Spaulding webECG Diagnostic ECG Management Solution … · AHA Lead Placement ... Electrode placement ... patients are ambulatory, however ECG’s are taken in a resting supine position

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

Part Number 9920-101-10-eng March 2013 V1.2

Spaulding webECG™ Diagnostic ECG Management Solution with the Spaulding Electrocardiograph

Clinical Reference Guide

Contact InformationHeadquartersSpaulding Clinical Research, LLC 525 South Silverbrook Drive West Bend, Wisconsin 53095 USA

Tel: 262.334.6020 Fax: 262.334.6067 Internet: www.spauldingclinical.com

European Union RepresentativeWellkang Ltd Suite B, 29 Harley Street LONDON, W1G 9QR UK

Tel: +44(20)32876300 Fax: +44(20)76811874 E-mail 1: [email protected] (shared and preferred for receiving emails)

E-mail 2: [email protected] (shared)

Sales SupportSpaulding Clinical Research, LLC 525 South Silverbrook Drive West Bend, Wisconsin 53095 USA

Tel: 262.306.3348 (Client Services) Tel: 262.334.6020 Fax: 262.334.6067

E-mail: [email protected]

Client Services Technical Support, Supplies and AccessoriesSpaulding Clinical Research, LLC 525 South Silverbrook Drive West Bend, Wisconsin 53095 USA

Tel: 888.607.7871 Tel: 262.306.3348 (Client Services) Tel: 262.334.6020 (Main Switchboard) Fax: 262.334.6067 E-mail: [email protected]

This document contains confidential information that belongs to Spaulding Clinical Research, LLC. No part of this document may be copied, transmitted, used, or disclosed outside of the intended recipient without the written approval of Spaulding Clinical Research, LLC.

NOTE: Microsoft and Windows operating system are registered trademarks of Microsoft Corporation in the United States and other countries.

EC REP

Additional Contact InformationSpaulding Clinical Research, LLC

Local Representative: ____________________________

Address: ______________________________________

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Tel: __________________________________________

Fax: _________________________________________

http://www.spauldingclinical.com

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iContents

Contents

System InformationIntroduction .................................................................................................................... 1

Definitions...............................................................................................................................................................1Clinical Reference Guide Purpose ...................................................................................................................... 2System Description .............................................................................................................................................. 2System Purpose ................................................................................................................................................... 2Intended Users ...................................................................................................................................................... 3Indications for Use – Spaulding Electrocardiograph ........................................................................................ 3Indications for Use – webECG ............................................................................................................................ 3Patient Population ................................................................................................................................................ 3Environment .......................................................................................................................................................... 4Methods and Frequency of Use .......................................................................................................................... 4

Notifications .................................................................................................................. 5Manufacturer’s Responsibility .............................................................................................................................5Responsibility of the End User ............................................................................................................................5Spaulding Electrocardiograph Serial Number Identification ............................................................................5Copyright and Trademark Notices ......................................................................................................................5Other Important Information ................................................................................................................................5

Limited Warranty ......................................................................................................... 6Equipment Symbols and Markings.................................................................................7User Safety Information ............................................................................................... 8

WARNINGS .............................................................................................................................................. 8

CAUTIONS ............................................................................................................................................. 10NOTES .................................................................................................................................................................. 11

System Description ..................................................................................................... 12Spaulding Electrocardiograph ..................................................................................... 13

LED Status Window Indicators ...........................................................................................................................15

Equipment PreparationEquipment Preparation ................................................................................................ 17

LED Status Window .............................................................................................................................................17Charging the Battery via Display Device...........................................................................................................17

Preparing the Patient for 12-lead ECGPreparing the Patient ................................................................................................... 19

Preparing Patient Skin for ECG Hookup ...........................................................................................................19Electrode Location Preparation .........................................................................................................................19

Electrode Placement ................................................................................................... 20AHA Lead Placement .........................................................................................................................................20IEC Lead Placement ...........................................................................................................................................21Leadwire Color Identification ............................................................................................................................ 22

ii Contents

Contents

Acquiring a 12-lead ECG with Physician OrdersData Collection and Transfer Using a Physicians Order ............................................ 23ECG Data Transfer to Display Device ......................................................................... 25

New Order ........................................................................................................................................................... 29View ECG .............................................................................................................................................................30

Off-line Mode ............................................................................................................... 31Orders ......................................................................................................................... 33

Acquiring a 12-lead ECG with Voice Demographic Association

Data Collection and Transfer Using Voice .................................................................. 35Recording ECG and Voice Data .........................................................................................................................35ECG Data ............................................................................................................................................................. 37Re-Record Voice Signature Data ...................................................................................................................... 37

ECG and Voice Signal Data Transfer to Display Device ............................................. 38New Patient Enrollment .....................................................................................................................................39Existing Patient Process .....................................................................................................................................41View ECG .............................................................................................................................................................44

Off-line Mode .............................................................................................................. 45

Review ECG DataECG Data ......................................................................................................................47

Review Patient Record ...................................................................................................................................... 47Review 12-lead ECG Report ............................................................................................................................... 48Review Full Disclosure Waveforms ..................................................................................................................50

webECG Report ............................................................................................................51Review webECG Report ......................................................................................................................................51

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Contents

Physician Tool KitOver-read of the 12-lead ECG using the Spaulding Physician Tool Kit, web-based application ................................................................................................ 55ECG Over-Read Process ............................................................................................. 56

Step 1: Examine the 12-lead ECG ......................................................................................................................56Step 2: Measure Intervals .................................................................................................................................. 57

Perform Comparison ................................................................................................... 59Interpret the Full Report ............................................................................................. 60Assess Arrhythmia ..................................................................................................... 63Acronyms .................................................................................................................... 65

Site Configuration & ManagementSpaulding webECG Site Configuration and Management ............................................67

Logging In ............................................................................................................................................................ 67Creating and Managing Users ........................................................................................................................... 67Editing Patient Demographics ........................................................................................................................... 72

SuppliesSpaulding Electrocardiograph Supplies ...................................................................... 75

Maintenance & TroubleshootingGeneral Care and Cleaning Instructions ......................................................................77

General Care ....................................................................................................................................................... 77Cleaning the Patient Cable and the Spaulding Electrocardiograph ............................................................... 77Methods .............................................................................................................................................................. 77

