Midmark IQholter, IQholter EP, IQholter EX Operation Manual

IQholter®, EX/EP

Version 10.0.0

Operation Manual

39-78-0001 Rev. A

39-78-0001 © Midmark Corporation 2016

Notice

The information in this manual is subject to change without notice.

Midmark Corporation shall not be liable for technical or editorial omissions made herein, nor for incidental or consequential damages resulting from the furnishing, performance, or use of this operation manual.

This document contains proprietary information protected by copyright. No part of this document may be photocopied or reproduced in any form without prior written consent from Midmark Corporation.

IQecg, IQholter, IQspiro, IQvitals, IQmanager, and IQpath are trademarks of Midmark Corporation.

Windows and Microsoft are registered trademarks of Microsoft Corporation in the United States and other countries.

Intel and Intel Core are trademarks of Intel Corporation in the United States and other countries.

Energizer is a registered trademark of Energizer.

Part number: 39-78-0001 Rev A

39-78-0001 © Midmark Corporation 2016

Table of Contents

Related Documents .........................................................................................................6

Precautions .........................................................................................................................7

I. General Information .....................................................................................................8

A. Recorder Description .......................................................................................................8

B. Recorder Specications .................................................................................................10

C. Holter System Description ............................................................................................11

D. Necessary Computer Skills ...........................................................................................11

E. Product Features ............................................................................................................12

F. Contents Checklist ..........................................................................................................13

II. Installation ....................................................................................................................14

A. Minimum Computer Requirements ..............................................................................14

B. System Components ......................................................................................................15

C. Set Up ..............................................................................................................................15

D. Software Installation .......................................................................................................17

E. Conguring IQholter

.....................................................................................................18

III. Patient Preparation ..................................................................................................27

A. Electrode Site Preparation ............................................................................................27

B. Three Channel ECG Recording ...................................................................................29

IV. Recorder Operation ................................................................................................. 31

A. Recorder Set-Up and Conguration ............................................................................31

B. Conrm Operation and Start Recording ......................................................................36

C. Before the Patient Leaves the Ofce ...........................................................................38

D. Early Termination of Recording ....................................................................................39

E. When patient returns with the IQholter® recorder ......................................................39

V. Creating a Holter Report ........................................................................................40

A. Starting IQmanager

......................................................................................................40

B. Reviewing and Editing Holter Tests .............................................................................49

VI. Appendices ................................................................................................................85

A. Appendix A - Operations at a Glance ..........................................................................85

B. Appendix B - Troubleshooting Guides .........................................................................87

C. Appendix C - Maintenance and Storage .....................................................................89

D. Appendix D - Radio and Television Interference ........................................................91

E. Appendix E - Programming the IQholter® Recorder 24+ ..........................................95

F. Appendix F - Safety and International Symbols ..........................................................96

G. Appendix G - Accessories and Supplies .....................................................................97

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VII. Customer Support and Warranty Information ............................................98

VIII. Contact Information .............................................................................................99

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Physician’s Responsibility

The statistical results provided by the Midmark IQholter®, IQholter® EX, or IQholter® EP are for the exclusive use of licensed physicians or personnel under their direct supervision. The numerical and graphical results should be examined with respect to the patient’s overall clinical condition, recording preparation quality, and general recorded data quality, which can affect the accuracy of reported data.

Proper administration of the test is the physician’s responsibility, as is making a diagnosis, obtaining expert opinions on the results, and implementing the correct treatment, if indicated.

Caution

Federal Law restricts this device to sale by or on the order of a physician.

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Related Documents

The following documents may be needed in order to operate Midmark diagnostic devices and software products with the IQholter®:

• IQmanager® Software Operation Manual (Part number: 62-78-0001)

• IQholter® Quick Reference Guide – Patient Preparation (Part number: 39-79-0004)

All documents referenced above are located on the Midmark Operation Manuals CD (part number: 3-100-2000), included with every device. All product Operation Manuals can also be downloaded from

midmark.com. For additional information contact Midmark Technical Service at 1-800-624-8950, option 2.

