Midmark IQecg User manual

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IQecg®

OPERATION MANUAL

Version 8.6.1

IQecg® Operation Manual

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 guide.

This document may contain 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, IQstress, IQmanager, and IQpath are trademarks of Midmark Corporation. Microsoft and Windows 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. Citrix, ICA, and XenApp are trademarks of Citrix Systems, Inc. and/or one or more of its subsidiaries, and may be registered in the United States Patent and Trademark Office and in other countries. Cidex is a registered trademark of Advanced Sterilization Products, Division of Ethicon Inc., a Johnson & Johnson company. Sani-Cloth is a registered trademark of PDI.

Part Number: 3-100-1115 Rev. C

TABLE OF CONTENTS

IQecg® Operation Manual

RELATED DOCUMENTS ............................................................................................... 1

PRECAUTIONS ............................................................................................................ 2

CONTENTS CHECKLIST ................................................................................................. 3

A. B. C.

GENERAL INFORMATION ............................................................................... 4

NTRODUCTION

ECESSARY COMPUTER SKILLS

ONFIGURATIONS

.......................................................................................................... 4

...................................................................................... 5

...................................................................................................... 5

Typical PC Configuration ....................................................................................... 5

Thin Client Configurations .................................................................................... 5

Thin Client Using the IQpath™ Software Solution ................................................ 6

Thin Client Using COM Port Mapping ................................................................... 7

YSTEM SPECIFICATIONS

.............................................................................................. 9

Modulating Effects ............................................................................................... 9

II.

A. B.

SYSTEM INSTALLATION ............................................................................... 10

INIMUM COMPUTER REQUIREMENTS

OFTWARE INSTALLATION

.......................................................................................... 11

........................................................................ 10

Windows Taskbar ............................................................................................... 12

Screen Saver ........................................................................................................ 12

Installation Steps for IQmanager® ..................................................................... 12

ONNECTING THE IQECG® MODULE

............................................................................ 12

Connecting the Serial-Type IQecg® Module ....................................................... 12

Connecting the USB-Type IQecg® Module .......................................................... 14

ONFIGURING IQECG

® ............................................................................................. 14

Configuring for Serial-Type IQecg® Module ....................................................... 15

Configuring for USB-Type IQecg® Module .......................................................... 15

Thin Client Channel Setting ................................................................................. 16

Database Settings ............................................................................................... 16

List Management ................................................................................................ 16

ECG Statements tab ............................................................................................ 18

User Names tab .................................................................................................. 21

ECG Settings ........................................................................................................ 22

ECG Lead Group .................................................................................................. 23

Printer Settings ................................................................................................... 27

RR Variability Setting .......................................................................................... 29

ECG Configuration Setting .................................................................................. 30

III.

A. B.

OPERATION ................................................................................................. 31

NTRODUCTORY NOTES

ATIENT PREPARATION

............................................................................................. 31

Patient Position ................................................................................................... 31

Prepare Patient Skin ........................................................................................... 32

IQecg® Operation Manual

IV.

A. B. C. D. E.

G. H. I.

Electrodes ........................................................................................................... 32

Limb Lead Placement .......................................................................................... 32

Standard 12-Lead Placement (Precordial) .......................................................... 32

Modified 12-Lead Placement (Precordial & Posterior) ....................................... 33

PERATION OF IQECG® WITH IQMANAGER

® ................................................................ 34

Starting the Program .......................................................................................... 34

Opening Screen ................................................................................................... 34

STAT ECG ............................................................................................................. 35

ESTING A NEW PATIENT

.......................................................................................... 36

Live ECG .............................................................................................................. 37

EVIEWING PATIENT REPORTS

.................................................................................... 43

ECG Report Review ............................................................................................. 43

Editing Diagnostic Statements ........................................................................... 45

ECG Report (Details) Review ............................................................................... 47

Serial Comparison ............................................................................................... 53

RR Variability Report Review .............................................................................. 55

ACCESSORIES FOR IQECG® ........................................................................... 58

APPENDICES ................................................................................................ 59

PPENDIX A - OPERATIONS AT A GLANCE – STANDARD

PPENDIX B - OPERATIONS AT A GLANCE – MODIFIED

PPENDIX C - UPGRADING IQMANAGER® SOFTWARE VERSION

PPENDIX D - TROUBLESHOOTING GUIDE

PPENDIX E - MAINTENANCE AND STORAGE OF THE

..................................................................... 65

12-

ECG M

LEAD

ECG ............................... 59

LEAD

ECG ................................ 61

8.5

AND EARLIER

ODULE

................................... 69

................. 63

Preventative Inspection ...................................................................................... 69

Cleaning .............................................................................................................. 69

Storage................................................................................................................ 69

PPENDIX F - MAINTENANCE AND STORAGE OF

10-L

EAD RESTING

ECG P

ATIENT CABLE

....... 70

Instructions for Use ............................................................................................. 70

Cleaning .............................................................................................................. 70

Disinfection ......................................................................................................... 70

PPENDIX G - RADIO AND TELEVISION INTERFERENCE

PPENDIX H -

PPENDIX I - SAFETY AND INTERNATIONAL SYMBOLS

EMC R

EQUIREMENTS FOR THE IQECG

..................................................... 71

® .................................................... 71

...................................................... 76

VI.

A. B.

IQECG® SERVICE MANUAL ........................................................................... 77

NTRODUCTION

HEORY OF OPERATION

........................................................................................................ 77

............................................................................................ 77

10-Leadwire Patient Cable.................................................................................. 78

ECG Buffer Amplifiers ......................................................................................... 78

Instrumentation Amplifiers ................................................................................. 78

Filters and Gain Amplifiers ................................................................................. 79

Analog to Digital Conversion .............................................................................. 79

Microcontroller ................................................................................................... 79

Isolated Serial Interfaces .................................................................................... 80

IQecg® Operation Manual

VII.

VIII.

Lead-Off Detector ............................................................................................... 80

Pacemaker Detector ........................................................................................... 80

DC-DC Power Converter ...................................................................................... 80

YSTEM MAINTENANCE AND OBTAINING SERVICE

CUSTOMER SUPPORT AND WARRANTY INFORMATION ............................... 82

.......................................................... 81

Warranty............................................................................................................. 82

CONTACT INFORMATION ............................................................................ 83

IQecg® Operation Manual

Physician’s Responsibility

The interpretations provided by the Midmark IQecg® are for the exclusive use of licensed physicians or personnel under their direct supervision. Not all ECG abnormalities can be detected by computerized / automated ECG analysis algorithm. The suggested interpretation, including numerical and graphical results, should be examined with respect to the patient’s overall clinical condition.

It is the responsibility of the physician to ensure proper administration of the test, making a diagnosis, obtaining expert opinions on the results, and instituting the correct treatment.

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

 CAUTION: The automated ECG analysis algorithm assumes standard 12-lead ECG

placement. Any deviation from the standard 12-lead ECG placements may affect the accuracy of the automated interpretation.

 CAUTION: Follow standard 12-lead ECG placement when performing a STAT ECG.

Related Documents

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

• IQecg® Quick Reference User’s Guide – Performing a 12-lead Resting ECG Test

(Part number: 3-100-1116)

• IQmanager® Software Operation Manual (Part number: 4-100-1200)

• Setup Manual: Midmark Products over Thin Client using IQpath™ or COM port mapping

(Part number: 3-100-1126)

All documents referenced above are located on the Midmark Operation Manuals CD (part number: 3-100-1000), 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.

IQecg® Operation Manual

Precautions

Read the following precautions to ensure proper operation of the IQecg®.

1. Installation and maintenance of the instrument:

• Install and keep the instrument away from splashing water.

• Do not install the instrument where humidity, ventilation, direct sunlight or air

containing dust, salt, sulfur, etc. might affect it.

• Protect the instrument from shock and vibration while transporting it.

• Do not install the instrument in a chemical storage area or where gas is generated.

2. Preparation of the instrument prior to operation:

• Verify proper instrument operation.

• Check that all cable connections are safe and secured.

• When in use with additional equipment, such as a computer, request the assistance

of personnel familiar with the additional equipment, if needed.

3. Observe the patient and instrument closely during use. If any abnormality is observed,

immediate proper action, such as stopping the operation of the instrument, should be taken for the safety of the patient.

4. Keep the instrument clean to ensure trouble-free operation for the next use.

5. In case of a malfunction, contact Midmark Technical Service at (800) 624-8950, option 2

and describe the problem precisely.

6. Inspect the instrument and accessories regularly.

7. Do not make any modifications to the instrument.

8. Environmental operating limits:

Operation:

• 59 to 95 °F (15 to 35 °C)

• 30 to 75% humidity (non-condensing)

• 760mm Hg +/- 20%.

Storage/Shipping (batteries removed):

• 4 to 120 °F (-15 to 50 °C)

• 30 to 95% humidity (non-condensing)

• 760mm Hg +/- 20%

IQecg® Operation Manual

 DANGER: There is a possible explosion hazard if used in the presence of flammable

anesthetics.

9. The IQmanager® Diagnostic Workstation software and the IQecg® have been tested for

proper function with the Off-The-Shelf (OTS) Operating Systems (OS) specified in this manual. Do not operate the IQmanager® Diagnostic Workstation and the IQecg® with an operating system other than the OTS OS specified. Future releases of currently approved operating systems should not be used until Midmark has had an opportunity to test the IQecg® with them. Before updating your operating system, contact Midmark Technical Service for the latest OTS operating systems information.

 CAUTION: Replace the patient cable with Midmark patient cables equipped with built-in

defibrillation protection. Contact Midmark Technical Service for cable replacement.

 CAUTION: Electronic devices can be damaged by exposure to liquids. Do not use or store

the IQecg® near any type of liquids.

 CAUTION: Contact Midmark Technical Service for any servicing questions.

Contents Checklist

The IQecg® kit 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 1-800-624-8950, option 2, for replacement.

Quantity Each

1 1 1 1 1 1 1 1 1 1

Description

IQecg® Device (data acquisition module) 10-Lead Patient Cable 10-pack Clear ECG Clips 100-pack Disposable EZ-Trode ECG Electrodes Mouse Pad Training DVD Operation Manual CD

Quick Reference Guide Warranty Card Carrying Case

IQecg® Operation Manual

I. General Information

A. Introduction

The information in this Operation Manual is provided for users of ECG models Midmark IQecg® and IQmark® Digital ECG. Future references of IQecg® in this document may include the following part numbers:

Model Connection Device Part Number Kit Part Number

Midmark IQecg®

IQmark® Digital ECG

* No longer in production.

USB 1-100-1325

Serial 1-100-1305* 4-000-0060*

USB 1-100-1320* 4-000-0057*

Serial 1-100-1300* 4-000-0005*

 NOTE: This manual is intended for IQmanager® Diagnostic Workstation software users. If

using the IQecg® through an EMR, please contact Midmark Technical Service for assistance with installation, setup and operation.

The IQecg® is a portable device that converts a supported Microsoft® Windows-based personal computer (PC), be it desktop, laptop, notebook or pen-based, to an electrocardiograph with interpretive capabilities. The device is electronically isolated from the PC and connects to it directly through the USB port or serial port.

Together with IQmanager® Diagnostic Workstation software, the IQecg record 12-lead ECG, interpret them, archive the reports for future reference and share them with colleagues via networks or email. As simple to use as a traditional office ECG device, it features fully integrated PC technology and a host of advanced diagnostic features.

4-000-0061

makes it easy to

IQecg

both are designed for use with a

two AA batteries and

manual is written for both types of modules.

Necessary Computer Skills

for a user capable of using Microsoft® Windows®

some understanding of PC operations, and is familiar with the basic operations of Windows®.

This Operation Manual is designed as a comprehensive guide

the IQ

The block diagram below illustrates

primary components are a Windows

portable computer is recommended if mobility is a consideration.

system

IQecg

a thin client environment, install the software on the Terminal Server and operate

through a thin client terminal.

supports two thin client configurations:

IQpath

latency, limited bandwidth network configurations with Windows

Windows thin client

and connect to client devices via COM port mappin

Operation Manual

IQecg

port type and a USB port type,

type ECG module does not. This

applications, has

educate the user on

device. The information in this manual includes

system.

acquisition module.