Troubleshooting ...........................................................................................................78LED Status Window Display Code Troubleshooting ....................................................................................... 78Voice Signature Data Troubleshooting ............................................................................................................. 79ECG Data Troubleshooting................................................................................................................................. 79Troubleshooting the Display Device .................................................................................................................80Password Login Errors ......................................................................................................................................80Spaulding Electrocardiograph Specifications ...................................................................................................81

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Software InstallationDisplay Device and Mason Workflow Protocol Specifications ................................... 83

Minimum Display Device Specifications .......................................................................................................... 83Display Device .................................................................................................................................................... 84Mason Protocol Specifications .......................................................................................................................... 84

webECG Management Specifications .......................................................................... 85Cloud-Based Server Environment ....................................................................................................................85Web Browser Requirements .............................................................................................................................85Physician Tool Kit Site Application Requirements ..........................................................................................85webECG Application ........................................................................................................................................... 86

Electromagnetic Compatibility .....................................................................................87Spaulding Client App (Application) .............................................................................. 91

Site Configuration ................................................................................................................................................91Minimum Display Device Specifications ...........................................................................................................91Spaulding Client App Software Installation ......................................................................................................91Display Device User Identification and Access Permission........................................................................... 92

Physician Over-read Tools Software Installation ........................................................93Physician Credentials and Work Assignments: ............................................................................................... 93Initial Set Up ........................................................................................................................................................ 93

IndexIndex .............................................................................................................................. I

1System Information

System Information

Introduction

DefinitionsDescription Definitions

Main Function Button The user interface button on the Spaulding Electrocardiograph

LED Status Window The user message window on the Spaulding Electrocardiograph

Display Device A commercially available off the shelf computing device, fixed or mobile, wired or wireless, with network capabilities, compatible with the Spaulding Client Application and capable of accessing the Spaulding webECG server components.

Electrocardiograph The Spaulding Electrocardiograph device used to collect a diagnostic 12-lead ECG and biometric voice data.

Mason Workflow Protocol A Spaulding Client Application that allows customizing the system to optimize the data collection workflow for collection of a 12-lead ECG to increase the quality of the data collected.

Spaulding Client Application

A software application that interfaces with the Spaulding Electrocardiograph, using the Mason Workflow Protocol. It transmits ECG, voice, and associated metadata (i.e. demographics) to the webECG server.

Spaulding webECG Diagnostic ECG Management Solution

A server software suite of modules for ECG data management, ECG data analysis utilizing 3rd party commercial off-the-shelf ECG algorithms, web dashboard interface, reporting capabilities, external EHR interface capabilities, and Spaulding Physician Tool Kit for ECG over-read.

Third Party Applications Participating third party commercial off-the-shelf software providing a central database for ECG/ Voice records, supporting the server and/ or web-based features and functions of the system including ECG and Voice analysis.

Patient/Subject: Patient is an interchangeable term sometimes referring to subject.

Spaulding Client App Icon This icon resides on the client’s display device desktop and launches the Spaulding Client Application.

Spaulding Physician Tool Kit App Icon

This icon resides on the client’s display device desktop and launches the Spaulding Physician Tool Kit Application.

Spaulding webECG bookmark Icon

Icon varies in appearance depending on the browser in use.

This icon resides on the client’s display device desktop. This icon launches the Spaulding webECG web page for login.

2 System Information

System Information

Clinical Reference Guide PurposeThis Clinical Reference Guide is intended to provide the user with information about:

■ Using and understanding the Spaulding webECG™ Diagnostic ECG management solution

■ Function and features of the Spaulding webECG Physician over-read tools

■ Function and features of the Spaulding Electrocardiograph

■ Preparation of the Spaulding Electrocardiograph

■ Patient preparation

■ Electrode placement

■ Acquiring and storing ECG and Voice Signal Data on the Spaulding Electrocardiograph

■ Transmitting ECG and Voice Signal Data to the display device

■ Installing, using, and understanding the Spaulding Client App

■ Maintenance and troubleshooting

WARNING: The Spaulding Electrocardiograph captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis.

System DescriptionThe Spaulding webECG Diagnostic ECG management solution includes the following components:

■ A Spaulding Electrocardiograph that can, acquire a patient 12-lead ECG along with voice data. Data transfers from electrocardiograph to display device via USB Cable.

■ The Mason Protocol, a Spaulding Clinical software application that runs on a display device, receives ECG along with voice data from the electrocardiograph and communicates bidirectionally to the Spaulding webECG server to upload ECG along with voice data via internet connection.

■ A web-based suite of applications that manage the upload of ECG and Voice data, provides analysis of that acquired data using 3rd party tools and algorithms, generates diagnostic reports, provides remote access to the stored diagnostic ECGs, webECG reports and Full Disclosure data, site management tools for customizing the system, setup of automated notifications to the care team and remote diagnostics.

■ Optional Spaulding webECG Physician over-read tools application installed on a windows display device with Windows-based operating system.

The complete Spaulding webECG Diagnostic ECG management solution includes the Spaulding Electrocardiograph with the Spaulding 12-lead ECG Patient Cable, USB Cable, and the display device with the Spaulding Client App.

System PurposeThe intended purpose of the Spaulding webECG Diagnostic ECG management solution is to acquire and digitize 12-lead, resting electrocardiograms along with voice data from a patient participating in healthcare procedures or clinical research protocols and to transmit the ECG data to the display device and the Spaulding webECG server where ECG analysis and data reporting tools are employed to provide an unconfirmed ECG report, and the comprehensive Spaulding webECG Report.

3System Information

System Information

Intended UsersThe Spaulding webECG Diagnostic ECG management solution is intended to be used by qualified medical professionals, or trained personnel who are acting on the order of a licensed physician.

Indications for Use – Spaulding ElectrocardiographThe Spaulding Electrocardiograph is a non-invasive prescription device that is indicated for use:

■ The proposed Spaulding Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms.

■ The device is indicated for use for pediatric and adult populations, diseased or non-diseased. The device is not indicated for use for neonatal (birth to 28 days) or infants (29 days up to 2 years).

■ The interpretations of ECG data offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.

■ The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.

■ The device is not intended to be used as a vital signs physiological monitor.

■ It is not designed for out of hospital transport.

■ It is not designed for use in highly invasive environments, such as an operating theatre.