39-78-0001 © Midmark Corporation 2016

Precautions

Read the following to ensure the proper operation of this instrument:

1. Become familiar with the operational procedures of the IQholter® recorder prior to use.

• Disconnect the recorder from patients during defibrillation.

• The recorder is not designed for sterile use.

• The recorder is not intended for use with rechargeable batteries.

• Recorder maintenance:

− Keep the recorder away from splashing water.

− Do not store or use the recorder where humidity, ventilation, direct sunlight or air containing dust,

salt or sulfur might affect it.

− Prevent the recorder from slipping and protect it from the possibility of vibration, shock or drop;

be particularly careful during transport

− Do not store or use the recorder in a chemical storage ager, or where gas is generated.

• Preparation of the recorder prior to operation:

− Verify proper recorder operation.

− Check that cable connections are secure.

• Precautions while using the recorder:

− Avoid activities that could affect the quality of recorded signals. Do not sleep under an electric

blanket.

− Patients should not shower, take baths, use hot tubs or perform similar activities while wearing

the recorder.

− Keep the recorder and electrode sites dry while in use.

− Do not tamper with the recorder. Do not remove the secure digital (SD) card or battery

until the recording is complete.

• Precautions after using the recorder:

− Remove the battery and SD card.

− Download patient data to computer as soon as possible to preserve patient data.

− Do not reinstall battery into the recorder with the SD card installed. Patient data will be lost.

− Keep the recorder clean to ensure trouble-free operation during next use.

• Perform routine inspection of the recorder and accessories.

• Do not make any modifications to the recorder.

DANGER

Possible explosion hazard if used in the presence of flammable anesthetics.

Caution

Refer servicing to qualified service personnel.

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I. General Information

IQholter® Recorder

A. Recorder Description

The IQholter® recorder is a lightweight, compact, digital Holter recorder designed for reliability and ease of use in ambulatory ECG applications. Because the digital design has no moving parts, the IQholter® recorder records cleaner ECG quality and has lower maintenance cost when compared to tape-based Holter recorders.

The IQholter® recorder can be congured as a 5-lead/3-channel or 7-lead/3-channel recorder by changing the patient cable.

7-lead/3-channel recording is recommended to attain best signal quality.

OLED

An Organic Light Emitting Diode (OLED) display assists Holter technicians in the verication of proper

patient hookup on the spot, eliminating the need for expensive test cable interfaces with ECG machines or connecting to a computer.

Five-Way Navigation Button and Patient Event Button

A ve-way (up, down, left, right, center/enter) button provides intuitive access to the options and menus

within the IQholter® recorder. The center button also acts as a momentary Event button, providing a convenient means of marking and storing event times. Once the Holter data is downloaded and analyzed, ECG strips correlate to the Event (center) button being pressed can be access easily.

Storage Media

Data is conveniently stored on a removable and reusable SD card, eliminating the need for cassette tapes. Digital technology also eliminates tape-based variables such as tape-head frequency, speed variations, distortion and tape brand inconsistencies.

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Removable SD card frees up the IQholter® recorder for next patient without waiting for the recorded data to download.

Note

Midmark only recommends using SD cards issued by Midmark. Using other SD cards may cause recording or download errors and potential loss of test data.

Belt Clip

A repositionable belt clip is available on the back of the IQholter® recorder. For better patient comfort the clip is mounted to the recorder so the recorder rests in a horizontal orientation when attached to a belt.

5-Lead or 7-Lead Cable

Depending on the model purchased, a color-coded 5-Lead or 7-Lead cable comes with the IQholter® recorder.

Note

The 5-Lead and 7-Lead cables require different Holter prep kits. Please contact a Midmark sales representative or call Midmark Technical Service for more information.

7-lead/3-channel recording is recommended to attain best signal quality.

24 Hour Mode or 24, 48, 72 Hour Mode

The IQholter® recorder indicated by 24+ on the serial number label is capable of being upgraded to record 24, 48, or 72 hours in “Hi-Def” mode. See table below. Upgrade kit (1-370-0020) will provide this capability.

