle spasms. The pretrigger option helps defining the 10 seconds of recording by already saving 5 seconds of possibly clean traces.
To create a pretriggered recording:
1. Create a new test and switch on the MD or Portable recorder, the Pro is switched on
automatically. The Real-time monitor is displayed.
2. In the Real-time monitor, click the Pretrigger option.
3. Wait until you see the event that you want to record.
4. As soon as you see the event, click the Record button. Welch Allyn CardioPerfect will
continue recording for five more seconds.
5. Next see §2.1 follow steps 8-9.
6. The recorded ECG is automatically displayed, including the event that you wanted to
capture.

2.10. Recording rhythm ECGs

The procedures for recording a rhythm ECG are almost identical to those for recording a regular ECG. If you need any detailed help with the steps that follow, please refer to section 2.1.

To record a rhythm ECG:

1. In the Real-time monitor wait until the signal is stabilized and click the Rhythm button to
start recording. The progress of the recording is shown in the gauge at the bottom of the
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window.
2. Next see §2.1 follow steps 8-9.

Capture an event

When you notice an event, like arrhythmia, during recording, you can capture this in the ECG. When you do this, a small exclamation mark is inserted at the place where the event occurred.
To capture an event, click the Event button.

2.11. Cancel a recording

You can cancel a recording at any time in the recording process.

To cancel a recording:

Click the Cancel button in the Real-time monitor. The recording is cancelled and you
are asked to switch off the recorder. The test is not saved.

Tips for canceling a recording:

When you have not yet recorded 10 seconds of regular ECG, you can also cancel the
recording by clicking the Record button.
You can choose to record a regular ECG or a rhythm ECG without leaving the real-time
monitor.

2.12. Pacemaker pulse detection

The Welch Allyn CardioPerfect software is able to display pacemaker pulse spikes detected by the hardware. These spikes are marked with a symbol in the Real time monitor, in Review mode and on printouts.
When the Pacemaker pulse detection is on, the detected spikes are marked on the trace, as shown here. To learn how to disable this function to remove artificial pacemaker signal indicators, see Customizing the Resting ECG software on 39.
Pacemaker markers
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Square waves
Warning in red Override

2.13. Signal quality indication

If Welch Allyn CardioPerfect Workstation finds the signal from one of the channels to be erroneous, for example caused by a disconnected electrode, the monitor will display “Bad signal on…”. The trace shows square waves, see example below.
Please check the indicated electrodes/channels immediately!
The status information is saved with the test. Erroneous leads will show square waves on both the Review and the printout. Depending on the duration of the erroneous signal no interpretation or measurement will be possible and therefore will not be shown.
In the few moments between a lead being disconnected and that event being detected by the software, pacemaker spikes may be erroneously detected. As a result, a group of pacemaker markers may be shown on the trace just before the square waves are shown. The pacemaker pulse detection will be suppressed as soon as the square waves are shown, and will continue to be suppressed until the erroneous signal is corrected.
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Leadoff, Framing Errors and DCOffset conditions:
If the application detects a Lead-off, DC offset, or Framing error within 10 seconds after you have started an ECG recording, the recording automatically restarts. In the case of a Leadoff condition, the ECG recording will not start until the signal is stabilized. The progress bar of the recording will remain at 0 until all the signals are of acceptable quality.
You can use the override button to disable the automatic restart. DCOffSet The DCOFFSET DETECTED! message displays in the progress bar when
battery power is interrupted or when there is a spike in voltage. Framing Errors Framing errors display in the progress bar and can occur in CPWS
configurations when the Pro recorder is connected via a serial cable and the packets of information are delayed.
Leadoff The Leadoff message displays in the workspace when an electrode is disconnected. The real-time monitor will display “Bad signal on…”. The trace shows square waves until the signal is stabilized.
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