Please refer to this diagram

IQecg

Solution and

either USB or serial port versions of the

speed networks, use the

NOTE: There are two types of

module requires

IQecg®

® modules: a serial COM

Windows-based computer. The serial

the USB-

type ECG

This manual is intended

the operation and functions of options currently available with

C. Configurations

Typical PC Configuration

when setting up your IQecg®

, designed to

ecg®

ecg®.

the standard configuration of the IQecg®

-based PC, a printer, and the IQecg®

The

Figure 1-2

Block Diagram for the

system

Thin Client Configurations

If working in the IQecg®

IQmanager® Client using COM port mapping.

™ works with

IQpath™ Software

IQecg® in highclients. For non-

terminals on low-latency high-

serial port versions of the IQecg®

Thin

based PC

Setting up any application in a network environment typically requires special access rights and

knowledge of the network. Please have

IQmanager® to the

office environment.

™

utilizes a dedicated flow control scheme to

operation over

Microsoft Terminal Services:

latency tolerance.

® protocol

No COM port mapping is required.

The USB version of the ECG module is compatible.

Improved device auto

has specific requirements for computer hardware, software and network

performance. System administrators should read

using IQpath

software in a thin client environment.

describes

Windows

IQmanager

software components on each client PC to

for Microsoft Terminal Services

system administrator install and configure

the following advantages over

loss networks

Improvement is approximatel

Setup Manual: Midmark Products

before installing, configuring

this thin client environment, the client

on the terminal server and install one of the following

f using Microsoft Terminal Services

the

IQecg

Operation Manual

Thin Client Using the IQpath

IQpath™ COM port mapping:

• Improved

o Citrix® ICA

tolerance.

•

NOTE: IQpath™

over Thin Client

and using this

The following block diagram computers must be running

Software Solution

provide

high-latency, low-bandwidth, high-

: Improvement is approximately 40-

-configuration and diagnostics.

™ or COM port mapping

IQpath™. In

® 8, or 7:

y 10-to-1 in

-1 in latency

Figure 1-3

To use IQpath™, load

be used for data acquisition:

• IQpath™

: I

(Microsoft RDP).

IQecg® Operation Manual

• IQpath™ for Citrix ICA: If using Citrix® software on the clients and servers.

These software products are provided separately and may be obtained by contacting Midmark Technical Service at (800) 624-8950, option 2.

Once the software is installed on the client server network and computers, IQmanager® must be configured for thin client operation as described in Section II-C Connecting the IQecg®

Module and Section II-D Configuring IQecg®, or refer to the IQmanager® Operation Manual, Section VI-F, Configuring Client Server Networks.

Thin Client Using COM Port Mapping

COM port mapping refers to a configuration in which the ECG device connects to a serial port of the client and the server is configured so that logical COM ports on the terminal server are mapped to the physical COM ports of the client.

If using a non-Windows-based, thin client terminal device on a low-latency, high-speed network use the serial port versions of the ECG device and configure the thin client server for COM port mapping.

 NOTE: In order to use the COM port mapping solution in a thin client environment, the

computer hardware and software as well as the network must meet stringent performance requirements. System administrators must read the document Setup Manual: Midmark Products over Thin Client using IQpath™ or COM port mapping before installing, configuring and using this software in a thin client environment using COM port mapping.

 NOTE: If using wireless in a Thin Client Environment – check waveform to ensure data

integrity.

The following block diagram illustrates the use of the ECG

using COM port mapping:

in this configuration, install

configure the server to map to the COM port on the client terminal.

System administrators should configure the terminal server for COM port mapping as

described in the document entitled

or COM port mapping

in a thin client environment

the terminal server and

Setup Manual: Midmark Products over Thin Clie

Figure 1-4

To use the ECG device

device

IQmanager® on

IQecg

Operation Manual

IQpath™

nt using

IQecg® Operation Manual

D. System Specifications

The following are the physical and performance specifications for the IQecg®:

Category Specification

Intended Use

Physical Characteristics

Anatomical Sites

Safety Parameters

ECG Acquisition

Patient Connection

Monitor

ECG Analysis & Measurement

Printer

Paper

IQecg® Performance Specifications

To provide standard 12-lead resting electrocardiogram recordings.

•

3.5” (88mm) x 5.7” (145mm) x 1.2” (30mm) (W x L x H)

•

10.2oz. (USB-type ECG module without batteries)

•

11.2oz. (serial-type ECG module with batteries)

• Two 1.5V AA alkaline batteries (serial-type ECG module

only 25 hours of “ON” time (serial-type ECG module)

• Noninvasive device, 12-lead electrocardiogram

• Patient electrically isolated from main current supply.

• Patient leakage current not to exceed 10 uA.

• Ground leakage current not to exceed 50 uA.

• 12 leads, simultaneous.

• Input impedance > 100 MegaOhm

• Frequency response 0.05-150 Hz –3 dB

• Sensitivity: 5, 10, 20 mm/mV +/- 5%

• Dynamic range: +/- 10 mV

•

ADC resolution: 13 bits at 2.44 uV/bit

•

Acceptable electrode offset: +/- 300 mV per AAMI and EC11 specifications.

• A/D 500 samples/sec.

•

10-lead patient cable with RFI filter, defibrillator protection and patient isolation.

•

Varies by computer system, minimum 1024 x 768 resolution

•

Midmark 12-Lead Resting Electrocardiogram Analysis Program.

•

Windows-supported ink-jet or laser printer.

•

Plain 8.5” x 11” (Letter size)

Modulating Effects

The digital sampling techniques used by this device and the ashychronism between sample rate and signal rate, may produce a noticeable modulating effect from one cycle to the next. This variation may be particularly noticeable in pediatric recordings. This phenomenon is not entirely physiologic.

IQecg® Operation Manual

II. System Installation

 NOTE: Contact Midmark Technical Service before installing and setting up the

IQecg®. 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 IQecg® device 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 modified 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.

IQecg® Minimum Computer Requirements

Item Requirement

Operating Systems

Hardware Requirements

CPU

Disk

Memory

Input/Output Ports

Pointing Device

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

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

Windows® compatible personal computer.

Intel® Core™2 Duo Processor E4300 (2M Cache, 1.80 GHz, 800 MHz FSB) (x86) or 64-bit (x64) processor or faster

2GB of free disk space or greater

Minimum 2GB of system memory

One (1) USB port or one (1) serial port:

• One Universal Serial Bus (USB) port if using USB version of the IQ product

• One RS-232 Serial Port if using serial port version of IQ product.

The above computer port is required for new test acquisitions. It is not required to review and/or edit a test.

Additional USB ports as needed for keyboard, mouse, printer, etc.

Windows® compatible mouse.

IQecg® Operation Manual

Keyboard

Display

Printer

Surge Protector

Windows® compatible keyboard.

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

Microsoft Windows® compatible inkjet or laser printer.

One (1) hospital-grade power surge protector for the computer system.

 NOTE: The above is the minimum computer requirement specification for operating

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

 NOTE: USB ports/contacts can become worn with repeated use. The IQecg® test may

not function with a worn USB port.

B. Software Installation

 NOTE: The following software installation information refers to IQmanager® only. If

using an IQecg® through an EMR, please contact Midmark Technical Service for assistance with installation and setup.

The medical diagnostic application IQecg® uses IQmanager® to manage patient records. When installing or upgrading the IQecg®, IQmanager® is automatically installed or upgraded accordingly (Refer to the IQmanager® Operation Manual for further information).

Other Midmark products can also be accessed from IQmanager®, such as, IQholter®, IQspiro®, IQstress®, IQvitals®, IQvitals® PC and Weight/Scale Interfaces. Contact the Midmark Sales Department for the latest information on available Midmark products or visit midmark.com.

 NOTE: If IQmanager® is already installed on the computer and are now either upgrading or

adding a new Midmark product, please skip this section and refer to the IQmanager® Operation Manual for installation information.

Before installing IQmanager® on a computer, it is important to understand and carry out the following tasks:

IQecg® Operation Manual

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 cursor over the area where the taskbar is normally set, and it will reappear.

Screen Saver

If a screen saver or any energy saving feature is enabled on the computer, make sure that it does not activate and interfere with data acquisition during patient care. Refer to your computer or software manual for these settings.

Installation Steps for IQmanager®

 NOTE: Close all Windows® programs before running this software installation. Do not

interrupt the installation program while it is running. The installation should take less than five minutes.

1. Unplug all IQ devices from the computer before running the software installation.

2. Insert the IQmanager® Installation CD into the CD-ROM or DVD-ROM drive. The installation

starts automatically. If the installation does not start automatically, double-click My Computer on the desktop and double-click the CD-ROM icon to start.

3. Follow the instructions on the screen. For detailed installation, setup and detailed

operation instructions, please refer to the IQmanager® Operation Manual.

4. Once installation is complete connect the IQecg® module to the computer with the steps

outlined in the following section.

C. Connecting the IQecg® Module

Connecting the Serial-Type IQecg® Module

If using a serial-type IQecg® module, attach the female end of the 9-pin communication cable to any available serial port on the PC (see Figure 2-2 below). Secure the connections with the thumbscrews. Do not over-tighten.

If using a USB port with the serial-type IQecg® module, install the USB to serial port adapter before connecting the IQecg® module to the adapter. Secure the connections with the thumbscrews. Do not over-tighten.

IQecg® Operation Manual

Follow the battery

The battery compartment

 NOTE: Almost all USB to serial port adapters come with specific software drivers that must

be installed prior to use. Before connecting the IQecg® module to any adapter, ensure that all software drivers have been installed according to the manufacturer’s instructions.

Battery Installation for Serial-Type IQecg®

For the serial-type IQecg® module, slide out and remove the battery door underneath the module and install 2 AA batteries (see Figure 2-1 below). Follow the battery positions indicated. Replace the battery compartment door.

orientation icons

Figure 2-1

Patient Cable Installation

Attach the patient cable to the 15-pin connector on the ECG acquisition module:

door flips closed. Insert outer edge first then push down the inner edge.

NOTE: For the USB-type IQecg®, no batteries are required.

Figure 2-2

IQecg® Operation Manual

Connecting the USB-Type IQecg® Module

If using a USB-type IQecg® module, connect it to any available USB port on the computer after IQmanager® is installed. As with other USB devices, Windows will attempt to identify the IQecg® module the first time it connects to it. This may take a few seconds. The USB-type IQecg® does not require batteries as it receives its power from the computer.

D. Configuring IQecg®

IQmanager® and the IQecg® can be customized by using the configuration settings. Access the Configuration Settings by one of the following ways:

Double-click the shortcut installed on the desktop , or Click on the SETTINGS

button in the upper right side of the IQmanager® opening screen .

The IQmanager Configuration Settings dialog box appears:

If the practice name and details were entered during the registration/installation process for IQmanager®, the information will appear here.

If the practice name and details were not entered during the registration/installation process for IQmanager®, enter the information here.

Complete the Institution Name and Institution Address boxes with information about the medical practice. This information will also be displayed on printed reports. Enter a name that describes the practice/location to enable other medical personnel to recognize the origin of the reports.

IQecg® Operation Manual

From the Configuration Settings, the following options can be selected:

1. Metric and English units of measurement

2. AC power source frequencies of 50 Hz or 60 Hz. o The IQecg® uses the information to filter out background noise

introduced by the power source through its AC filter. In the United States, this frequency is 60 Hz. If using this product outside of the United States, please consult with the local power utility company to determine the appropriate frequency.

Configuring for Serial-Type IQecg® Module

If using a serial-type IQecg®, select the serial port for the ECG module in the Configuration Settings screen. Click Serial Port to open the following dialog box:

 NOTE: The default serial communications port is COM 1.

Click Auto Detect to find the port that the IQecg® is connected to. The IQecg® module must be connected to an available serial port on the computer. Confirm that a fresh set of batteries is installed in the ECG module and click Auto Detect for ECG COM ports.

Configuring for USB-Type IQecg® Module

If using a USB-type IQecg® and it is already connected to the computer, the ECG COM Port setting will be disabled once it is detected.

IQecg® Operation Manual

Thin Client Channel Setting

The Thin Client Channel setting applies only when using IQmanager® in a thin client environment. This setting is ignored when the software is not running in a thin client environment. The drop-down list contains the following selections:

• COM port mapping (default)

• Microsoft RDP

• Citrix

Select COM port mapping if using IQmanager® in a thin client environment and are not using IQpath™. If using IQpath™, select Microsoft RDP or Citrix, depending on what the clients and servers are using. Refer to the document Setup Manual: Midmark Products over Thin Client using IQpath™ or COM port mapping for more information.

Database Settings

IQmanager® uses the local database by default. If using a network database, the default can be set either to the local or network by clicking Database Settings on the IQmanager Configuration screen.