Attribute

Standard Mode

(Default)

‟Hi-Def” Mode

(Upgrade kit needed)

Hours of Recording 24 24, 48, or 72

Patient ID Not Available

AlphaNumeric (up to 21 characters)

Sample Rate 128 samples/sec 256 samples/sec

Resolution 8 bits 12 bits

Data Size (per 24 hours) 33 Mbytes 132 Mbytes

Upload Time (per 24 hours) 2 minutes 2 minutes

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Note

Use electrodes that are rated for the timeframe (24, 48, 72 hours) for the patient tests.

Note

Use a lithium battery for 72 hour patient tests.

B. Recorder Specications

IQholter® Recorder Performance Specifications

Category Specification

Intended Use

The IQholter

recorder is intended for the recording of ECG data collected from ambulatory patients. The recorder can collect data in the presence of implanted pacemaker pulses, and can detect and record the occurrence of signals characteristic of pacemaker pulses. The recorder is used under the order of a physician, who reviews the data after downloading and processing by IQholter

program.

PHYSICAL

Weight 2.8 ounces

Dimensions 3.7” x 2.6” x 1.25” (with belt clip) / 1.06” (without clip)

Operating Temperature 0 to 40 degrees Celsius (32 to 104 degrees Fahrenheit)

Storage Temperature 0 to 70 degrees Celsius (32 to 162 degrees Fahrenheit)

Non Operating Shock 1 meter drop (39 inches)

Operating Position Any orientation

Humidity 0% to 90% (non-condensing)

Storage Media Secure digital media card (64MB – 2GB)

FUNCTIONAL

Recording Time 24 hours (Optional 48, 72 hours)

Channels 3

Sample Rate 128 samples per channel/sec (Optional 256 samples per channel/sec)

Resolution 8 bits (Optional 12 bits)

Bandwidth 0.05 to 60Hz -3dB

Input range +/- 5.0 mV

Battery 1 AA, IEC-LR6 – Alkaline for 24, 48; Lithium for 72

Patient Input 5- or 7-lead configuration

CMRR 60 dB

PACE DETECTION SPECIFICATION

Pulse Amplitude (at skin) +/- 2 mV to +/- 500 mV

Pulse Width (at skin) 2ms to 0.1ms

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C. Holter System Description

Note

This manual is intended for IQmanager® users. If using the IQholter

or IQholter® EX/EP through an EMR, please contact Midmark Technical Service for assistance with installation, setup and operation.

IQholter®, IQholter® EX, and IQholter® EP (IQholter® EX/EP) is seamlessly integrated with IQmanager® software, the portal to all of Midmark’s medical diagnostic utilities, including ECG, Spirometry, and Vital Signs. It is designed to scan ECG waveform digitally stored on a secure digital (SD) card by the IQholter® recorder, and to produce an analytical report on arrhythmic cardiac activity. It is a computer-based medical diagnostic instrument designed for use on Microsoft® Windows® 10, 8, or 7, operating systems.

The IQholter® is intuitive and simple to operate. It is designed for clinics that do not see patients with atrial

brillations or pacemakers. The IQholter® EX/EP is developed to allow more interactions from the clinician.

The feature differences between the IQholter®, IQholter® EX, and IQholter® EP are shown in the IQholter® Product Matrix table below.

Holter monitoring is performed for mean heart rate, minimum and maximum heart rates, isolated premature arrhythmia, interpolated ventricular arrhythmia (VE), pairs (VE Pairs), runs of three or more VEs (VE Runs), premature supraventricular isolated ectopic beats (SVE), coupled SVEs (SV Pairs), supraventricular runs

of three or more SVEs (SV Runs), pause, R on T, bigeminy, trigeminy, atrial brillation and ST segment

depressions and elevations for channels 1, 2, and 3. Ventricular Tachycardia (V Tach) episodes are included

in the VE Runs category. Color-coded beat identication enhances the operator’s ability to scrutinize and

validate the computer analysis of the Holter test. Important values are presented in tables and graphics for easy overview.

After the patient’s demographics and recording information are entered in IQmanager®, the Holter program can scan the recorded ECG and automatically generate preselected reports with minimum operator

intervention. The clinician can then review the data, perform editing as needed, produce a nal report,

archive test results for future reference, and share them with colleagues via networks or email.