■ The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

Indications for Use – webECGThe Spaulding webECG Diagnostic ECG Management Solution:

■ Supports ECG data storage, retrieval, edit and report from adult and pediatric patients.

■ Data and information are available through onscreen display, printer, email, EHR (Electronic Health Record) results reporting interface or via customized database queries. Available data and information consists of ECG measurements, text, and digitized waveforms.

■ Provides information for qualified clinicians responsible for the diagnosis and treatment of patients with heart disease.

■ Provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including interpretive 12-lead ECG analysis.

■ Calculates multiple metrics based upon acquired ECG data.

■ Is not intended for real-time patient monitoring.

Patient PopulationThe Spaulding webECG Diagnostic ECG management solution is indicated for use for pediatric and adult populations, diseased or non-diseased. The device is not indicated for use for neonatal (birth to 28 days) or infants (29 days up to 2 years). Typically, patients are ambulatory, however ECG’s are taken in a resting supine position.


System Information

EnvironmentThe Spaulding webECG Diagnostic ECG management solution will typically be used in environments such as hospitals, 24/7 clinics, physician’s offices and clinics, or any medical facility participating in a research protocol.

Methods and Frequency of UseThe Spaulding webECG Diagnostic ECG management solution is intended for use by a physician’s order or at a frequency defined within research protocols.

A supplied Spaulding 12-lead ECG Patient Cable connects to the patient with disposable snap-type electrodes (short term Ag/AgCl) applied to the thorax and limbs, and connects to the Spaulding Electrocardiograph for acquisition of ECG data.

The Spaulding Electrocardiograph is also used to collect voice signature data from the patient in order to help correlate 12-lead ECG data with patient demographic information.

5System Information

System Information

Notifications

Manufacturer’s ResponsibilitySpaulding Clinical Research, LLC is responsible for the effects on patient safety and device performance only if:

■ The device is used as outlined within this Clinical Reference Guide.

■ Assembly operations, adjustments, modifications, extensions, or repairs are completed by individuals solely authorized by Spaulding Clinical Research, LLC.

Responsibility of the End UserIndividuals who use any component of the Spaulding webECG Diagnostic ECG management solution are responsible for ensuring correct use.

Spaulding Electrocardiograph Serial Number IdentificationThe Spaulding Electrocardiograph is identified by a unique serial number on the back label of the device. Care should be taken to preserve the integrity of this label to ensure this serial number is not defaced, and to ensure this label is not removed.

Copyright and Trademark NoticesThis Clinical Reference Guide contains information that is protected by copyright. All rights reserved. No part of this Clinical Reference Guide may be copied, transmitted, translated to another language, used, or disclosed outside of the intended recipient without the written approval of Spaulding Clinical Research, LLC.

Other Important InformationThe information in this manual is subject to change without further notice. Spaulding Clinical Research, LLC makes no warranty of any kind with regard to the material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Spaulding Clinical Research, LLC assumes no responsibility for any errors or omissions that may appear in this manual or makes no commitment to update or to keep current the information contained in this manual.


System Information

Limited Warranty Spaulding Clinical Research, LLC hereby warrants that Spaulding Clinical Research, LLC products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s from Spaulding Clinical Research, LLC or an authorized distributor or representative of Spaulding Clinical Research, LLC. The warranty period is defined as twelve (12) months following the date Product is received from Spaulding Clinical Research, LLC (not to exceed 13 months from the date of shipment from Spaulding Clinical Research, LLC). Normal use, service, and maintenance mean operation and maintenance in accordance with appropriate instructions and/or information guides. This warranty does not apply to damage to the Product/s caused by any or all of the following circumstances or conditions:

a. Freight damage;b. Parts and/or accessories of the Product/s not obtained from or approved by Spaulding Clinical Research, LLC;c. Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or

information guides;d. Accident; a disaster affecting the Product/s;e. Alterations and/or modifications to the Product/s not authorized by Spaulding Clinical Research, LLC;f. Other events outside of Spaulding Clinical Research, LLC’s reasonable control or not arising under normal

operating conditions.

THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, FOR ANY PRODUCT/S FOUND UPON EXAMINATION BY Spaulding Clinical Research, LLC TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Spaulding Clinical Research, LLC of any alleged defects promptly after discovery thereof within the warranty period. Spaulding Clinical Research, LLC’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Spaulding Clinical Research, LLC’s principal place or any other place as specifically designated by Spaulding Clinical Research, LLC or an authorized distributor or representative of Spaulding Clinical Research, LLC, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Spaulding Clinical Research, LLC is limited and that Spaulding Clinical Research, LLC does not function as an insurer.

A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Spaulding Clinical Research, LLC is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Spaulding Clinical Research, LLC should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Spaulding Clinical Research, LLC shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold.

EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS CABLES AND ELECTRODES. THE WARRANTY ON REUSABLE PATIENT CABLES AND USB CABLES IS LIMITED TO NINETY (90) DAYS FROM THE DATE OF RECEIPT BY PURCHASER (NOT TO EXCEED 120 DAYS FROM DATE OF SHIPMENT BY SPAULDING CLINICAL RESEARCH, LLC). DISPOSABLE ITEMS (e.g. ELECTRODES AND SINGLE-USE PATIENT CABLES/ELECTRODES) ARE NOT WARRANTED.

EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST SPAULDING CLINICAL RESEARCH, LLC FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND SPAULDING CLINICAL RESEARCH, LLC IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL SPAULDING CLINICAL RESEARCH, LLC BE LIABLE FOR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

7System Information

System Information

Equipment Symbols and Markings

Consult Information for Use

Defibrillator-proof type CF applied part

Microphone for Voice Detection

USB Universal Serial Bus

0086CE Mark

Do not dispose as unsorted municipal waste. Per EC Directive 2002/96, requires separate handling for waste disposal according to national requirements

Consult Information for use. Clinical Reference Guide contains Warnings and Cautions. Failure to adhere to or comply may lead to injury to patient, user or damage to equipment.

EC REPWellkang Ltd Suite B, 29 Harley Street London, W1G 9QR, U.K.

Spaulding Clinical Research, LLC 525 South Silverbrook Drive West Bend, Wisconsin 53095 USA

Keep Dry

LATEX Latex Free


System Information

User Safety InformationThis Clinical Reference Guide provides important information about the use and safety of the Spaulding webECG Diagnostic ECG Management Solution with Electrocardiograph. Please read the following patient and end user safety information before use.