Select a network database as the default by checking the Enable Network Database box then clicking Network. Refer to the IQmanager® Operation Manual for more details.

If using a Midmark IQholter® system, a different location can be selected to store the Holter ECG files.

List Management

The List Management configuration option customizes the lists used in IQmanager®, including:

• Medications,

• History Statements,

• ECG/Holter Indications,

• Race Categories,

• ECG Statements, and

• User Names (The names of doctors and technicians can be entered here.)

IQecg® Operation Manual

Modifying these lists saves time when using them in the appropriate testing screens.

1. To access List Management, open the Configuration setting and click List

Management.

2. Select either the local or network database and click Manage Lists. This will open

the List Management dialog box to add, edit and delete the lists that appear throughout the program.

General List Management Tab

Customize the Medications, History Statements, ECG/Holter Indications and Race Categories. Select the desired item from the pull-down list to modify. Click Add, Edit or

Delete.

IQecg® Operation Manual

• Add: Add an item to the list. A pop-up box will appear that allows you to enter

in the new information.

• Edit: Edit an existing item. Highlight the statement with the cursor, and then

click Edit.

• Delete: Delete an existing item. Highlight the statement with the cursor, and

then click Delete.

ECG Statements tab

Customize the ECG Statements list in order to quickly edit when interpreting an ECG. Add, Edit and Delete work the same way as in the General List Management tab. These statements will be available when editing the ECG interpretations online.

IQecg® Operation Manual

• Add: Add a statement to the list. A pop-up box will appear to enter the new

information.

• Edit: Edit an existing statement. Highlight the statement with the cursor, and

then click Edit.

• Delete: Delete an existing statement. Highlight the statement with the cursor,

and then click Delete.

 NOTE: Delete All will delete all the ECG statements.

• To repopulate statements into this screen, the user may either;

o Add new diagnostic statements, or o Choose from the two lists available through Load Default Statements.

The two ECG statement list options are IQmark Default List* or AAMI SCP-ECG.

IQecg® Operation Manual

*The IQmark Default List is the default list installed with IQmanager®.

IQecg® Operation Manual

User Names tab

Add, modify or delete the list of physicians and technicians that appears when a new test is started. Names can be assigned to one or both lists. Type in a user’s name and define the user as a physician, technician, or both.

1. Click Add and the following dialog box will appear:

2. Enter a User Name.

3. Check the box(es) indicating on which list(s) the name should appear and click OK.

The names will appear in the New Test and Review windows.

IQecg® Operation Manual

ECG Settings

Set the default settings to use for ECG tests by clicking ECG Settings from the IQmanager Configuration Settings dialog box.

The ECG Settings dialog box appears:

IQecg® Operation Manual

ECG Lead Group

When acquiring an ECG report, IQmanager® Version 8.6 and later offers two options:

• Standard 12-Lead ECG lead group, and

• Modified 12-Lead ECG lead group. (Refer to Section III-D Testing A New Patient/ Live

ECG for more information on these options.)

Default Interpretation And Acquisition Display Settings

The Lead Group V1, V2,V3 (V3R,V1,V2) specifies V1,V2,V3 if Standard 12

L is selected; it specifies

Item Settings Comments

Default setting is 25 mm/sec. Sweep Speed setting only applies to real time ECG

display. The ECG report only prints at 25mm/sec scale, except if a 2-Page Format is selected. See Printer Format Settings.

Sweep Speed

• 10 mm/sec

• 25 mm/sec

• 50 mm/sec

IQecg® Operation Manual

• 5 mm/mv

Gain

Filters

Rhythm Lead

The Rhythm Lead V3 (V3R) specifies lead V3 if Standard 12-Lead (V1,V2,V3,V4,V5,V6) is selected when a new ECG test is started; it specifies lead V3R if Modified 12-Lead (V3R,V1,V2,V5,V6,V7) is selected. V4 (V7) has a similar definition.

Lead Group

V3R,V1,V2 if Modified 12-L is selected. The Lead Group V4, V5,V6 (V5,V6,V7) has a similar definition

Display Format

Display Realtime ECG Tracings

• 10 mm/mv

• 20 mm/mv

• Muscle: On/Off

• AC: On/Off

• Drift: On/Off

Select any lead I,II,III, aVR, aVL, aVF, V1,V2,V3(V3R),V4(V7),V5,

• I, II, III

• aVR, aVL, aVF

• V1, V2, V3 (V3R,V1,V2)

• V4, V5, V6 (V5,V6,V7)

• 3x4 leads plus rhythm

• 4 leads

• 12 leads

On/Off

½ gain Standard gain (default setting) 2X gain

Default settings are MYO: Off, AC: On, Drift: On. See Note following this table.

Default setting is Lead II. This setting applies to both the 3x4 and 4-lead

display formats, and to the RR Variability analysis rhythm lead.

Default setting is I, II, III. This setting applies to the 4-lead display format.

Default setting is 3x4 plus rhythm lead.

Default setting is On (checked). If this setting is Off (cleared), the live ECG screen

will not display real time tracings while acquiring ECG data. Set it to Off only if the computer has problems displaying real-time ECG.

Default setting is On (checked). Controls how the ECG waveforms are drawn in

the real-time display screen. Selecting On

Waveform Smoothing

On/Off

produces smoother waveforms. In contrast, selecting Off (cleared) may produce waveforms that appear jagged.

 NOTE

: If using a slow PC or having delayed

ECG tracing, set to Off.

Default Interpretation And Acquisition Display Settings

Item Settings Comments

Default is Off (cleared). If On (checked), the ECG will not produce any

diagnostic statements and the interpretation

Disable Interpretation

Disable Quick Edit

Disable QTc Formula Warning

On/Off

portion of the report, ECG Review and Edit screen will be blank.

 NOTE: Modified 12-Lead ECG lead group does

not provide automatic interpretation statements.

Default is Off (cleared) If On (checked), the software defaults to free text

entry method for adding any diagnostic statements, instead of the Quick Edit feature of the Add a Statement dialog box. See Editing Diagnostic Statements.

Default is Off (cleared).

If On (checked), the software will not display a warning message that the QTc formula on the report will be changed, based on new QTc1 and QTc2 settings, when the report is edited and saved.

IQecg® Operation Manual

Hide Measurement Matrix

Display Mode

On/Off

• Legacy Mode

• Enhanced Mode

Default is Off (cleared).

If On (checked), the Details screen will display longer duration of ECG tracings without the Measurement Matrix.

Legacy Mode shows about 2 seconds of each lead in 3x4 lead format, plus ten seconds of a selected rhythm lead, and the background is white in live, review and print modes.

Enhanced Mode shows about 2.5 seconds of each lead in a 3x4 lead format, plus ten seconds of a selected rhythm lead in enhanced display quality; in live and review modes, the background is black and grid lines appear; in print mode, the background is white.

 NOTE

: Changes to the Display Mode setting

are reflected on the next new test.

IQecg® Operation Manual

Default Interpretation And Acquisition Display Settings

Item Settings Comments

QTc 1 default is Hodges (QTcH). QTc 2 default is None. These settings determine what QTc equation(s) to

include in the report.

Bazett:

QTcB = QT/√RR, where RR is in seconds;

Framingham:

QTcFh = QT + 0.154 (1000 – RR), where RR is in milliseconds;

Fridericia:

QTcFd=QT/∛RR, where RR is in seconds;

Hodges:

QTcH = QT + 1.75 (HR – 60);

Where RR is the R-R interval and HR is the averaged heart rate in beats per min. QTc is expressed in milliseconds.

 NOTE: Any changes to QTc 1 and QTc 2 settings

will apply to the ECG report if the report is edited.

Default is Standard 12-Lead.

Select one of the two choices to be the default resting ECG lead group.

 NOTE: This setting does not affect STAT ECG.

STAT ECG assumes standard 12-lead ECG placement.

 NOTE: Modified 12-Lead ECG lead group does

not generate automatic interpretations.

QTc 1 QTc 2

ECG Lead Group

• None

• Bazett (QTcB)

• Framingham (QTcFh)

• Fridericia (QTcFd)

• Hodges (QTcH)

•

Standard 12-Lead (V1,V2,V3,V4,V5,V6)

•

Modified 12-Lead (V3R,V1,V2,V5,V6,V7)

 NOTE: For all pacemaker patients, it is strongly recommended that the ECG be performed

with all filters turned off, particularly the MYO filter.

Any artifacts in the ECG should be corrected at the source, (i.e., making sure the electrode sites are clean of lotion or body hair, the electrodes are fresh and sticky and are adhering properly on the skin).

Patient should be supine, relax and not talking. Refer to ECG Signal Quality Problems in the Troubleshooting Guide for more details.

IQecg® Operation Manual

Printer Settings

Click the Printer Format Settings tab of the ECG Settings dialog box to select the default ECG report format.

The Rhythm Lead V3 (V3R) specifies Lead V3 if Standard 12-Lead (V1,V2,V3,V4,V5,V6) is selected when a new ECG test is started; it specifies Lead V3R if Modified 12-Lead (V3R,V1,V2,V5,V6,V7) is selected. V4 (V7) has a similar definition.

The Rhythm Lead Group V1, V2,V3 (V3R,V1,V2) specifies V1,V2,V3 if Standard 12-Lead is selected; it specifies V3R,V1,V2 if Modified 12-Lead is selected. The Rhythm Lead Group V4, V5,V6 (V5,V6,V7) has a similar definition.

IQecg® Operation Manual

elect the print scale of 25 mm/sec

The Rhythm Lead V3 (V3R) specifies Lead V3 if

Standard 12

Lead

(V1,V2,V3,V4,V5,V6) is selected

The Rhythm Lead Group V1, V2,V3 (V3R,V1,V2) specifies V1,V2,V3 if

Standard 12

Lead

is selected;

is printed in the selected color

ECG Report Printer Format Settings

Item Settings Comments

• 6 x 2 format

• 12-lead with 3-lead

Printer Format Settings

Rhythm Lead

when a new ECG test is started; it specifies Lead V3R if Modified 12-Lead (V3R,V1,V2,V5,V6,V7) is selected. V4 (V7) has a similar definition.

Rhythm Lead Group

it specifies V3R,V1,V2 if Modified 12-Lead is selected. The Rhythm Lead Group V4, V5,V6 (V5,V6,V7) has a similar definition.

Print After Analysis

Print Measurements

Grid

rhythm format (3x4+3)

• 12-lead format (12x1)

• 12-lead plus single rhythm

format (3x4+1)

• 2-Page Format

Select any lead I, II, III, aVR, aVL, aVF,

V1,V2,V3(V3R),V4(V7),V5,V6

• I, II, III

• aVR, aVL, aVF

• V1, V2, V3 (V3R,V1,V2)

• V4, V5, V6 (V5,V6,V7)

On/Off

On/Off Black, Red or Green

Default setting is 12-lead plus single rhythm format.

2-Page Format prints leads I, II, III, aVR, aVL, and aVF on the first page and V1-V6 (V3R-V7) on the second page. S or 50 mm/sec when printing in 2-page format. Other formats will always print at 25mm/sec scale.

Default setting is II. Applies to 12-lead plus single rhythm format

(3x4+1) above.

Default setting is I, II, III. Applies to 12-lead with 3-lead rhythm format

above.

Default setting is Off (cleared). When On, the resting ECG report is

automatically printed following analysis.

NOTE: For speed, set to Off and print

manually.

Default setting is Off (cleared). When On, the detailed measurement matrix

report is printed automatically with the ECG report.

Default setting is On (checked). When on, the grid

if a color printer is used.

IQecg® Operation Manual

RR Variability Setting

Click RR Variability Settings tab of the ECG Settings dialog box to preset the default test duration and report format. Rhythm Leads provides choices for the three rhythm leads from all available leads.

Item Settings Comments

RR Duration

RR Print Speed

Print After Analysis

RR Variability Settings

• 30 sec

• 60 sec

• 90 sec

• 120 sec

• 150 sec

• 180 sec

• 210 sec

• 240 sec

• 360 sec

1) 5 mm/sec

2) 10 mm/sec

3) 25 mm/sec

On/Off

Default setting is 90 sec.

This setting defaults the length of the rhythm strip acquired through Start RR test. The rhythm strip is defined in the ECG Settings.

Default setting is 25 mm/sec. This setting defines the print scale of the ECG tracings

for RR test.

Default setting is Off (cleared). When set to On (checked), the RR test report is printed

automatically following successful completion of RR test analysis.