Note

The IQholter® and IQholter® EX/EP system is designed to scan only ECG data recorded with the IQholter® recorder.

D. Necessary Computer Skills

This manual is intended for a user capable of using Microsoft® Windows®-based applications, has some understanding of PC operations, and is familiar with the basic operations of Windows®.

39-78-0001 © Midmark Corporation 2016

This Operation Manual is a comprehensive guide, designed to educate the user on the operation and functions of the IQholter®, EX, and EP devices. The information in this manual includes all options that are available with IQholter®, IQholter® EX, and IQholter® E P.

E. Product Features

The following table indicates the features available in the IQholter®, IQholter® EX and IQholter® E P.

IQholter® Product Matrix

Feature IQholter

IQholter® EX

(With A-Fib

Analysis)

IQholter® EP

(With Pacemaker

Analysis)

Patient Management Software (Patient Search, Report Sorting, Vitals Trending, etc.)

√ √ √

Network Editing and Reviewing √ √ √

Pacemaker Analysis with Paced Beat Template Editing √

Atrial Fibrillation Analysis √ √

Template Editing for all Categories √ √

User Defined Templates √ √

Individual Beat Editing for All QRS Beats √ √ √

Group Editing for All QRS Beats √ √ √

Inserting or Deleting QRS Beats √ √

HR Variability Analysis - Time and Frequency Domains √ √

HRV Analysis Graphical and Tabular Reports √ √

Output HRV Frequency Analysis Results to Text Files √ √

Automatic 3-Channel QT/QTc Interval Analysis √ √

QT/QTc Trend and Tabular Reports √ √

Automatic 3-Channel ST-Segment Analysis √ √ √

ST Trend and Tabular Reports √ √ √

Page Scan functions √ √ √

Smart Page Scan by Selected Events √ √

Sample Strip Viewing and Editing √ √ √

Heart Rate Trend √ √ √

RR Interval/Ratio Graphs √ √ √

3-Channel Full Disclosure Preview Before Analysis √ √

Automatic Downloading of Patient Events √ √ √

Patient Diary Viewing and Editing with ECG Strip √ √ √

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IQholter® Product Matrix

Feature IQholter

IQholter® EX

(With A-Fib

Analysis)

IQholter® EP

(With Pacemaker

Analysis)

Simultaneous 3-Channel Arrhythmia Analysis √

Automatic Color-Coded Arrhythmia √

Automatic Narrative Summary Report √ √ √

Automatic Artifact Rejection √ √ √

Automatic Printing of Pre-selected Reports √ √ √

Print Selected Hours of Full Disclosure √ √ √

Print ECG strips with colored grid √ √ √

Automatically Saves All Results and Full Disclosure √ √ √

On-line Help √ √ √

Note

For the rest of this manual, unless otherwise specified, all features and functionalities described for IQholter® also apply to both IQholter® EX and IQholter® E P.

F. Contents Checklist

The IQholter® kit (including part numbers: 4-000-0110, 4-000-0113, and 4-000-0116) contains the items listed below. Open the package and account for each item. Inspect them for any signs of damage such as dents, cracks, tears or scratches. If an item is missing or damaged, contact Midmark Technical Service at 1-800624-8950, option 2, for replacement.

Quantity Each Description

1 IQholter

Recorder

1 Patient Cable

1 SD Card

1 Secure Digital Card Reader

1 Reusable IQholter

Recorder Pouch and Belt

1 Software Security Key, USB Version

4 Holter Prep Kits

1 Mouse Pad

1 Training DVD

1 Operation Manual CD

1 Quick Reference Guide

1 Warranty Card

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II. Installation

Note

Contact Midmark Technical Service before installing and setting up the IQholter®. Computers today are more complex with more software and hardware options than before, making each computer almost unique. Midmark wants to make sure that your IQholter® system is installed and configured as quickly and easily as possible.

Midmark Technical Service can be reached at 1-800-624-8950, option 2.