WARNING Means there is the possibility of personal injury to you or others.

CAUTION Means there is the possibility of damage to the device.

NOTE Provides information to further assist in the use of the device.

WARNINGSThis Clinical Reference Guide provides important information about the use and safety of the Spaulding webECG Diagnostic ECG management solution. Deviating from operating procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could result in increased risk of harm to users and/or patients and bystanders, or damage to the Spaulding Electrocardiograph.

The Spaulding webECG Diagnostic ECG management solution captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis.

The Spaulding webECG Diagnostic ECG management solution is intended to be used by qualified medical professionals, trained personnel under the guidance/order of licensed physician. Before attempting to use the Spaulding webECG server for clinical applications the operator must read and understand the contents of this Clinical Reference Guide and other accompanying documents. Failure to do so could result in increased risk of harm to users and patients or damage to the Spaulding Electrocardiograph.

To prevent electrical interference on the 12-lead ECG, keep the patient cable and electrocardiograph a minimum of 3 feet from any AC powered device while recording ECG data.

The quality of the signal produced by the Spaulding Electrocardiograph may be adversely affected by the use of other medical equipment, including but not limited to defibrillators, MRI, and ultrasound machines.

The device has not been designed for use with high-frequency (HF), surgical equipment and does not provide a protective means against hazards to the patient. For proper operation and the safety of users and patients, equipment and accessories must be connected only as described in this Clinical Reference Guide.

The Spaulding Electrocardiograph is neither designed to detect or reject Pacemaker signals. There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used simultaneously with the device; however, disturbance to the signal may occur.

To avoid the possibility of serious injury or death during patient defibrillation, do not come in contact with device or patient cables. In addition, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.

The Spaulding Electrocardiograph is not intended to be connected to patients in need of defibrillation. The electrocardiograph, however, may be used on patients with an implantable defibrillator. The electrocardiograph provides defibrillation protection only when used with a Spaulding 12-lead ECG Patient Cable.

9System Information

System Information

Failure to follow recommended cleaning procedures, or contact with unspecified cleaning materials/disinfecting agents could result in increased risk of harm to users, patients and bystanders, or damage to the device.

Spaulding 12-lead ECG Patient Cable intended for use with the device include series resistors (9K ohm minimum) in each lead for defibrillation protection. 12-lead ECG Patient Cables should be checked for cracks, breakage, or damage of any kind prior to use. Do not use damaged cables, devices, or accessories.

To avoid potential of serious injury or death, conductive parts of the patient cable, electrodes, and associated connections of Type CF applied parts, including the neutral conductor of the patient cable and electrode, should not come into contact with other conductive parts including earth ground.

ECG electrodes could cause skin irritation; patients should be examined for signs of inflammation or irritation. Proper clinical procedures must be utilized to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation or other adverse reactions. Electrodes are intended for short-term use and should be removed from the patient promptly following testing.

To avoid potential for spread of disease or infection, the Spaulding Electrocardiograph, and Spaulding 12-lead ECG Patient Cable should be cleaned before and after each use. To maintain safety and effectiveness, single-use disposable components beyond their expiration date must not be used. All electrodes and single-use cable/electrodes sets should be properly disposed of after use in accordance with applicable requirements. Single-use disposable components (e.g. electrodes, patient cables, etc.) must not be reused.

A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture with air, with oxygen or with nitrous oxide.

The USB input and output (I/O) connector is intended for connection to only those devices complying with IEC 60601-1-1, or other IEC standards (e.g., IEC 60950) as appropriate to the device. To reduce any potential risk of electrical shock to the patient, the Spaulding Electrocardiograph is mechanically designed such that the patient connection and the USB connection cannot be made at the same time.

To maintain designed operator and patient safety, peripheral equipment and accessories that can come in direct patient contact must be in compliance with UL 60601-1, IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-25. Only use equipment and accessories supplied with the device or specified/approved for use by, Spaulding Clinical Research, LLC.

Do not attempt to connect the Spaulding 12-lead ECG Patient Cable to any other device other than the Spaulding Electrocardiograph.

Set the display device to the correct date/time prior to use with the Spaulding Electrocardiograph.

User should run regular virus checks on all display devices that are used with the Spaulding Electrocardiograph to ensure safe/effective operation.

Failure to complete recommended periodic checks/operation/maintenance of equipment can result in increased risk of harm to users and/or patients and bystanders.

Do not operate the equipment if it has been damaged. If equipment is damaged, remove device from service and have device repaired by qualified service personnel.

Do not over or under-tighten connections. Do not force or modify connections/connectors.

The Spaulding webECG Diagnostic ECG management solution does not contain latex, however, Latex allergies can be a serious, potentially life threatening health issue. Those who may be sensitive to latex should not use latex.

To avoid the potential of compromising patient privacy, use appropriate password security measures, avoid sharing User Credentials, logout of applications after use, and use automated logout security features.

Care should be taken to follow proper ECG cable/leadwire connection instructions. Misconnected (e.g. swapped) leadwires can contribute to a physician misdiagnosis.


System Information

Display device settings must accommodate local lighting conditions for readability.

Operation of the device when user is distracted, fatigued or under the influence of alcohol/drugs can result in increased risk of harm to users and/or patients and bystanders.

Excessive patient movement could interfere with the operation of the Spaulding Electrocardiograph ECG data collection. Ask the patient to remain still during the ECG data collection period.

CAUTIONSNo user calibration or special equipment is needed for the proper operation or maintenance of the Spaulding webECG Diagnostic ECG management solution.

The Spaulding Electrocardiograph and display device have no serviceable parts and calibration is not required.

Do not use sharp or hard objects to depress Spaulding Electrocardiograph button; use only fingertips.

Do not attempt to clean the device or 12-lead ECG Patient Cables by submersing into any liquid, autoclave, or steam cleaning as this may damage the Spaulding Electrocardiograph and accessories.

When necessary, dispose of the Spaulding Electrocardiograph and Spaulding 12-lead ECG Patient Cable in accordance with local regulations.

The Spaulding Electrocardiograph will go into a sleep mode to preserve the battery life after a period of inactivity. A completed recording (voice and ECG) is retained indefinitely in the case of a depleted battery.

Electrodes should be stored in an air-tight container. Electrodes will dry out if not stored properly which will cause loss of adhesion, loss of conductivity, and poor quality ECG data.