NOTE: For speed, set to Off and print manually.

IQecg® Operation Manual

RR Variability Settings

Item Settings Comments

Default setting is Off (cleared).

Print Graphics Report

Rhythm Lead

On/Off

Select any three leads

I, II, III, aVR, aVL, aVF, V1, V2, V3(V3R), V4(V7), V5, V6

ECG Configuration Setting

Click the Configuration tab of the ECG Settings dialog box to access the ECG Configuration settings.

When set to On (checked), the graphic report, which includes the RR Trend and RR Histogram, is printed automatically with the RR rhythm strip report.

Default settings are II, V2 and V5.

Most of the settings on this screen are controlled by the IQmanager Configuration Settings and therefore cannot be changed, except for the line frequency and COM port auto detection for the IQecg®. Changes to these settings can be made from either screen.

Click OK on the ECG Settings dialog box to save any changes made. The system will return to the IQmanager Configuration Settings dialog box.

Once the configuration settings are set appropriately, click OK on the IQmanager Configuration Settings dialog box to store the settings. These settings will become effective the next time IQmanager® is started.

Click Cancel if configuration changes are not to be saved.

IQecg® Operation Manual

Click Default to restore the IQmanager® configuration settings (except Institution Name, Address and List Management) to their default values.

III. Operation

WARNING

The IQecg® module has been designed and tested to meet IEC 60601-2-25 and AAMI EC11

defibrillation protection standards. In the event of defibrillation, follow the instructions on

your defibrillator and adhere to all warnings and cautions.

A. Introductory Notes

This manual describes how to use the various IQecg® features and the operational sequence most users will follow. This does not mean that a user is restricted to following this particular sequence. There are certain sequences that must always be followed, such as entering a patient’s medical data prior to acquiring an ECG. However, this program is designed to be both user-friendly and flexible.

Many of the features are interconnected and can be accessed from more than one screen. The menu bar, buttons or tabs on each screen lead the user to a different screen or feature. To enter any of these screens, click once on the appropriate selection.

For user convenience, we have included a condensed guide to the operation of the IQecg® with new patients in Appendix A, Operations at a Glance.

B. Patient Preparation

Careful preparation of the patient’s electrode sites is important for obtaining an interferencefree ECG and accurate result. 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. Instructions for Performing ECG Acquisition

Patient Position

The patient should be placed comfortably in a supine position. Any variation should be noted on the ECG report.

Prepare Patient Skin

Shave hair from electrode sites if necessary.

Abrade these areas with fine sandpaper or an abrasive pad.

Rub skin with alcohol wipes. Allow th

Check to ensure the electrodes are fresh and sticky. The technician’s fingers must be clean and

free of lotion when handling electrodes.

Adhere electrodes to the patient.

Attach the ECG clips from the patient cable to the ele

Right Arm electrode is placed on a distal portion

the right lateral side of the upper arm below the shoulder.

Left Arm electrode is placed on a distal portion of

left lateral side of the upper arm below the shoulder.

Right Leg electrode is placed on the i

midway between knee and ankle.

Left Leg electrode is placed on the

midway between knee and ankle.

Placement

right margin of the sternum.

left margin of the sternum.

Midway between V2 and V4 (on top of the 5

left midclavicular line.

orizontal level of V4, at the anterior

orizontal level of V4, at the midaxillary line.

standard 12

automated ECG analysis algorithm assumes standard 12

Any deviation from the standard 12

accuracy of the automated interpretation.

(Reference diagrams below.)

ctrodes according to color coding.

Standard 12

Lead ECG Placement when performing a STAT ECG.

lead ECG placement.

lead ECG placements may affect the

IQecg

Operation Manual

•

Electrodes

•

Limb Lead Placement

RA (White) –

LA (Black) –

RL (Green) –

e skin to air dry.

the

nside calf,

LL (Red) –

Standard 12-Lead

V1 (Red) – 4th intercostal,

V2 (Yellow) – 4th intercostal,

V3 (Green) –

V4 (Blue) – 5th intercostal,

V5 (Orange) – H

V6 (Purple) – H

 CAUTION: Follow

inside calf,

(Precordial)

rib).

axillary line.

-Lead ECG Hookup

The

Modified 12-Lead Placement (Precordial & Posterior)

Precordial

Posterior

V3R (Green) – corresponds to V3 on the Right side V1 (Red) – 4th intercostal, right margin of the sternum. V2 (Yellow) – 4th intercostal, left margin of the sternum.

V5 (Orange) – Horizontal level of V4, at the anterior axillary line.

V6 (Purple) – Horizontal level of V4, at the midaxillary line.

V7 (Blue) – Horizontal level of V4, at the posterior axillary line

Modified 12-Lead ECG Hookup

IQecg® Operation Manual

NOTE: The live ECG acquisition screen will show the signal tracings after all limb leads have

been connected. When the right-leg (RL) lead becomes detached, the system behaves as if all electrodes were disconnected.

 NOTE: Lead placement does affect the ECG waveform. When the limb leads are placed on

the torso, waveform changes might be seen in the QRS amplitude, axis shift occurs, Q waves can be seen, and T waves might appear flipped or flattened. These changes are clinically significant in that they are associated with cardiac ischemia. If a nonstandard lead placement is used, note the variation in the ECG comment field.

 CAUTION: Do not use Modified 12-Lead ECG Placement when performing a STAT ECG. The

automated ECG analysis algorithm assumes standard 12-lead ECG placement. Any deviation from the standard 12-lead ECG placements may affect the accuracy of the automated interpretation.

with IQmanager

The software application for operating the

computer desktop as a shortcut icon. Double

For a detailed description of diagnostic functions available through

IQmanager

the

IQecg

and is located on the

IQmanager

Operation Manual

C. Operation of IQecg®

Starting the Program

 NOTE:

refer to the

Opening Screen

When starting IQmanager®,

IQecg® is called IQmanager®

-click on this icon to start

Midmark

IQmanager®

® Operation Manual.

opening screen appears:

®.

IQmanager®,

Opening Screen Buttons

egister a

for a description of the patient details required for specific tests.

iew a list of patients previously entered into the database

electing a patient from the list

data

previous tests.

Acquire an ECG before entering patient demo

selecting a patient

Enables users to select which database to use and configure

program to meet their needs

for

nline assistance regarding the use, operation and

troubleshooting

Calibrate the Midmark

the program and returns

Connect to the Midmark website. These links only work if

onnected to the Internet.

automated ECG analysis algorithm assumes standard 12

Any deviation from the standard 12

accuracy of the automated interpretation.

at a stat ECG is required, hook up the

STAT ECG

having to enter the patient information.

New Patient

STAT ECG

Help

Spirometer

Operation Manual

, edit, add and

patient’s records and view data from

graphics or

, Configuring

o the Windows desktop.

lead ECG placement when performing a STAT ECG.

lead ECG placement.

lead ECG placements may affect the

to immediately access the live ECG test screen without

without saving

IQecg®

Patient List

Settings

V s delete

IQecg®

New Patient. Refer to the product’s

;

allows access to

from that

the

. (See Section II-E

for more information.)

of IQmanager® and other products.

Calibration

Exit

STAT ECG

 WARNING: Follow standard 12

In the event th up to the IQecg® and click

IQspiro® device.

patient using a STANDARD

A live ECG report can be printed

The

-lead hook-

the

IQecg® Operation Manual

patient test or click Analyze to have the computer analyze and save the report. The system will prompt the user to enter the patient information when exiting the Report Review screen.

 NOTE: The green LED on the ECG module will light when the module is on.

D. Testing a New Patient

To create a new patient file, click the New Patient icon on the Opening screen. This opens the Patient Data Entry screen, to enter the patient’s specific data.

NOTE: If changes are made to any of the Vital Signs tabs after clicking New Patient from

the Opening screen, a patient record must be created in order to exit the screen.

 NOTE: A patient name or ID must be entered to start a new test. It is highly recommended

to enter all information available, including an ID.

Click in any text box or press the Tab key to enter information. This information may not be essential for the acquisition of an ECG, however, it is important to complete each of the fields as accurately as possible, particularly Date of Birth, Sex, and Medications, which are used by the Midmark 12-Lead Resting ECG Analysis Program to produce diagnostic statements. The blood pressure values entered will be displayed and printed on the ECG report.

The Midmark analysis program is capable of interpreting ECG from infant to adult age by using age-dependent criteria. It automatically calculates the age of the patient based on the date of birth entered on the Patient Data screen, and the current date of the computer. Please make sure that the date and time on your computer is current.

Operation

prepared, calm and

on the menu bar o

. S

Enter the name of the technician conducting

Enter the diagnostic reason for performing the ECG in the

using a customized list configured through

Click on the drop down arrow for the appropriate field and click

ECG Lead Group drop down menu provides two options:

have the same limb leads: I, II, III, aVR, aVL, aV

has a conventional and standard chest lead

uses V3 as V3R and V4 as V7.

Lead ECG lead group

Lead

(V3R,V1,V2,V5,V6,V7) for pediatric patients

Modified 12

the V7 location

IQecg®

Operation Manual

Patient Data

ECG data

icon in the left

physician.

This information is

practice, select

does not generate automatic interpretations.

(V1,V2,V3,V4,V5,V6) for adult patients and

the V3R location

Refer to the IQmanager® screen.

Live ECG

When the patient is properly acquisition by clicking New Test

The New Test dialog box appears hand portion of the dialog box.

Manual for additional information on the

is comfortable, initiate the

n the Patient Data screen.

elect the test type to run. Click the ECG

optional. If these entries from the lists. on the desired selection.

The

• Standard 12-Lead, and

• Modified 12-Lead

Both options

• Standard 12-Lead

• Modified 12-Lead

 NOTE

Modified 12-

The user can choose Standard 1212-Lead

If performing an ECG using the right chest and V4 lead on

the test and the requesting

Indication field.

List Management for the

placement

if needed.

-Lead option, place the V3 lead on

on the back.

Modified

IQecg® Operation Manual

Click OK to open the live ECG screen. The ECG module will turn on automatically and the green LED on the module will light.

 NOTE: The laptop computer’s AC adapter may introduce electrical interference. For best

ECG result, do not use the AC adapter while running a live ECG.

Figure 3-1 Standard 12-Lead

Figure 3-2 Modified 12-Lead

The live ECG screen displays the results of the 12-channel ECG in the three-by-four (3x4) leads display format. This format can be changed by using the Settings function.

(V3R,V1,V2,V5,V6,V7) is selected

he live ECG screen displays a message: “Place V3 lead on V3R, V

top center for about 10 seconds

he chest leads on the live ECG screen are arranged in the order of V3R, V1, V2, V5, V6,

automated ECG analysis alg

Any deviation from the standard 12

accuracy of the automated interpretation.

Lead ECG lead group

lity’s name, date, time and the patient’s heart rate appear at the top of the screen

names of the three rhythm leads for

Variability” in the bottom right corner.

The sweep speed, gain and filter settings are b

Changes

the test is active.

by clicking

resets the ECG module and stabilizes the ECG baselines.

r of the screen are the status indicators for

An empty status indicator means that

Once a report is created, the indicator next to the test type appears

This indicator is not affected by tests that were previously stored or reviewed in the

The menu bar at the bottom of this screen provides different options

options change according to the settings and the process

button on the live ECG screen provides a way to change the ECG lead group

IQecg®

Operation Manual

on V7” at the

message disappears the

lead ECG placement when performing a STAT ECG. The

lead ECG placement.

lead ECG placements may affect the

does not generate automatic interpretations.

the right of “RR

ECG tracings are in the center of the screen moving

lick the appropriate

are temp

and set them as the default

and

not acquired the specific report

The

If Modified 12-Lead

• T

facility’s name is displayed

• T

V7.

 CAUTION: Follow standard 12

 NOTE

Modified 12-

The faci

from left to right.

button to modify its setting. and only apply for as long as settings for all new ECG tests

Clicking on INST

(see Figure 3-2). Once the

orithm assumes standard 12-

the RR Variability test are displayed to

The

elow the moving tracings. C

to these settings made from this screen

Make changes

Settings.

4 lead

. The

orary

In the lower-right corne Variability.

the user has

ECG Report

since entering the screen. solid. database.

available.

established.