A. Minimum Computer Requirements

This section describes the minimum computer resources and hardware components needed when using new Midmark devices and software. As is the nature of technology to change often, these requirements will

be evaluated and modied periodically. We suggest always referring to the most recent Minimum Computer Requirements document at www.midmark.com, or contact Midmark Technical Service at 1-800-624-8950,

option 2, for additional information.

Note

If updating existing computer systems currently being used with older Midmark devices and software, please contact Midmark Technical Service before doing so.

The IQholter® is a Windows-based medical software program. For successful installation and use of the Holter system, make sure that the host computer meets the minimum requirements and follow the installation instructions carefully.

IQholter® Computer Minimum Requirements

Item Requirement

Operating Systems

Windows

10, Professional and Enterprise, 32-bit and 64-bit

Windows

8, Professional and Enterprise, 32-bit and 64-bit

Windows

7, Professional and Enterprise, 32-bit and 64-bit

Hardware Requirements Windows

compatible personal computer. Desktop model strongly recommended.

CPU

Intel

Core™ 2 Duo Processor E4300 (2M Cache, 1.80 GHz, 800 MHz FSB) (x86)

or 64-bit (x64) processor or faster

Disk 2 GB of free disk space or greater

Memory Minimum 2GB of system memory

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IQholter® Computer Minimum Requirements

Item Requirement

Input/Output Ports

One (1) USB port:

• One Universal Serial Bus (USB) port for the external flash card reader

The flash card reader is required for new test downloads only. An additional USB port is required if a printer is used.

Pointing Device Windows

compatible mouse.

Keyboard Windows

compatible keyboard.

Display

1024x768 or higher resolutions for the real time acquisition screen. 16-bit color. Wide-screen (1680x1050) is highly recommended.

Printer

Microsoft Windows

compatible inkjet or laser printer.

Note: A high-speed laser printer is highly recommended specially for continuous rhythm strip printing.

The above is the minimum computer requirement specication for operating the IQholter® through

IQmanager®. A faster CPU and/or more Memory may be required if planning to operate the IQholter® through an EMR or install additional software.

B. System Components

Figure 1-1 illustrates a general conguration of the IQholter® system. The primary components are a

Windows-based computer, a printer, and the IQholter® recorder.

Figure 1-1 Conguration of the IQholter® System

C. Set Up

1. Remove the IQholter® from its packaging, and verify that all the items are present. See Section I-F,

Contents Checklist.

Note

If using an electronic medical record (EMR) system that does not interact with the IQholter®, the IQmanager® software will need to be installed. Contact Midmark Technical Service to order an IQmanager® software, if needed.

Recorded

memory card

Windows-based

computer

Card Reader

Printer

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Note

A Sentinel Security Key will be included with the device kit. This is NOT a flash drive! Do NOT lose this security key! Contact

Technical Service at 1-800-624-8950, option 2, for any questions about the Security Key.

Note

If using with IQmanager, IQiC, IQiA v.10 or above, or any EMR powered by IQconnect™, please contact Technical Service at 1-800-624-8950, option 2, to discuss exchanging your key for a software security license.

Figure 2-0 Holter Sentinel Security Key

2. If the host computer does not have a SD card reader, install the external USB SD card reader according to the installation instructions included.

3. If using a software security license, add the license to your license server. If using the Sentinel

Security Key (dongle), unpack the key and connect it directly to a USB port on the computer.

Note

Contact Technical Service at 1-800-624-8950, option 2, for any questions about the Security Key or Software Security License

Figure 2-1 Example of USB ports on a computer.

USB Ports

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D. Software Installation

Note

The following software installation information refers to IQmanager

Diagnostic Workstation Software users only. If using

the IQholter

through an EMR, please contact Midmark Technical

Service for assistance with installation and setup.

Note

If IQmanager® is installed on the computer and are upgrading or adding a new Midmark product, please skip this section and refer to the IQmanager® Operation Manual for detailed information on the installation.

Note

Setting up any application in a network environment typically requires administrator privileges, special access rights, and knowledge of the network. Contact the network administrator if you do not have Administrator privileges. The IQmanager® installation program grants all users on the local machine read/ write permissions to the Brentwood folder.