Use care when connecting the 12-lead ECG Patient Cable and USB Cable to the Spaulding Electrocardiograph to ensure the appropriate connection is established and that the connector pins are not damaged or bent.

Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Spaulding 12-lead ECG Patient Cable should be stored with the Spaulding Electrocardiograph after forming a loose loop in the cords.

To protect the Spaulding Electrocardiograph and keep it operational, store device/accessories in a dust-free environment, non-accessible to children or pets.

The Spaulding Electrocardiograph is intended to be used in a controlled environment, and should be used and stored according to the published environmental specifications.

To maintain safe and effective operation of equipment, peripheral equipment and accessories that come in direct patient contact must be in compliance with UL 60601-1, IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-25. Only use equipment and accessories supplied with the device or specified/approved for use by, Spaulding Clinical Research, LLC.

All demographic setup changes, except the “Collection Options” column impact the existing database so use caution when making modifications. Please contact Spaulding Clinical Client Services Technical Support at 888-607-7871 or 262-306-3348 with any questions as changes impact the entire database for your organization.

Excessive patient movement could interfere with the operation of the Spaulding Electrocardiograph ECG data collection. Ask the patient to remain still during the ECG data collection period and eliminate additional background noise during the voice recording.

11System Information

System Information

NOTESAs defined by IEC 60601-1 and IEC 60601-2-25, the Spaulding Electrocardiograph is classified as follows:

■ Internally powered equipment.

■ Type CF defibrillation-proof applied parts.

■ Ordinary equipment.

■ Equipment not suitable for use in the presence of a flammable anesthetic mixture.

■ Continuous operation.

Proper patient skin preparation is important to correct application of ECG electrodes and operation of the device.

The device will automatically turn off (blank screen) if the batteries have been severely discharged.

After operating the device using battery power, connect to the display device to charge C the battery.

The Spaulding Electrocardiograph is distributed ready to use. No further assembly is required by the end user.

The Spaulding Electrocardiograph firmware is managed through the Mason Protocol. When authorized, updates to the firmware occur automatically upon connection to the Mason Protocol. The electrocardiograph firmware version is documented in the patient record.

4LD7

MEDICAL EQUIPMENTWITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLYIN ACCORDANCE WITH UL 60601-1,IEC/EN 60601-1, CAN/CSA C22.2 No. 601.1, AND IEC 60601-2-25

This device is UL Classified.

For proper installations download the latest version of Java go to http://www.java.com/download, once complete the display device is ready for initial set up.

Healthcare agency/organization users that access the webECG system expected to be trained and signed off on HIPPA compliance before gaining access into the system.


System Information

System DescriptionThe Spaulding webECG Diagnostic ECG management solution is a 12-lead diagnostic electrocardiograph along with voice signal recorder capable of acquiring, storing and transmitting ECG and voice signal data.

This solution includes the following components:

■ Spaulding Electrocardiograph Kit

■ Spaulding 12-lead ECG Patient Cable

■ USB Cable

■ Clinical Reference guide - download

■ Mason Protocol application for the display device, including Installation and Start Up Instructions

■ Spaulding webECG server application


System Information

Spaulding Electrocardiograph

1

2

1. LED Status Window

2. Main Function Button

Top View

53 4

3. Microphone

4. ECG Cable Port

5. USB Cable Port

Side View


System Information

6 5

6. USB Cable

Display Device Connections 4

7

7. Spaulding 12-lead ECG Patient Cable

Electrode Connection


System Information

LED Status Window Indicators

Display Code Meaning Definition

E EMPTY Electrocardiograph does not contain voice or ECG data and is ready to record ECG along with voice data.

RECORDING VOICE Electrocardiograph is currently acquiring voice data.

ONE HORIzONTAL BAR

ECG signal quality is poor. ECG Data that will be collected by the electrocardiograph may not provide sufficient data for analysis purposes. It is recommended that the patient be prepped and new electrodes be applied.

TWO HORIzONTAL BARS

ECG signal quality is marginal. ECG Data that will be collected by the electrocardiograph may provide sufficient data for analysis purposes. Check the quality of the ECG data after upload. It is recommended that the patient be prepped and new electrodes be applied.

THREE HORIzONTAL BARS

ECG signal quality is excellent. ECG Data that will be collected by the electrocardiograph is sufficient for data analysis purposes.

A ACQUIRING ECG DATA

Electrocardiograph is currently acquiring ECG data.

F FULLElectrocardiograph contains ECG along with voice signature data. The FULL electrocardiograph must be downloaded to the display device in order to be emptied/readied for a new data acquisition.

ERASE INDICATORVoice signature and ECG data have been transferred to the display device and the electrocardiograph is deleting the data from internal memory.

C CHARGINGElectrocardiograph is charging. The letter “C” (CHARGING) will no longer display when the battery is fully charged.

LOW BATTERY

Electrocardiograph battery capacity is too low to begin voice or ECG data acquisition.

Follow the instructions in the Charging the Battery via Display Device section to re-charge the internal battery.

U UPLOAD MODE Electrocardiograph firmware is being updated by the Mason Protocol.

Blinking

EXCEEDED VOICE DATA LENGTH

Length of voice recording has exceeded 30 seconds. Electrocardiograph is no longer recording voice data. No user action required.


System Information

Intentionally left blank

17Equipment Preparation

Equipment Preparation

Equipment PreparationThis section is intended to provide the user with information about:

■ LED Status Window on the Spaulding Electrocardiograph

■ Charging the Battery via display device

LED Status WindowThe Spaulding Electrocardiograph uses a LED Status Window to communicate unique status indicators to the user. The meaning and definition of each display code is provided in the table that appears on the previous page.

NOTE: When the electrocardiograph is paired to a display device, the display device displays the status message.

Charging the Battery via Display Device1. Connect the mini end of the USB Cable to the USB Cable Port on the Spaulding Electrocardiograph.

2. Connect the larger end of the USB Cable to the USB Cable Port on the display device.

3. Ensure the USB Cable connecting the electrocardiograph and the display device is securely connected.

4. Ensure the display device is powered on.

5. Allow the electrocardiograph to charge for a minimum of 20 minutes.

NOTE: Prior to connecting the electrocardiograph to the display device for charging, inspect the USB cable for damage. Ensure the display device Power Settings are set for continuous power (disable hibernation or sleep mode on the display device).