The blue Settings after the new test is started.

available

Standard 12

down menu at the bottom of the

page. If the ECG lead group is changed and

Prints the last 10 seconds of ECG data being collected.

measurements or diagnostic statements.

function prints out the last 10 seconds of

lick

multiple

up printing,

Performs resting analysis

, which

Print After Analysis

Freezes the display and copies the last 10 seconds

If there are less than 10 seconds of ECG data collected, the freeze function

is delayed until the 10

unfreeze the display and clear the memory buffer.

Analyze

group from the ECG Lead Group

Default Interpretation And Acquisition Display Settings

button is clicked, the lead group change takes

This report contains no

s not actively being collected

more than once before the report is printed produces

is disabled until the report is printed.

and stores this analysis as

screen or by

of ECG data into a memory

Click this button a second time to

When the di

, this

splay is frozen, click

The user can select drop-

effect immediately.

-Lead or Modified 12-Lead

IQecg

Operation Manual

Button Icon

Analyze

Freeze

 NOTE: C

an ECG Report selecting

buffer.

Print or

Patient Data Screen Buttons

Function(s)

ing Print

printouts. Exit

click Freeze before clicking Print.

on the last 10 seconds of data

can be printed from the Report Review

in the Printer Format Settings.

-second buffer is filled.

If data i

data in memory.

To speed

Patient Data

Button Icon

This option is only available if the

Click on this button to display the ECG tracing acquired in the last 10

Tracings are displayed in static for

button to analyze and save the ECG displayed.

This option is only available if the

Click on this button to start new acquisition of ECG data.

will display on

ECG data for

seconds of ECG data may be collected in 30

Stop data collection by clicking

performed if less than 30 seconds of data

program will automatically analyze the data and store the report.

Variability reports by clicking

RR Variability Settings

tab dialog box for changing the

, which are similar to those descri

Help

Patient Data

ndicates at least an ECG or

the most recent report in the

Verify clean waveform before pressing

and stores a test report when

Analyze

If the patient’s right and left arm leads are swapped, the software will then

display the warning message as shown below.

Operation Manual

setting

Click on the

setting is

A message

A preset duration between 30 and 360

No RR Variability analysis is

Otherwise, the

Print RR

Default Interpretation And

Configuring the

Click this button

ECG acquisition.

Variability test has been performed.

is clicked on

instructs the program to acquire, analyze and store a

Screen Buttons

Function(s)

IQecg®

Display

Acquire

Start RR

Setting

disabled. seconds. Analyze

disabled.

Acquiring ECG

Collects

in the Opens a four-

Acquisition Display Configuration

IQecg®.

Display Real-time ECG Tracing

m and are not stored.

Display Real-time ECG Tracing

the screen.

RR Variability analysis.

-second increments.

Start RR again.

has been collected.

Exit and selecting Print, or select

to print reports automatically.

ettings, Printer Format settings, RR Variability

bed in Section II-E,

After Analysis

ettings and

Displays the online

Help

ndicates an ECG or

to return to the

Exit

Review

 NOTE:

The IQecg® collects Live ECG screen. Selecting resting ECG Report.

screen.

Variability Report has not been collected.

screen and terminate

Review Reports screen.

Analyze or Start RR

button

Analyze or Start RR

Click to display

from the

IQecg® Operation Manual

Select Yes to save the report. Select No to discard this test, correct the arm leads and re-test the patient.

Selecting Start RR instructs the program to begin acquisition for an RR Variability Report. When a minimum of 30 seconds of ECG data has been acquired, the program proceeds to analyze the data and will store an RR Variability report in the IQmanager® database. There is no limit to the number of reports collected for a given patient using the Analyze and Start RR functions.

Resting ECG and RR Variability reports are stored in the designated database for future reference, whether locally on the hard drive or remotely in a central database. IQmanager® provides many record management features that make it easy to retrieve and review this information later.

IQecg® Operation Manual

Diagnostic

Gain

Sign

Measurements

E. Reviewing Patient Reports

After a report has been collected through Analyze or Start RR, click Review on the Live ECG screen to access the Report Review screen. Data from the latest report collected will be displayed with the format reflecting the method of collection (i.e., Analyze or Start RR).

ECG Report Review

Statements

Figure 3-3 Standard 12-Lead

Figure 3-4 Modified 12-Lead

Reports collected using the Analyze function will be displayed on the Report Review screen with ECG data traces from each of the patient leads. Click on any part of the ECG tracings to

IQecg® Operation Manual

zoom in to view in 2X magnification. Click again on the ECG tracings to return to the normal view. In normal and magnified views, move or pan the ECG tracings to view the other leads by holding down the Shift key and dragging with the mouse.

The Sign checkbox is used for signing off the report. If the Sign checkbox is unchecked, it indicates the report has not been signed by a physician and can still be edited. If the Reviewed By box is filled in with a physician’s name and the Sign checkbox is checked and saved when the review screen is exited, the report becomes read-only. If the user tries to check the Sign checkbox without first typing the reviewer’s name in the Reviewed By box, a warning message will pop up as follows:

If Standard 12-Lead (V1,V2,V3,V4,V5,V6) is selected, the chest leads are arranged in the order of V1,V2,V3,V4,V5,V6 (see Figure 3-3).

If Modified 12-Lead (V3R,V1,V2,V5,V6,V7) is selected, the chest leads are arranged in the order of V3R,V1,V2,V5,V6,V7 (see Figure 3-4).

 NOTE

Modified 12-Lead ECG lead group does not generate automatic interpretations.

If the ECG amplitude is too tall or too short for viewing, click Gain 1X to increase the amplitude gain to 2X (20mm/mv) or decrease to 1/2X (5mm/mv).

The analysis results are displayed in the two text boxes on the upper-right portion of the Report Review screen. The attending physician must review and evaluate the diagnostic interpretation and the measurements.

The computerized interpretation is not a substitute for physician interpretation.

All ECG must be examined with respect to the patient’s overall clinical condition.

The measurement box may display up to two QTc (i.e. QT intervals corrected for heart rate) based on QTc 1 and QTc 2 settings. See Section II-D, Configuring IQecg®/ECG Settings.

When an ECG report is opened for review, the QTc 1 and QTc 2 data saved last will be displayed. If changes are made to the report, the QTc 1 and QTc 2 information will be updated based on the current selections in the QTc 1 and QTc 2 settings.

IQecg® Operation Manual

When editing a report is first started, a “New QTc Formula Update” warning message will appear to notify the user of the changes in QTc data. The change must be accepted in order to edit the report.

To skip future warning messages regarding QTc formula updates, check the “Do not show any New QTc Formula Update message again”.

 NOTE: If IQmanager® has been updated from a version prior to 8.5, see section Appendix B

Upgrading an IQmanager® software version 8.5 and earlier to understand the

impact to older ECG reports.

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

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.

To edit the data in the measurements box, other than QTc, double-click on its title, e.g. Rate, for heart rate.

 NOTE: If Rate or QT value is edited, the QTc 1 and QTc 2 data will automatically recalculate

using the new value and the specific QTc formula. For additional information see

Section II-D, Configuring IQecg®/ECG Settings.

Editing Diagnostic Statements

Some patients have specific physiological profiles that can affect the IQecg® interpretation of their test results. If the physician believes there are any discrepancies in the diagnostic statements, the statements can and should be edited.

To modify diagnostic statements, either edit the statements directly in the text box, or click Add (enter new diagnostic statements) or Clear/Add (clear all statements and add new ones from a pre-established list); clicking either will open the Add a Statement dialog box:

IQecg® Operation Manual

In the top box, begin typing the abbreviation of a statement and the statement itself (e.g., RBBB - Right bundle branch block) or select a statement from the list by clicking the down arrow; the statement appears in the box below, where it can be edited.

 NOTE: If the statement list is empty, no default ECG statement list is selected in List

Management. Refer to Section II-D Configuring IQecg®/List Management for how to load the default statements through List Management.

 NOTE: If Disable Quick Edit is checked on the Default Interpretation and Acquisition Display

Settings dialog box, the cursor is placed in the lower edit box by default for free text

entry.

Diagnostic statements can also be edited through the Details screen.

 NOTE: If Disable Interpretation is checked on the Default Interpretation and Acquisition

Display Settings dialog box, no interpretive statement appears in the ECG Report Review screen and the top center box is blank. The top right box, however, still

displays the measurements.

 NOTE: If a stat ECG was run, STAT ECG is displayed in the ECG window above Lead I.

IQecg® Operation Manual

Lead

ECG Report (Details) Review

Click Details to display a detailed measurement screen like the one shown below:

Figure 3-5 Standard 12-

Figure 3-6 Modified 12-Lead

If Standard 12-Lead (V1,V2,V3,V4,V5,V6) is selected, the chest leads and measurement columns are arranged in the order of V1,V2,V3,V4,V5,V6 (see Figure 3-5).

If Modified 12-Lead (V3R,V1,V2,V5,V6,V7) is selected when acquiring a new ECG report, the chest leads of ECG tracings and measurement columns are arranged in the order of V3R,V1,V2,V5,V6,V7 (see Figure 3-6).

IQecg® Operation Manual

If Hide Measurement Matrix is checked on the Default Interpretation and Acquisition Display Settings dialog box, the Details screen will display longer ECG strips.

Standard 12-Lead (V1,V2,V3,V4,V5,V6)

Modified 12-Lead (V3R,V1,V2,V5,V6,V7)

Click View 2X in the ECG Report Review (Details) screen to magnify the 12-lead ECG tracings on the left to 2x zoom. Click the same button again and ECG tracings are displayed with 4x magnification.

Click Calipers to select between Simple Calipers or P-QRS-T Calipers. These electronic calipers allow you to measure the amplitude (mv) and duration (ms) of any part of the ECG waveform, making it easy to over read ECG tests online without printing them.

IQecg® Operation Manual

Simple Calipers

The Simple Calipers are shown on the following screen shot. To move the pair of Simple Calipers together with a fixed interval, place the mouse on one of the calipers, hold down the Ctrl (Control) key and drag to a desired location.

Selecting the P-QRS-T Calipers will prompt the reviewer to select a specific beat from the 10 seconds of ECG. Click on the QRS complex of the desire beat and a screen similar to the following will display.

 NOTE: These measurements do not represent any editing made to the General

Measurements or interpretation.

Click and drag any of the calipers will update the P-QRS-T Calipers box accordingly.

IQecg® Operation Manual

 NOTE: The QTc 1 and QTc 2 information on the P-QRS-T Calipers box reflects the current

ECG settings, which may be different from the saved data.

 NOTE: Any changes made in this screen, which reference an individual beat, will NOT be

saved.

Edit Comments displays a text box for entering and editing report comments that are printed at the top of the ECG report.

General Meas. displays a dialog box showing the general measurements, which are also displayed on the previous ECG Review screen and on the ECG report, if printed.

See Section III-E, Reviewing Patient Reports for information on how to change these values.

Axis Meas. displays a dialog box showing the axes (frontal, horizontal and sagittal) for the P, QRS and T waves.

Show Medians switches the ECG display between the median beats (representative beats) or the 10-second ECG tracings. While displaying the Show Medians beats, clicking Show Ref. Points displays the reference points for onsets and offsets of the P-QRS-T component waves of the median (representative) beats.

 NOTE: These reference points do not represent any editing made to the General

Measurements or interpretation.

IQecg® Operation Manual

Make adjustments, when necessary, using the P-QRS-T Calipers to obtain new measurement values while on the Show Medians beats screen as follows.

 NOTE: The reference points for P-QRS-T Calipers do not represent any editing made to the

General Measurements or interpretation.

1. Click View 2X button twice to magnify median beats

2. Click Calipers button and select P-QRS-T Calipers

3. To move the P Onset point, click on the P Onset radio button, then simply move the

mouse to a desire location and click.

4. Repeat with the rest of the measurement points

IQecg® Operation Manual

 NOTE: When moving the calipers, the relevant values in the P-QRS-T Calipers box will

change. The QTc data will automatically update based on the specific equation(s), heart rate, or RR, and QT as described in Section III-E, Reviewing Patient

Reports/ECG Report Review.

Clicking Yes above will update the PR, QRSd, QT, QTc 1 and QTc 2 measurements in the General Measurements box and ECG Report Review screen.

View and edit the diagnostic statements from the ECG Report Review (Details) screen by clicking Edit Diagnosis. The Edit Diagnostic Statements dialog box appears; see Section III-E,

Reviewing Patient Reports/Editing Diagnostic Statements for details.