Windows® Taskbar

IQmanager® is designed to run as a full-screen program. For best results, the Windows Taskbar should not be displayed in order to provide maximum display area. Place the mouse pointer on the blank portion of the Taskbar on the bottom of the screen, then right-click and select Properties. Check the Auto-hide the taskbar box to hide the taskbar when it is not in use; to display the taskbar when it is hidden, move the mouse cursor over the area where the taskbar is normally set, and it will reappear.

Installation Steps

Note

Close all Windows programs before installing this software.

Do not interrupt the installation program while it is running. The installation should take less than five minutes.

Note

The Midmark IQholter® requires software to operate. The following instructions use the IQmanager® software. Please contact Midmark at 1-800-624-8950 to purchase the required software license.

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1. Double-click the IQmanager® Isetup file. The installation starts automatically. For any questions on the installation please refer to the IQmanager® Operation Manual.

2. Follow the instructions on the screen. For detailed installation, setup and detailed operation instructions for IQmanager

software, please refer to the IQmanager® Operation Manual.

3. If there are any new licenses, add them to the licensing server. For any questions on adding licenses please refer to the IQmanger

operation manual.

E. Conguring IQholter

IQmanager® and the IQholter® can be customized by using the conguration settings. Access the Conguration Settings by using the following steps:

• Click on the SETTINGS button in the upper right side of the IQmanager® opening screen

The IQmanager Settings window appears:

Complete the Institution Name and Address boxes with information about your medical practice. The IQholter

will print the institution name on the Analysis Summary cover page of the reports. Enter a name

that describes the practice or operation to enable other medical personnel to identify the reports.

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Choose between Metric and English units of measurement, which affect how some of the patient data (e.g., weight and height) is displayed. The IQholter® uses both Date and Time Format settings, but part of the Holter screen will always be in 24-hour format.

The other settings on this screen are irrelevant to Holter. When done, press Save.

Database Settings

Note

Refer to the IQmanager® Operation Manual for customizing the database settings.

The Save Report Location setting determines where the full disclosures and report les will be stored. Each

24-hour Holter ECG le requires 33MB or 132MB (Optional 24, 48, 72) of storage.

List Management

The List Management conguration option customizes the lists used in IQmanager®, including Indications and User Name, which may be used for Holter tests.

Note

Refer to the IQmanager® Operation Manual for information on customizing List Management.

Holter Settings

Change the default settings for Holter tests by clicking Holter Settings from the Devices tab or by clicking Holter Settings inside the Holter program. Both methods provide similar options.

ECG Strips

The ECG Strips tab species how to view or print ECG strips.

If RR Interval is checked, each interval value, in millisecond (ms), will appear on top of the ECG strip between every two RR. If Heart Rate is checked, an instantaneous heart rate value, in BPM, will appear on top of the ECG strip between every two RR.

The Grid option affects the display only; sample strip printouts always have gridlines.

If Beat Annotation is checked, a letter code will appear above each QRS complex indicating its classication. If using a color printer and the Print Color box is checked, the diagnostic ECG strips will be printed with a red grid and all ECG beats will be printed with the following designated color codes:

Beat Category Display Color Beat Annotation

Normal beats Black N

Ventricular beats Red V

Supraventricular beats Blue S

Pause beats Pink P

Artifacts Dark yellow ?

Note

Print Color checkbox only affects the printout if a color printer is used.

Sample Strips

The Sample Strips tab sets the maximum number of sample strips (up to 9) per category for printing, and selects to sort sample ECG strips by time or severity.

Note

High Heart Rate, Low Heart Rate and ST Segment sample strips will be sorted by severity only.

Reports

The Reports tab of the Holter Settings dialog box selects the default reports for printing.

Note

The following reports are only applicable to the IQholter® EX: RR Tachogram, QT Interval Trend, QT Tabular, HRV Summary, Time Domain Analysis, Time Domain Tabular and Frequency Analysis. IQholter® EP offers all reports options including Pacemaker Reports.

Miscellaneous

The Miscellaneous tab provides the option to print ST Summary and Heart Rate Variability summary results on the cover page of Holter report.