NOTE: The letter C (CHARGING) or F (FULL) will display on the LED Status Window while the battery is charging.

NOTE: If completely depleted, the battery requires a complete charge. The charge time could exceed one hour.

6. After a minimum of 20 minutes has elapsed, disconnect the USB Cable from the USB Cable Ports on the electrocardiograph and the display device.

7. If the letter F (FULL) is displayed on the LED Status Window, follow the steps in the ECG and Voice Signal Data Transfer to Display Device section to download data from the electrocardiograph to the display device.

18 Equipment Preparation

Equipment Preparation

8. If the letter E (EMPTY) is displayed on the LED Status Window, follow the steps in the ECG and Voice Signal Data Transfer to Display Device section and begin the data collection process.

CAUTION: Use care when connecting the USB cable to the Spaulding Electrocardiograph to ensure the appropriate connection is established and that the connector pins are not damaged or bent.

19Preparing the Patient for the 12-lead ECG

Preparing the Patient for 12-lead ECG

Preparing the PatientIn order for the Spaulding Electrocardiograph to achieve the best ECG data quality, take care during patient preparation. A good minimum-impedance pathway will provide superior, noise-free waveforms. While the client may designate the style and manufacturer of the electrodes used for ECG acquisition, Spaulding Clinical Research, LLC recommends wet gel silver-silver chloride (Ag/AgCl) disposable snap-type electrodes which are available from Spaulding Clinical, reference the Supplies section of the manual.

CAUTION: Electrodes should be stored in an air-tight container. Electrodes will dry out if not stored properly which will cause loss of adhesion, loss of conductivity, and poor quality ECG data.

During electrode placement, the patient should be comfortable and completely relaxed in a supine position for a minimum of 5 minutes. To avoid the possibility of muscular tremor, protect the patient from drafts or any other conditions that might cause chills or discomfort.

The patient should also be out of the range of sources of other equipment interference. Equipment interference can be caused by AC power devices or devices which produce high frequency interference such as: portable electronic equipment, microwaves, and x-ray equipment. Interference can also be caused by the patient moving or talking.

Preparing Patient Skin for ECG HookupIt is important to perform skin preparation before attaching electrodes to help ensure good signal quality when acquiring patient data. Poor skin-electrode contact may cause noise or artifact, which can affect the quality and analysis of the ECG data. Low amplitude signals may also be the result of poor skin-electrode contact.To prepare the skin:

1. Identify the electrode sites by referring to the Electrode Placement section.

2. Using a razor, remove any hair from the electrode sites.

3. Wipe oils from the electrode sites with an alcohol prep pad or warm soapy water.

4. Dry the skin with gauze or a clean, dry towel.

NOTE: With elderly or frail patients, take care to not abrade the skin causing discomfort or bruising. Clinical discretion should always be used in patient preparation.

Electrode Location PreparationFollow these suggested guidelines when placing the electrodes on the patient:

■ Verify that electrodes are within the expiration date. Do not use any disposable supplies that are beyond their expiration date.

■ Expose the upper arms, torso and upper thighs of the patient to attach the patient cable/electrodes.

■ Clean the electrode sites per skin preparation as discussed above.

■ Attach the electrode to the snap end of the leadwires one at a time before applying the electrodes to the patient.

■ Place the electrodes on patient using the diagrams and instructions on the following pages.

■ For large-breasted patients, placing an electrode on top of the breast may impede the reading and should be avoided if possible. It may be necessary to lift the breast and place the electrode underneath in the correct position. Undergarments, such as a bra, must be removed as they can impede readings.

■ If a limb site is not available, place the electrodes at an equal distance from the torso, and at an equal distance on the area of the stump.

■ Verify proper adhesions of electrodes. If the electrode does not move, it is properly adhered. If the electrode moves, it will need to be replaced.


20 Preparing the Patient for the 12-lead ECG

Electrode Placement

AHA Lead PlacementWhen placing chest leads on the patient, the Angle of Louis is an important biological landmark for determining lead placement. In medical terms, the Angle of Louis is the angle from an articulation of the manubrium and sternum (sternal angle). Use the illustration below as a reference for placement of the precordial (chest/torso) leads. Tactile conformation of this landmark is the first protrusion below the sternal notch, lateral to the second rib which is directly above the second intercostal space.

V1 V2

V3

V4 V5 V6

AHA

Angle of Louis

RA LA

RL LL

AHA Lead Placement

RA White Right Arm Place the electrode on the inside of the right arm on the fleshy part of the arm between the shoulder and elbow

LA Black Left Arm Place the electrode on the inside of the left arm on the fleshy part of the arm between the shoulder and elbow

RL Green Right Leg Place the electrode slightly on the inside of the right thigh on the fleshy part of the leg between the hip and knee

LL Red Left Leg Place the electrode slightly on the inside of the left thigh on the fleshy part of the leg between the hip and knee

V1 Red Fourth intercostal space to the right of the sternum

V2 Yellow Fourth intercostal space to the left of the sternum

V3 Green Directly between leads V2 and V4

V4 Blue Fifth intercostal space at the midclavicular line

V5 Orange Horizontal with V4 at left anterior axillary line

V6 Purple Horizontal with V5 at midaxillary line

21Preparing the Patient for the 12-lead ECG


IEC Lead Placement

C1 C2

C3

IEC

C4 C5 C6

Angle of Louis

R L

FN

IEC Lead Placement

R Red Right Arm Place the electrode on the inside of the right arm on the fleshy part of the arm between the shoulder and elbow

L Yellow Left Arm Place the electrode on the inside of the left arm on the fleshy part of the arm between the shoulder and elbow

N Black Right Leg Place the electrode slightly on the inside of the right thigh on the fleshy part of the leg between the hip and knee

F Green Left Leg Place the electrode slightly on the inside of the left thigh on the fleshy part of the leg between the hip and knee

C1 Red Fourth intercostal space to the right of the sternum

C2 Yellow Fourth intercostal space to the left of the sternum

C3 Green Directly between leads V2 and V4

C4 Brown Fifth intercostal space at the midclavicular line

C5 Black Horizontal with V4 at left anterior axillary line

C6 Violet Horizontal with V5 at midaxillary line


22 Preparing the Patient for the 12-lead ECG

Leadwire Color IdentificationEach leadwire is identified by color and name. If the user is located in the United States, refer to the AHA standard lead colors provided on the left side of the table below. If the user is located outside of the United States, refer to the international IEC column, provided on the right side of the table below.