IQecg® Operation Manual

Figure 3

-8

Serial Comparison

This feature provides access to compare up to four ECGs from the same patient. If the patient has more than one ECG report, click Serial Comparison on the Report Review screen and the Select ECG Reports dialog box appears. Choose the desired test selections and click OK. Modified 12-L (V3R,V1,V2,V5,V6,V7) ECG reports are marked with “(m)” on the right.

Only ECG reports with the same lead group can be compared. Figure 3-7 shows that four Modified 12-Lead ECG reports are selected and the serial comparison is enabled.

Figure 3-7

IQecg® Operation Manual

If the selected ECG reports have both Standard 12-L (V1,V2,V3,V4,V5,V6) and Modified 12-L (V3R,V1,V2,V5,V6,V7), the OK button is disabled (see Figure 3-8).

The following sample Serial Comparison screen shows four ECG reports simultaneously.

• Summaries of each ECG report are displayed at the top-right section.

• Each report is given a report number, shown to the left of the date.

• ECG tracings are color-coded to identify different reports, as indicated at the lower left

corner.

• Clearing a report check box turns off the median beats for that report, displayed on the

left side of the screen.

• Median beats are superimposed so that subtle differences can be viewed easily.

• Rhythm strips from each report are displayed in the lower right section together with

the report number and lead label.

• Different rhythm leads can be viewed by clicking the down arrow button next to the

Rhythm Lead indicator.

If Standard 12-Lead (V1,V2,V3,V4,V5,V6) is selected, the chest leads are arranged in the order of V1,V2,V3,V4,V5,V6 (see Figure 3-9).

If Modified 12-Lead (V3R,V1,V2,V5,V6,V7) is selected when acquiring a new ECG report, the chest leads of ECG tracings on the left of the screen are arranged in the order of V3R,V1,V2,V5,V6,V7 (see Figure 3-10).

Figure 3-9 Standard 12-Lead

IQecg® Operation Manual

Figure 3

-11 RR Variability Report Created with IQmanager

® Version 8.5 or Earlier

Figure 3-10 Modified 12-Lead

Click inside the median beat or the rhythm strip area to zoom in on the ECG tracings. Click again and ECG views return to the previous scale.

RR Variability Report Review

If a report was collected using the Start RR function and IQmanager® Software Version 8.5 or earlier, the ECG data is displayed on the Report Review as shown below (see Figure 3-11).

IQecg® Operation Manual

If a report was collected using the Start RR function and IQmanager® Software Version 8.6 or later, the ECG data is displayed on the Report Review screen as shown below (see Figure 3-12).

Figure 3-12 RR Variability Report Created with IQmanager® Version 8.6 or Later

The diagnostic results for the RR Variability analysis are displayed in text boxes on the upperright portion of the screen and cannot be edited.

• There are three rhythm leads which are selectable from RR Variability Settings.

• View the patient’s ECG tracing from the entire data collection period (30-360 seconds)

by clicking the <<< | >>> arrows above the traces.

• Each click on the <<< | >>> arrows shifts the ECG tracings left or right by 10 seconds.

• Click on the ECG tracings view to let the view get the focus.

• Press Left or Right button on the keyboard to move the ECG tracings left or right by 1

second.

• Click Gain 1X if the amplitude of the ECG is too tall or too short; clicking the same

button circulates through 2X (20mm/mv), 1/2X (5mm/mv) and 1X (10mm/mv) amplitudes.

RR Variability reports created with IQmanager® Software Version 8.5 or earlier have only one rhythm lead (see Figure 3-11). Each click on the <<< | >>> arrows shifts the ECG tracings left or right by 30 seconds.

The data collected can also be reviewed during the RR Variability analysis in RR Trend and RR Histogram formats by clicking the Show Graphs button.

IQecg® Operation Manual

On both the resting ECG and RR Variability Report Review screens, there are fields labeled Technician and Reviewed By. Ensure that the name of the technician doing the ECG is entered

in the Technician field, and that the name of the doctor performing the ECG review and confirmation in entered in the Reviewed By field. These names are important as they serve to document the ECG collection process and will assist people reviewing these reports in the future.

Click the Print button to print the report displayed on the screen.

When finished reviewing the patient’s reports, exit the Report Review screen by clicking the appropriate button on the bottom of the screen. If the diagnostic statements have been edited, or filled in blank fields, the system will prompt to save the changes prior to exiting the screen. The system will proceed to the next appropriate screen regardless of whether changes have been saved or not.

IQecg® Operation Manual

IV. Accessories for IQecg®

The following table shows the accessories approved by Midmark for use with the IQecg®.

 WARNING -- Use only approved accessories with the IQecg®. Substitution of a component different from that supplied might result in measurement error.

Item Part Number

Universal ECG Clips (3mmm & 4mm) 10/pack 3-047-0001 Clear ECG Clips (3 mm, 4mm, & Snap) 10/pack 3-047-0005 Patient Cable, Standard, IQecg® 3-100-0199 Disposable EZ-Trode ECG Electrodes (box of 500) 2-100-0205 Disposable EZ-Trode ECG Electrodes (case – 10 boxes) 2-100-0206

IQecg® Operation Manual

V. Appendices

A. Appendix A - Operations at a Glance – Standard 12-lead ECG

A condensed guide to using the IQecg® to acquire a standard 12-lead ECG.

1) Start IQmanager®.

Select search by patient’s last name or ID.

Complete the fields on the number to perform a test. Enter the date of birth and sex of the patient. Enter the patient’s vital signs. If the patient has a cardiac history, or is taking prescription medications, make sure to enter them on the appropriate tabs.

When the Refer to the lead hookup or refer to

New Patient

from the opening screen. For returning patient, select

Patient Data

screen is complete, prepare the patient for the resting ECG test.

Quick Reference User’s Guide

Section III – B Patient Preparation

Patient List

screen as accurately as possible. Enter a name or ID

included with the IQecg® kit, for a standard 12-

of this operation manual.

and

5) The green LED on the module will light when the ECG module is on.

Select

7) The following window will appear:

New Test

a. Make sure ECG is selected for “Test Type” b. Select or enter the Technician, Requesting Physician, and Indication information c. Select “Standard 12-lead” from the ECG Lead Group drop-down menu

on the menu bar, select the

ECG

test type and enter relevant information.

IQecg® Operation Manual

Click OK when the patient is prepared and comfortable.

Adjust the sweep speed and gain as necessary. If artifacts or noise occur in the ECG signal, please refer to ECG signal quality problems in the Troubleshooting Guide for corrective actions. Do NOT turn the MYO filter on for pacemaker patients.

10)

Wait for the ECG tracings to pass the screen twice (about 20 seconds) to verify that the signal quality is good and the baselines are stable.

11)

To acquire a test report, click either

•

Analyze

•

Start RR

prepare a RR Variability report.

12)

Reports are automatically saved and can be viewed upon exiting the ECG screen by the

Review

13)

Reports on the Report Review screen are in chronological order for the patient being tested, and are displayed on the ECG or RR Variability tabs.

button.

instructs the program to acquire, analyze and store a resting ECG test.

instructs the program to acquire a preset duration of the rhythm strip and

Analyze

Start RR

on the menu bar.

14)

Review reports from other patients by clicking

Patient List

IQecg® Operation Manual

B. Appendix B - Operations at a Glance – Modified 12-lead ECG

A condensed guide to using the IQecg® to acquire a modified 12-lead ECG .

 NOTE

1) Perform and acquire a standard 12-lead ECG test. (Refer to Appendix A for information on

2) While in the Report Review screen, prepare the patient for the modified 12-lead resting ECG

The modified 12-lead ECG provides the clinician the tool to acquire V3R and V7 using the IQecg® device and its 10-lead patient cable in a way that supplements the standard 12-lead ECG. We recommend performing a standard 12-lead ECG on the patient prior to performing a modified 12-lead ECG.

performing a standard 12-lead ECG test.)

test as follows:

Prepare V3R and V7 electrode sites according to best practice.

Apply new electrodes on V3R and V7 sites.

Remove V3 lead and attach to V3R electrode.

Remove V4 lead and attach to V7 electrode.

Refer to information.

3) Select

4) The following window will appear:

Section III – B Patient Preparation

New Test

• Make sure ECG is selected for “Test Type”

• Select or enter the Technician, Requesting Physician, and Indication information

• Select “Modified 12-lead” from the ECG Lead Group drop-down menu

on the menu bar.

of this operation manual for additional

 NOTE

Modified 12-Lead ECG lead group does not generate automatic interpretations.

5) Click OK when the patient is prepared and comfortable.

IQecg® Operation Manual

6) Click on the Settings button at the bottom of the screen to adjust the sweep speed and gain as

necessary.

• If artifacts or noise occur in the ECG signal, please refer to ECG signal quality problems

in the Troubleshooting Guide for corrective actions. Do NOT turn the MYO filter on for pacemaker patients.

7) Wait for the ECG tracings to pass the screen twice (about 20 seconds) to verify that the signal

quality is good and the baselines are stable.

8) To acquire a test report, click either

•

Analyze

•

Start RR

prepare a RR Variability report.

9) Reports are automatically saved and can be viewed upon exiting the ECG screen by the

button.

10) Reports on the Report Review screen are in chronological order for the patient being tested,

and are displayed on the ECG or RR Variability tabs.

11) Review reports from other patients by clicking

instructs the program to acquire, analyze and store a resting ECG test.

instructs the program to acquire a preset duration of the rhythm strip and

Analyze

Start RR

Patient List

on the menu bar.

Review

IQecg® Operation Manual

C. Appendix C - Upgrading IQmanager® software version 8.5 and earlier

The following describes the changes to the original QTc data in the ECG reports with previous versions of IQmanager® software after this upgrade.

• Information on the old ECG reports will remain the same as long as no changes are

made to the report.

• The original QTc information will no longer be editable. This value will be fixed.

• Add up to two of the four available QTc data to include in the ECG report. See Section

II-D, Configuring IQecg/ECG Settings.

• Changes made to the ECG report that have the original QTc information may remove it

from the report. The general rules of thumb are:

1. Changing the interpretation statement or general measurement values other

than heart rate or QT, will retain the original QTc data. This is to preserve the original QTc value to support the physician’s interpretation. Additional QTc information will be added to the report based on the current selections in QTc 1 and QTc 2 settings.

2. Changing the heart rate or QT value will remove the original QTc data and

replace it by the current selection in QTc 1 and QTc 2 settings. The original QTc value is redundant in this case since QTc will be recalculated based on the new heart rate or QT values.

3. If the report already has the QTc 1 and/or QTc 2 data, any changes to the

report will update the QTc 1 and QTc 2 information based on the current selection in these settings.

• A warning message will appear to inform the user of the changes in QTc data when you

begin to edit the report. Accept the change in order to edit the report.

• Optional: Check “Do not show any New QTc Formula Update message again” to disable

the warning message.

• The original QTc data in the Measurement Matrix will be removed and replaced by the

new QTc 1 and QTc 2 information.

• Accessing the P-QRS-T Calipers will display the QTc information based on the current

QTc 1 and QTc 2 settings. Moving the calipers that measure the QT interval will automatically update the new QTc values according to the specific formula.

IQecg® Operation Manual

• Similar to the original QTc information, the system does not allow the user to change

the new QTc data directly. However, changing the heart rate or QT value will automatically update the new QTc data according to the specific formula.

IQecg® Operation Manual

A format error has occurred in the ECG data collected.

A. The graphics display adapter in the computer is too slow

D. Appendix D - Troubleshooting Guide

This Troubleshooting Guide provides a list of solutions or recommendations to situations that may be encountered with IQecg®. Before calling Midmark Technical Service, please refer to the following table for help. Error messages may be displayed at the center or at the bottom-right corner of the screen.

 NOTE: For errors that occur during the analysis or management of ECG files, please refer to

Troubleshooting section in the IQmanager® Operation Manual.

Troubleshooting Guide

Error Message/Problem Recommendation/Possible Solution

• This error message can be cleared by clicking on Settings, then

Cancel.

• Verify that the Low Battery LED on the ECG Module is not

DATA FORMAT ERROR

Message appears after starting a new ECG.

blinking. If it is, install new batteries.

• Switch to 4 leads display format. Refer to section on Live ECG for

Display setting change instructions.

• Turn off Waveform Smoothing. Refer to section on Live ECG and

Default Interpretation and Acquisition Display settings.

If an error message appears consistently at the beginning of a new ECG, verify that the ECG module is connected to the correct serial port. Refer to Sections II-B and II-D.

DISPLAY DIAGNOSTICS:

Delays in the ECG display have been detected. Click Help to diagnose this problem.