If working on a network and the Holter full disclosure is stored on a network drive, check the General box to speed up data access during reviewing and editing. This is useful when operating Holter on a relatively lowbandwidth network, such as a T1 network.

The IQholter

report can be customized to include a logo to the top of cover page. Before clicking on the

Use Customer Logo checkbox, rst prepare a digital image of the logo in jpeg format. Then execute the

LogoSelect application in Brentwood\Program folder and click Find Logo button to pick the logo image.

The logo window is about 7.3” (W) x 1.1” (H). The options available are to keep the original ratio of the

image to t, stretch to t, or scale to a desired size. Use the four grey arrows in the middle to position the

logo inside the window. Click Conrm to save, then Close to exit.

Check the Use Customer Logo box.

QT Analysis

Note

These settings apply only for IQholter® EX and IQholter® E P.

The QT Analysis tab species how the Holter software analyzes QTc intervals. Apply one of the available formulas for QTc analysis; Bazett’s formula is selected by default.

Determine which channel the QT Tabular Report to be based on. This setting will affect online viewing and report printout.

WARNING

Computerized calculation of QTc is not a substitute for physician interpretation of the

Holter. It is the responsibility of a qualified physician to review the ECG to determine the

accuracy of QTc calculation before using QTc to make a diagnosis.

Heart Rate Variability

Note

These settings apply only for IQholter® EX and IQholter® E P.

Only normal RR intervals are used for in the Heart Rate Variability (HRV) analysis. A normal RR interval is

when the current, the previous, and the next QRS waves are classied as normal (i.e. they are not noise or

ectopic beats).

IQholter® provides two HRV analysis domains, Time Domain Analysis and Frequency Domain Analysis. In Time Domain Analysis, the segment size used for calculation is 5 minute.

In the Frequency Domain Analysis, Fast Fourier Transform (FFT) based algorithm is used to estimate the power spectral density (PSD). The segment size for PSD estimation is always 5 minutes, although a longer segment size can be selected for viewing in the setting. If 15 minutes of View Segment Size is selected, the HRV frequency analysis results display will use the average PSD values of three 5-minute segments. For 30 or 60 minutes view segments, the average PSD values of six or twelve 5-minute segments, respectively, will be used.

The Taper Window option determines the windowing formula (Blackman, Exact Blackman, Hamming or Hann) used to calculate power values in different ranges of the frequency domain analysis.

If more than 50 percent of the intervals are invalid in a 5-minute segment, then that segment will be marked as invalid and displayed as “-”.

Pacemaker

Note

These settings apply only for IQholter® EP (Pacemaker Analysis) option.

The Pacemaker tab enables the user to enter or edit pacemaker parameters and settings for analysis and display. At the start of a Holter test, these settings may be customized for each pacemaker patient. All values are optional; the software assigns default values if the parameters are not manually reset. If the Restore pacemaker spikes on ECG box is checked, a red vertical line will appear for each pacemaker spike on the ECG tracing.

III. Patient Preparation

Required Materials

Before beginning the patient preparation, be sure to have a Midmark Holter Patient Preparation Kit or a similar high-quality Holter preparation kit available.

The Midmark Holter Patient Preparation Kit contains:

• 5 or 7 silver chloride disposable electrodes designed for Holter monitoring

• Abrasive pad

• Patient diary

• Isopropyl alcohol wipes

• Razor

• Two (2) AA alkaline batteries

Note

Use one (1) Energizer® brand lithium battery for 72 hour recording to ensure adequate capacity for duration of patient test. This battery is not included in the Midmark Holter Patient Preparation Kit.

Note

Do not use 12-lead resting ECG electrodes. We recommend using the Midmark Holter Patient Preparation Kit for consistent quality ECG data. Use electrodes that are rated for the timeframe (24, 48, 72 hours) for the patient tests.

A. Electrode Site Preparation

Careful preparation of the patient’s electrode sites is essential for obtaining an interference-free ECG and accurate result, especially in Holter monitoring. The skin is naturally a poor conductor of electricity and frequently creates artifact that distorts the ECG signal due to dry or dead epidermal cells, oils, sweat and dirt. Well managed skin preparation, will reduce the resistive barrier that causes muscle noise and baseline wander, ensuring high-quality signal and test data.