AHA IEC

V1 Red Red C1

V2 Yellow Yellow C2

V3 Green Green C3

V4 Blue Brown C4

V5 Orange Black C5

V6 Purple Violet C6

LA Black Yellow L

RA White Red R

LL Red Green F

RL Green Black N

23Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG with Physician OrdersNOTE: Screen examples are for representation purposes only.

Data Collection and Transfer Using a Physicians OrderThe typical healthcare workflow for a diagnostic 12-lead ECG exam starts with a physicians order, refer to page 30 for information on entering an order.

NOTE: For Clinical Research applications refer to the workflow entitled: Acquiring a 12-lead ECG with Voice Biometrics.

Data CollectionThis section describes the steps required to acquire ECG data from the patient.

1. Press the Main Function button on the Spaulding Electrocardiograph one time to verify the letter E (EMPTY) appears on the electrocardiograph’s LED Status Window.

NOTE: If the letter F (FULL) is displayed on the LED Status Window of the electrocardiograph, follow the instructions in ECG and Voice Signal Data Transfer to Display Device section to upload data from the electrocardiograph to the display device.

NOTE: If the letter (LOW BATTERY) is displayed on the LED Status Window of the electrocardiograph, or the electrocardiograph does not respond, follow the instructions in the Charging the Battery via Display Device section.

2. Prepare the patient and attach the ECG cable/electrodes as described in Patient Preparation section.

NOTE: Excessive patient movement could interfere with the operation of the Spaulding Electrocardiograph ECG data collection. Ask the patient to remain still during the ECG data collection period and eliminate additional background noise during the voice recording.

3. Attach the 12-lead ECG Patient Cable to the ECG Cable Port on electrocardiograph as described in the System Information section on page 13.

4. Press and hold button until displayed and release immediately.

5. Press and hold the Main Function button on the electrocardiograph until displayed and release immediately.

6. Next verify lead quality, assure three horizontal bars are displayed on the Spaulding Electrocardiograph’s LED Status Window (or that no lead fail messages are displayed on the display device.

Acquiring a 12-lead ECG with Physician Orders

24 Acquiring a 12-lead ECG with Physician Orders


ONE HORIzONTAL BAR


TWO HORIzONTAL BARS




7. Press and release the Main Function button to display the letter A (ACQUIRING ECG DATA) in the LED Status Window the electrocardiograph records the data for up to 5 minutes. Press and release the Main Function button to display the letter F (FULL) to stop the recording.

8. Disconnect the patient cable from the Spaulding Electrocardiograph. Ask the patient, to remain connected to the patient cable and electrodes until verification that a good quality ECG is uploaded to the display device.



ECG Data Transfer to Display DeviceThis section describes the steps required to transfer ECG data from the Spaulding Electrocardiograph to the display device.

WARNING: To avoid the potential of compromising patient privacy, use appropriate password security measures, avoid sharing User Credentials, logout of applications after use, and use automated logout security features.

1. Launch the display device application.

2. Connect the larger end of the USB Cable to the USB Cable Port on the display device. Connect the small end of the USB cable to the electrocardiograph, see illustrations below.



3. Double click the Spaulding Client App icon to launch the Mason Workflow Protocol.

4. In the Login window, log into the Spaulding Client App with the user credentials provided by a Spaulding Clinical Research, LLC Client Services Representative.

5. When the electrocardiograph is automatically detected by the client application, the Device Data Summary window will appear.



6. After data is uploaded from the electrocardiograph to the display device, the Select Order window will open and display the patient information window.

7. The user selects and confirms an existing order. Select the row containing the correct patient demographics and double click with the mouse or keypad. The Selection Confirmation window will open. Click Yes to confirm or click No to select a different patient.

Note: If the patient is not displayed in the order list, select Add Order button and enter the patient demographic information.

8. Select the appropriate patient visit type from the drop down menu.

9. The transfer of ECG data will automatically occur between the display device and the webECG management solution.



10. When the data has completely transferred from the display device to the Spaulding webECG server, the Download ECG window will open. At this point, a PDF file containing an unconfirmed ECG report is available for viewing. The user may manually open the file by clicking the Download ECG link.

Schmitz, Tim 19Dec2012 13:50:51 CST St. Elizabeth Clinic - CEL (Cardiac ECG Laboratory)

Patient ID: SC102Age: 48Gender: MalePhysician: Dr. Sam Smith

Vent. Rate: 80RR Interval: 750PR Interval: 156QRS Duration: 96QT Interval: 376QTcF Interval: 413

Referred By: Dr. Nathanial Meriweather

Sinus rhythmNormal ECG

Unconfirmed

I

II

III

aVR

aVL

aVF

V1

V2

V3

V4

V5

V6

II

—Hz 25mm/s 10mm/mV 4 by 2.5s + 1 rhythm leads 133158 V1.00 webECG V1.1



New OrderThis procedure sequence is not required if an order is entered in advance of the ECG test.

1. To add a new patient to the Mason Workflow Protocol, click the Add Order button in the Select Order window. The Add Order window will appear.

2. Enter patient demographics into the respective fields.

NOTE: This illustration is for reference only, the data fields are configurable on a site by site basis.

■ Enter data into the applicable fields in the Add Order window in order for the patient to be added to the client database.

■ Patient demographic data can only be edited by a site designated user (as specified in site configuration) or by a Spaulding Clinical Client Services Representative once the Add Order window is closed.

3. Click the Save Order button.

4. The transfer of ECG data will automatically occur between the display device and the Spaulding webECG server and the Visit Designation window will automatically close.

NOTE: At this point, any ECG data temporarily stored on the electrocardiograph is deleted from the electrocardiograph. The erase indicator symbol will display on the electrocardiograph LED Status Window as the data is deleted.

5. When the data has transferred from the display device to the Spaulding webECG server, the Download ECG window will open. At this point, a PDF file containing an unconfirmed ECG report is available for viewing at the display device.

6. The user may manually open the file by clicking the Download ECG link to view the unconfirmed ECG report.

7. The user also has the ability to e-mail the pdf.



View ECGThe 12-lead ECG data may be reviewed in the PDF file provided in the Download ECG Window.