Message appears while running an ECG.

displaying the live ECG for the current display settings.

B. The computer might also be too slow or too busy running other

programs in the background.

C. If running live ECG in a thin-client environment, the bandwidth

maybe too low.

• Click Help and follow the recommendations on the Help screen.

• Verify that the Waveform Smoothing option is off and set to

display in 4 leads display format. This is found under Default Interpretation and Acquisition Display Settings tab on Settings

function.

• Verify no other tasks or programs running.

close all running programs. Restart IQmanager®

restarting the computer.

• If the above fails to correct the problem, disable the Display Real-

time ECG Tracing under Default Interpretation and Acquisition Display Settings tab on Settings function.

Exit IQmanager® and

without

IQecg® Operation Manual

The program cannot communicate with the ECG module because it is

ERROR: THERE MUST BE AT

The ECG

module

cannot communicate with the ECG Acquisition

Troubleshooting Guide

Error Message/Problem Recommendation/Possible Solution

not on, not connected to the computer, or is connected to the wrong port.

NOTE: For Touchscreen Display users: If using the same COM or

ECG MODULE NOT RESPONDING!

Message appears after starting a new ECG test. No ECG tracing is displayed on the screen.

ECG SECURITY KEY NOT FOUND

Message appears after clicking Analyze. This message only appears when using the Valentine PC-ECG module and not with the

IQecg

module.

USB port for the ECG module and the touchscreen display, close or disable the touchscreen driver before running

• Verify that the ECG module is connected to the correct serial

port. Refer to Sections II-B and II-D.

• For Valentine ECG module: Verify that the ON LED on the ECG

module is lit. If not, push the power button.

• For Valentine ECG, verify that the Low Battery LED is not blinking.

If it is, install new batteries.

• For IQecg® module

green. If the LED is red, install new batteries. If there is a symbol on the module, it may be necessary to press it to turn the power on.

IQmanager® cannot

because it is either not installed or there is a conflict with the parallel port.

• Verify that the Security Key is installed directly on the parallel

(printer) port of the computer and that the printer cable is connected to the back of the Security Key. Ensure that the printer is on and ready (or online).

• Print from Windows Notepad or any text file to verify the parallel

port is working properly with the Security Key installed.

: Verify that the LED on the top cover is

find the Security Key for the Valentine PC-ECG

the IQecg®

program.

LEAST 2 REPORTS FOR SERIAL COMPARISON /TRENDING.

Message appears after clicking the Serial

Comparison button.

SERIAL PORT ERROR! EXIT.

Message appears after starting a new ECG. No ECG trace is displayed on the screen.

Serial Comparison in ECG requires at least 2 ECG reports completed under the same patient.

• Click OK. Perform additional test if needed.

module; it is either connected to the wrong serial port or the configuration is incorrect.

NOTE: For Touchscreen Display users: If using the same COM or

USB port for the ECG module and the touchscreen display, close or disable the touchscreen driver before running

• Refer to Sections II-B and II-D for COM port selection and setup.

Use Auto Detect to find the correct COM port.

IQmanager®.

IQecg® Operation Manual

•

Depending on

the computer, print jobs may be slower if the ECG

Troubleshooting Guide

Error Message/Problem Recommendation/Possible Solution

Details button does not work

in the ECG Report Review screen.

Incorrect diagnostic interpretation.

No error message and no ECG trace on Live ECG screen.

Prints slowly when printing live ECG tracing or printing automatically after analysis.

1. Exit

2. Start MS-DOS Prompt.

3. Change directory to c:\windows\system (if Windows NT,

4. Type regsvr32 msflxgrd.ocx and press Enter

5. Type regsvr32 oleaut32.dll and press Enter

Refer to ECG signal quality problems above.

• Patient’s Date of Birth, Sex and Medications must be accurately

•

• Refer to ECG MODULE NOT RESPONDING above.

•

module is still actively collecting live ECG data.

• Click Freeze before printing the ECG tracing displayed on the

• Verify that Print after Analysis is not checked. Refer to ECG

•

IQmanager®.

c:\winnt\system32)

Exit MS-DOS Prompt and restart the

entered. Refer to Section III-E, Testing a New Patient. Edit the diagnostic statements accordingly. See Section III-E,

Reviewing Patient Reports/ECG Report Review.

Refer to SERIAL PORT ERROR above.

screen. Refer to Section III-E, Live ECG.

Settings, Section II-D, Configuring IQecg/Printer Settings and RR

Variability Settings.

Uncheck Grid setting. Printing ECG reports without the grid will expedite the print jobs.

IQecg® application.

IQecg® Operation Manual

•

Inspect connections between the electrodes, clips, lead wires, lead

•

Troubleshooting Guide

Error Message/Problem Recommendation/Possible Solution

For a good signal quality, the patient must be properly prepped;

the lead placements correct and the electrodes and lead wires firmly secured. See Section III-B, Patient Preparation for best practices.

• For the Valentine ECG: Verify that the Low Battery LED on the ECG

module is not blinking; if it is, install new batteries.

ECG signal quality problems such as a low amplitude, wandering baseline, noisy signal, etc.

All other operational problems.

• For

• Verify that the electrodes are fresh, moist, and sticky, not dry or

• Verify that the patient lead wires and cables are not damaged or

•

• The exam room should not be too cold; patient may shiver,

• If any I, II, III, aVR, aVL and aVF leads on the screen are noisy or

• Test the filter settings on the ECG screen. Turn AC filter ON if you

•

• Click INST to reset the baselines or manually restart the ECG

• Verify patient’s bed is properly grounded.

•

• Additional troubleshooting covering ECG diagnostics is available in

•

the IQecg®

message displayed. If it is, install new batteries.

hard. Check electrode expiration date on package.

worn out.

cable and the ECG module.

causing a noisy signal.

flat-lined, check the limb lead electrodes for proper contact in this order: RL, LL, RA and LA. If a precordial lead is noisy or flat-lined, check the limb lead electrodes first, and then check the corresponding chest lead electrode for proper contact. Once identified, discard and replace the used electrode. Prepare the problem site again or try a new electrode site in close proximity to the original site. Note any site variance on test report.

see 50/60Hz noise. Turn MYO filter ON if patient produces muscle tremor. Turn Drift filter ON if the ECG baseline is drifting. While these digital filters can improve signal quality, they cannot correct hookup problems.



NOTE: As with any ECG measuring device, turning on the MYO

filter may alter measurements, which may affect the diagnostic statements. Do NOT turn on the MYO filter for pacemaker patients.

module.

Verify patient or examination room is not susceptible to energy interference such as electromagnetic fields from high-power equipment like X-ray machines, power generators, power compressors, etc.

Click Help found on all screens for the online help.

the

IQmanager®

Contact Midmark Technical Service at 1-800-624-8950, option 2, or see the Contact Information at the end of this manual.

: Verify that the LED is not red nor the Low Battery

Operation Manual.

Maintenance and Storage of the ECG Module

occur

there is no visible damage to the unit that may cause it to malfunction.

Visual inspection should include the

rioration, including but not limited to cracks, cuts, discoloration or oxidation.

other accessory exhibits any of these symptoms, replace it prior to using the ECG module.

Clean the outside of the ECG module with a mild solution of

Avoid using excessive amounts of solution, which may infiltrate the connectors, battery

If necessary, use a mild sterilizing detergent with low alcohol

generally use

Verify that all equipment, including accessories,

Do not use aromatic hydrocarbons, rubbing alcohol, or chlorinated solvents for

cleaning the ECG module.

during storage.

: To prevent damage to

module will not to be used for a long period of time.

possible

cable or the patient cable.

hanger to accommodate safe storage when not kept in the carrying case.

devices can be damaged by exposure to liquids.

near any type of liquids

IQecg®

Operation Manual

prior to each use of the ECG module to verify that

module and all cables for signs of damage and

detergent and water using a soft

module due to battery leakage or oxidation,

module by the interface

constructed with a study, built

use or store

E. Appendix E -

Preventative Inspection

A preventative inspection should

dete

Cleaning

cloth. compartments or ECG module. content, such as those



CAUTION:

ECG

If a cable or

d in hospitals.

is completely dry before using.

Storage

Avoid extreme humidity and heat

If applicable remove all batteries if the



CAUTION: To prevent

 CAUTION: Electronic

the IQecg®

damage, do not hang the IQecg®

The module is

-in

Do not

IQecg® Operation Manual

F. Appendix F - Maintenance and Storage of 10-Lead Resting ECG Patient Cable

Instructions for Use

• Check the cable integrity before each use. In case of damage of any kind, do not use and do

not attempt to repair cable. Contact Midmark Technical Service for a replacement cable. If cable is found to be contaminated, clean and disinfect it according to instructions below before reusing.

• Plug the 10-Lead Resting ECG Patient Cable to the IQecg® module as described in Section II

of this IQecg® Operation Manual – Figure 2-2. Make sure the connection is tight. Check the connection before each use.

• Plug the metal post of each lead of the patient cable into an ECG clip. Make sure each ECG

clip is pushed all the way in.

• If experiencing signal disturbance, distortion or interruptions, stop the procedure and

localize the source of the problem and correct before continuing.

• At the end of the procedure, gently disconnect the ECG clips from the electrodes. o Do not remove the patient cable from the ECG module.

• All cables should be stored in big loops. Tight coiling must be avoided. Also avoid heat

sources and direct sunlight.

Cleaning

Cables are supplied non-sterile and are reusable. For cleaning and disinfection the following substances and procedures must be used:

• Disconnect cable. Wipe plastic parts with a cloth moistened in lukewarm water with

alcohol-free neutral soap. Always wipe towards the patient connectors/ECG clips.

• Proceed carefully as to not damage the cable through excessive stretching, bending or

kinking of the wires.

• Remove the cleaning agent by wiping the cable with a cloth moistened in water. Wipe or

air dry before use.

• Remove adhesive residues only with the alcohols listed below. Never use other organic

solvents (acetone or toluol will damage the cable jacket).

Disinfection

Clean cables before each disinfection as described above. Perform wipe disinfection using products with the following substances as active ingredients:

IQecg® Operation Manual

• Ethyl or Isopropyl alcohol 70 – 80%

• Glutaraldehyde 2 % (pH 7.5 - 8) (e.g. Cidex®)

• Quaternary ammonium compounds (e.g. Sani-Cloth® HB wipes)

Remove the disinfectant immediately after the recommended contact time by wiping the cable with a cloth moistened with water.



CAUTION:

• The ECG patient cable is not suitable for autoclave or UV sterilization!

• Never immerse or soak the cable!

• Prolonged alcohol exposure can negatively affect the mechanical properties of the

cable jacket.

• N-propyl alcohol or sodium hypochlorite (bleach) should be avoided for the

disinfection of the cables!

G. Appendix G - Radio and Television Interference

This equipment generates and uses radio-frequency energy. If not installed and used properly in strict accordance with the manufacturer’s instructions, it may cause interference to radio and television reception.

This equipment has been tested and proved to be in compliance with the standards for medical devices and in accordance with the IEC 601-1 rules, which are designed to provide reasonable protection against such interference in a medical or hospital environment.

H. Appendix H - EMC Requirements for the IQecg®

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this section.

Portable and mobile RF communications equipment can affect the operation of medical electrical equipment. The IQecg® is medical electrical equipment.

The following is a list of the Midmark cables and other accessories that are used as part of the IQecg® that comply with sections 36.201 and 36.202 of the EMC Standard IEC60601-1-2 (E):

• ECG Model(s) IQecg®

• Patient cables: Approved Midmark cables with 4mm banana connectors or pinch leads

Use of cables, cable extensions or accessories other than those specified, with the exception of cables and accessories sold by the manufacturer of the IQecg® as replacement parts for

IQecg® Operation Manual

Emissions Test

Compliance

Electromagnetic environment

– guidance

RF emissions

Group 1

RF emissions

Class B

Harmonic Emissions

N/A Battery operated device

(serial version module

Voltage fluctuations

N/A Battery operated device

(serial

version module

internal components, may result in increased EMISSIONS or decreased IMMUNITY of the IQecg®.

Guidance and manufacturer’s declaration – electromagnetic emissions

The IQecg® is

customer or the user of

intended for use in the electromagnetic environment specified below. The

the IQecg®

should assure that it is used in such an environment.

CISPR 11

IEC 61000-3-2

/ flicker emissions IEC 61000-3-3

The IQecg®

internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic environment.