Caution

Poor site preparation, improper electrode placement or use of inferior electrodes may lead to unusable data or an inaccurate analysis.

Note

Refer to the IQholter® Quick Reference Guide – Patient Preparation (included in the product kit) for more detailed instructions.

The following steps are essential in obtaining usable ECG data:

1. Select the electrode placement configuration from a reliable clinical reference source. Two typical configurations are illustrated in Figures 3-2 and 3-3.

2. Select electrode sites located over bony areas where reduced tissue movement will minimize the amount of signal artifact. Electrode sites should be over a rib rather than an intercostal space.

3. Shave electrode placement areas, as needed.

4. Gently scrub the skin with an abrasive pad, lint-free gauze pad or fine sandpaper enclosed in the preparation kit. This loosens and removes dead skin.

5. Wipe the scrubbed area with a clean alcohol pad and ensure the entire electrode site is free of oil. Repeat for all sites. Allow these areas to air dry naturally before attaching electrodes.

6. Follow the electrode manufacturer’s application instructions when applying snap leads to the electrodes. To simplify this process, first apply the lead wire snaps to the electrodes then apply the electrodes to the patient.

7. Remove the backing from a pre-gelled disposable electrode and place an electrode on each of the prepared electrode sites, make certain that the right colored lead is placed on the proper site. Ensure that the gel in the center of each electrode maintains contact with the prepared skin surface and the electrode is not wrinkled.

8. Form a stress loop with each electrode lead then tape the loop to the skin. This reduces artifacts caused by snap rotation when leads are pulled or tugged by normal patient movements.

Figure 3-1 Examples of stress loops

Electrodes

Tape

Stress loops

B. Three Channel ECG Recording

• 5-lead Holter recordings

Utilize a bipolar lead system that shares either positive or negative leads between the channels and a recorder ground.

• 7-lead Holter recordings

Utilize a bipolar lead system where there is one positive and one negative lead for each channel, plus a recorder ground.

Five Lead Wire Configuration

Lead Color Placement

Red

Channel 1 (-), Channel 2 (-) Place at center of manubrium and top of sternum.

White

Channel 3 (-) Place on the right side, below the V1 or V3R position, at the bottom of the rib cage.

Brown

Channel 1 (+) Place on the left side at or below the V3 position, on a rib.

Black

Channel 2 (+), Channel 3 (+) Place on the left side at or below the V5 position, on a rib.

Green

Ground Place on the right side, opposite and below the V5 position.

Note

RED (-) BROWN (+) = CHANNEL 1 RED (-) BLACK (+) = CHANNEL 2 WHITE (-) BLACK (+) = CHANNEL 3

Figure 3-2 Typical three channel ve lead electrode placement conguration

RED

CHANNEL 1-2-

BROWN

CHANNEL

BLACK

CHANNEL

2+, 3+

GREEN

GROUND

WHITE

CHANNEL 3-

Seven Lead Wire Configuration

Lead Color Placement

White

Channel 1 (-) Place at top of sternum.

Red

Channel 1 (+) Place on the left side at or below the V3 position, on a rib.

Black

Channel 2 (-) Place at top of sternum, adjacent to white lead.

Brown

Channel 2 (+) Place on the left side at or below the V5 position, on a rib.

Blue

Channel 3 (-) Place at top of sternum, adjacent to white lead.

Orange

Channel 3 (+) Place on the right side at or below the V1 or V3R position, on a rib.

Green

Ground Place on the right side, opposite and below the V5 position.

Note

WHITE (-) RED (+) = CHANNEL 1 BLACK (-) BROWN (+) = CHANNEL 2 BLUE (-) ORANGE (+) = CHANNEL 3

Figure 3-3 Typical three channel, seven lead electrode placement conguration

BLUE

CHANNEL 3-

RED

CHANNEL 1+

BROWN

CHANNEL 2+

GREEN

GROUND

BLACK

CHANNEL 2-

WHITE

CHANNEL 1-

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