The IQecg®

establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

only)

uses RF energy only for its

is suitable for use in all

IQecg® Operation Manual

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment

–

Electrostatic

±6 kV contact

Floors should be

wood, concrete

Electrical fast

±2 kV for power

N/A

Battery

operated device

Surge

±1 kV differential

N/A Battery

operated device

Voltage dips,

<5% U

N/A Battery

operated device

Power

Power frequency magnetic fields

NOTE

: UT

is the A.C. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity

The

IQecg® is

or the user of

intended for use in the electromagnetic environment specified below. The customer

the IQecg® should

assure that it is used in such an environment.

guidance

discharge (ESD)

IEC 61000-4-2

transient/burst

IEC 61000-4-4

IEC 61000-4-5

short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

±8 kV air

supply lines

±1 kV for input/output lines

mode

(<95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (<95% dip in UT) for 5 sec

±8 kV air

±1 kV for input/output lines

or ceramic tile. If floors are covered with synthetic materials, the relative humidity should be at least 30%.

frequency (50/60 Hz) magnetic field

IEC 61000-4-8



3 A/m

should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IQecg® Operation Manual

Immunity test

IEC 60601 test

NOTE

Guidance and manufacturer’s declaration – electromagnetic immunity

The IQecg®

or the user of

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3



NOTE 2:

absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and

land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the IQecg® is used exceeds the applicable RF Compliance level above, the IQecg® should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the IQecg®

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

is intended for use in the electromagnetic environment specified below. The customer

the IQecg®

level

should assure that it is used in such an environment.

Compliance

Electromagnetic environment – guidance

level

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

At 80 MHz and 800 MHz, the higher frequency range applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by

3 Vrms

3 V/m

Portable and mobile RF Communications equipment should be used no closer to any part of the IQecg®, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2 √ P

d = 1.2 √ P 80 MHz to 800 MHz

d = 1.2 √ P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from the fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b

Interference may occur in the vicinity of equipment marked with the following symbol:

IQecg® Operation Manual

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation

Recommended separation distances between portable and mobile RF communications equipment and the IQecg®

The IQecg® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the IQecg® can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the IQecg® as recommended

below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter

Separation distance according to frequency of transmitter

d = 1.2 √ P

d = 2.3 √ P

distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

Safety and International Symbols

The following symbols are used on Midmark products.

Refer to this directory for

Follow instructions for use.

Year manufactured

–

This device uses 5 Volt power and consumes 80mA when in use.

–

This device uses 3 Volt power and consumes

BATTERY ORIENTATION

This device uses 2 AA a

batteries to be insta

IEC-601 Defibrillator

Equipment displaying this symbol contains an F

applied part that provides a high degree of protection against electrical

shock, and is suitable for use during defibrillation.

ETL Listing Mark.

Equipment displaying this symbol has been tested and complies with the

following safety standards:

Conforms to

Certified to CAN/CSA S

Do not dispose of this product as unsorted municipal

product in accordance with national requirements per EC Directive 2002/96.

YYYY

IQecg

These symbols appear on products

details concerning the symbols used on equipment.

–

lkaline batteries. The icon indicates the orientation of

proof Type CF equipment.

type isolated (floating)

waste. Dispose this

Operation Manual

I. Appendix I -

when applicable.

Symbol Description

DC VOLTAGE

(USB CONNECTION DEVICES)

(SERIAL CONNECTION DEVICES)

80mA when in use.

- (SERIAL CONNECTION DEVICES)

lled.

•

DISPOSAL

UL Std 60601-1

td C22.2 No. 601.1

IQecg® Operation Manual

VI. IQecg® Service Manual

A. Introduction

The Midmark IQecg® is a PC-based diagnostic instrument that converts any Windows-based personal computer to a 12-lead electrocardiograph with interpretative and data storage capabilities. A complete IQecg® system consists of the ECG data acquisition module, the PC system, including a monitor and printer, Microsoft Windows operating systems (Windows® 8, or 7, and IQmanager® software program.

This manual is provided to assistance primarily with service of the IQecg® data acquisition module. For information regarding the operation of the IQecg®, please consult the IQecg® Operation Manual; for information about the service and operation of the PC system, please consult your PC’s documentation.

B. Theory of Operation

The IQecg® data acquisition module is an improved version of previous hardware modules.

Some features for the IQecg® data acquisition module include:

• Built-in defibrillation protection circuit

• Hardware lead-off detection circuit

• Hardware pacemaker detection circuit

• Analog bandwidth from 0.05Hz to 150 Hz

• Digital sample rate of 500 Hz

• USB computer interface or RS-232 Serial COM port interface

IQecg® Operation Manual

Lead Off Detector

10- Leadwire

Patient

Patient Cable

with Defib Protection

8-Channel A/D

Converter

ECG Buffer

Amplifiers

Microcontroller

Figure 6-1 System Block Diagram

10-Leadwire Patient Cable

Pacemaker

Detector

Instrumentation

Amplifiers

Isolated Serial

Interface

DC-DC Power

Circuit

Filters and Gain

amplifiers

PC System

The IQecg® uses the special Midmark 10-Leadwire patient cable for its 12-lead ECG data acquisition. The patient cable has 10 conductor shielded lead wires. There is a 1Kohm (±10%) resistor embedded inside each lead wire. Together with the voltage clamping circuit built into the ECG front end, the IQecg® provides the built-in defibrillation protection capability required by AAMI EC-11 and IEC-60601.

ECG Buffer Amplifiers

The patient ECG signals are first fed to the 8 ECG buffer amplifiers. These buffer amplifiers provide high input resistance for the patient interface with low output resistance to the instrumentation amplifiers.

Instrumentation Amplifiers

There are eight differential instrumentation amplifiers used in the IQecg®, providing eight output signals from CH0 to CH7. Each differential amplifier has two inputs, one positive and one negative.

IQecg® Operation Manual

The following table lists the positive and negative inputs for each channel.

Channel Number Positive Input Negative Input

CH0 LA RA CH1 LL RA CH2 V6 Wilson Center CH3 V5 Wilson Center CH4 V4 Wilson Center CH5 V3 Wilson Center CH6 V2 Wilson Center CH7 V1 Wilson Center

The Wilson Center is a reference point combined with the three limb leads. The purpose of the instrumentation amplifier is to provide a high Common Mode Rejection Ration (CMRR), rejecting common mode signals such as 60 Hz line noise.

Filters and Gain Amplifiers

After the instrumentation amplifiers, the 8-channel ECG signals are passed into two stages of filters. The first stage consists of eight first-order high-pass filters with a cutoff frequency of

0.048Hz. The second stage consists of eight low-pass filters with a cutoff frequency of 159Hz. The ECG signals are also amplified to match the AD converter input dynamic range of 0-2.5V.

There are eight test points provided on the PCB board. The test points are labeled as CH0, CH1, CH2, CH3, CH4, CH5, CH6 and CH7. The signals measured on these test points are amplified with a gain of 125 and DC offset to 1.25Volt.

Analog to Digital Conversion

The AD converter used is ADC12138 from National Semiconductor. The AD converter is 12-bit plus sign serial I/O A/D converter with MUX and Sample/Hold. The amplified and filtered 8channel ECG signals are passed to the 8-channel inputs of the AD converter. The sampling rate for each channel is 500Hz. The digitized ECG data are sent to the microcontroller through the serial interface.

Microcontroller

The microcontroller is a PIC16LC67 chip from Microchip Technology. This chip has 8Kx14 OTP, 33 I/O lines and built-in serial interfaces for A/D converter and RS232. The microcontroller receives the digitized ECG data from the AD converter and encodes the data with packets and sends out to the PC through serial interface circuitry. The setting for the RS232 is 8 bit data, 1 bit stop, no parity, and 115,000-baud rate and is usually handled automatically. Settings for USB are automatic and are not user selectable.

IQecg® Operation Manual

Isolated Serial Interfaces

To provide the maximum safety for the patient, the IQecg® hardware and the PC are isolated with an optical coupler and/or isolated DC to DC converters. The serial signal sent out by the PIC microcontroller is coupled optically to the PC system either through the RS232 or USB interface. There is no electrical connection between the patient and the PC system. The isolation circuit can withstand up to 1000Volts.

Lead-Off Detector

The IQecg® has a built in lead off detection circuit. The lead-off circuit senses the lead off condition and reports to the PIC microcontroller. The PIC microcontroller sends out the lead off condition to the PC through the serial interface.

Pacemaker Detector

The pacemaker detection circuit in the IQecg® ensures the device’s capability of printing the ECG signal in the presence of pacemaker pulses with amplitudes between 2 and 250 mV, duration between 0.1 and 2.0 ms recommended by AAMI EC-11.

DC-DC Power Converter

The Serial / RS232 model of the IQecg® uses two AA batteries to supply its power.

The USB model of the IQecg® devices does not require the use of batteries. The USB port of the host computer provides the operating power. A step up DC-DC converter is used to provide a 4.5Volt power source. Two 3.3Volt regulators are used to provide two 3.3Volts power source for the analog circuits and digital circuit for the unit. There is also a negative voltage converter used to generate a 3.3Volt power source for the analog circuit. A Linear Technology 1.25Volt micropower shunt reference regulator provides precision 1.25Volt reference voltage.

Isolation is provided for signals entering the ECG module and can withstand up to 1000Volts.

IQecg® Operation Manual

C. System Maintenance and Obtaining Service

The IQecg® is a portable device and requires little maintenance. To ensure the best performance of the device, the following procedures are recommended:

• Keep the patient cable clean.

• Do not unplug the patient cable from the IQecg® hardware.

• When the device LED turns red or the computer screen displays low battery, (45 Series

/ RS232 version only) replace the batteries inside the unit before continuing.

The IQmark and IQecg Digital ECG acquisition modules contain no user adjustable or serviceable parts and are designed to operate without adjustment for the lifetime of the product.

However, electronic equipment can be subject to wear and damage that can cause malfunctions. A certification policy is the responsibility of the end user and is subject to the end users’ business practices which may require it. Certification provides peace of mind that the device continues to work within factory specifications. Certifications can be purchased directly from Midmark.

Please contact Technical Service at 800-624-8950, option 2, with questions or to make arrangements for the certification of an IQmark® Digital ECG or IQecg® Digital ECG device.

 NOTE: Return authorization is required prior to the return of the device. Midmark

Technical Service will issue a Return Materials Authorization (RMA) number prior to shipment.

IQecg® Operation Manual

VII. Customer Support and Warranty Information

For immediate help diagnosing problems with this product, refer to the online Help or

Appendix C, Troubleshooting Guide.

For help diagnosing problems by phone with this product, contact Midmark Technical Service at (800) 624-8950, option 2, between 6:00 AM to 4:00 PM, Pacific Standard Time.

To contact Midmark Technical Service via email: techsupport@midmark.com

Self-help knowledge base and live chat can be accessed at: kb.midmark.com

Warranty

Midmark warrants IQecg® to be free from manufacturing and material defects for 12 months from the date of purchase. Accessories and patient cables for IQecg® are warranted for 90 days. Any misuse or abuse of a Midmark product voids all applicable warranties.

Please refer to midmark.com for the full and current Warranty Terms and Conditions.

Return Materials Authorization

To return any product for repair, a Return Materials Authorization (RMA) number must be obtained from Midmark Technical Service. This RMA number should be referenced on the package(s) containing the items to be returned and in any correspondence regarding the return.

Shipping

Before shipping any unit to Midmark, be certain that an RMA number has been issued and that all guidelines regarding this authorization are followed. We highly recommend following all guidelines for the shipment of medical products set forth by the shipping company you choose to use. If a question should arise regarding the appropriate method of shipment, please feel free to ask when calling for your RMA number. It is the responsibility of the customer when shipping a product to ensure that all packages and their contents get to Midmark safely. Midmark will not assume responsibility for damage due to improper packaging, shipment or product use. Such actions will void all applicable warranties.

Midmark Corporation

690 Knox Street, Suite 100

Torrance, California 90502

Tel: (310) 516-6050

USA: (800) 624-8950, option 2

Fax:(310) 516-6517

VIII. Contact Information

Midmark Corporation 690 Knox Street, Suite 100 Torrance, California 90502 Phone: (310) 516-6050 USA: (800) 624-8950, option 2 Fax: (310) 516-6517 Email: techsupport@midmark.com Website: midmark.com Knowledge base: kb.midmark.com

IQecg® Operation Manual

Midmark IQecg User manual

Specifications and Main Features

Frequently Asked Questions

User Manual