Unconfirmed

I

II

III

aVR

aVL

aVF

V1

V2

V3

V4

V5

V6

II


The user can print the ECG in two landscape formats:

■ On-line Mode: 4 groups of 3 leads by 2.5 seconds and a 10 second continuous lead II strip at 25mm/sec, 10mm/mV with Patient ID.

■ Off-line Mode: 12-leads by 10 seconds, 25mm/s, 10mm/mV with Patient ID. More information on off-line mode is covered on the following page.



Off-line ModeIn the event the internet connection is lost, the displays and functionality at the viewing device is the same as in the on-line mode with the following exceptions:

■ Authorized user must select Patient Demographics from site list or select Add New Order menu to enter a patient’s demographics.

■ ECG data is uploaded from the Spaulding Electrocardiograph to the display device where it remains until the internet connection is re-established and the Spaulding Client App is launched, at which time the data will be automatically uploaded to the server.

■ ECG data review and printing are available at the display device.

1. The Loading ECG progress bar will appear with the following error message in the ECG Transmission window: ECG transmission failed, please check your internet connection. To postpone the upload attempt, click the button below.

2. Click View ECG button to review the printable 12-lead ECG for the purpose of ECG lead quality check.



3. After reviewing ECG for lead quality, select the “X” in the upper right corner of the window to close the ECG off-line viewer.

4. The message window will open requiring confirmation. Select the Yes button, the ECG data is stored to the display device until Internet connection is re-established.

NOTE: When the internet connection is re-established and the Spaulding Client Application is opened, an automatic transfer of ECG data from the display device to the Spaulding webECG server will occur.



OrdersThe majority of ECGs are scheduled based on an order for a 12-lead ECG. When the department receives the order, staff can enter the order in the Spaulding webECG server so it is immediately available when the patient arrives for the test, saving time for the patient and the clinician.

To view the orders in the system, login using user name and password to access the site.

Select View Orders from the menu options above the Patient Demographic Search Fields. An Orders table with all pending orders will be displayed.

If the patient is not in the database – select Add Order menu option to both enter the patient demographics and complete the order.



If the patient has had a prior 12-lead that is stored on the system, search for the patient using the search capability and then select the Add Order menu option associated with the patient.

The new order will be added to the list of pending orders and will be available to select when the ECG data is uploaded to the webECG using the display device application.

35Acquiring a 12-lead ECG with Voice Demographic Association

Acquiring a 12-lead ECG with Voice Demographic AssociationNOTE: Screen examples are for representation purposes only.

Data Collection and Transfer Using Voice

Recording ECG and Voice Data

Linking ECG Data to Patient Demographics utilizing the Voice Signature FeatureNOTE: Collecting a voice sample is one of several methods to associate ECG data to patient demographics and is popular in clinical research settings. Collecting a voice sample is not required when physician orders are used.

Within the Mason Workflow Protocol, voice signature data is analyzed and compared to data samples stored within a site-specific, biometric voice database. The client application uses a proprietary method of voice data analysis to compare the newly acquired voice data sample with the existing voice data samples stored in the application, and then displays the best “match”, allowing the users to link ECG data with existing demographic information.

Voice Signature DataThis section describes the steps required to acquire voice signature and ECG data from the patient.

1. Press the Main Function button on the Spaulding Electrocardiograph one time to verify the letter E (EMPTY) appears on the electrocardiograph’s LED Status Window.

NOTE: If the letter F (FULL) is displayed on the LED Status Window on the Spaulding Electrocardiograph, follow the instructions in Signal and ECG Data Transfer to Computing Device section to download data from the electrocardiograph to the Computing Device.

NOTE: If the letter (LOW BATTERY) is displayed on the LED Status Window on the Spaulding Electrocardiograph, or the electrocardiograph does not respond, follow the instructions in the Charging the Internal Battery section.

2. Position the patient in a supine position in preparation for ECG acquisition.

3. Attach the ECG electrodes to the ECG leadwires as instructed in Patient Preparation section.

4. Mark the electrode locations on the patient, then apply the ECG electrodes to the patient as described in the Patient Preparation section.

CAUTION: Excessive patient movement could interfere with the operation of the Spaulding Electrocardiograph ECG data collection. Ask the patient to remain still during the ECG data collection period and eliminate additional background noise during the voice recording.

5. Attach the Patient Cable to the ECG Cable Port on Spaulding Electrocardiograph as described in the Connecting the Patient Cable to the Spaulding Electrocardiograph section.

6. Position the Spaulding Electrocardiograph, with the microphone for voice detection, between 8-12 inches from the patient’s face.

36 Acquiring a 12-lead ECG with Voice Demographic Association


7. Press the Main Function button on the Spaulding Electrocardiograph one time to verify the letter E (EMPTY) appears, then press and hold the

button on the electrocardiograph while the patient reads the script. The letter (RECORDING VOICE) will display in the LED Status Window while the electrocardiograph records the voice data.

NOTE: The electrocardiograph will record up to 30 seconds of voice data during the voice signature data recording process. The patient must record a minimum of 10 seconds of voice data for the voice sample data analysis to occur.

NOTE: If the letter (EXCEEDED VOICE DATA LENGTH) displayed in the LED Status Window begins to blink, the data recording has exceeded 30 seconds in length. This means the electrocardiograph has collected a sufficient amount of voice data required for voice signature data analysis.

Voice Recording Example Script

1. During voice signature data recording, reduce background noise and ensure no one is speaking except the patient. Instruct the patient to slowly and clearly read a script similar to the Voice Recording Example Script shown.

NOTE: The information captured in the voice data recording can be study- or protocol-specific and the voice recording script is subject to change.

My name is: ______________My initials are: ___________ My date of birth is: _______ My gender is: _____________The Sponsor of this study is: ______________________

The Protocol number is:______The Visit Identifier is: _______I am participating in a research study. My voice is being recorded for the study identification.

2. When the patient has finished reading the script, release the Main Function button. Move immediately to the ECG data collection process.

NOTE: ECG data collection must begin on the Spaulding Electrocardiograph within 4 minutes of acquiring voice signature data. If a time period greater than 4 minutes has elapsed between ECG and (optional) voice data collection, the electrocardiograph will automatically delete the patient’s voice data and the voice signature data acquisition process must be repeated.



ECG Data1. Verify the patient is connected to the Spaulding Electrocardiograph and voice data has been recorded.

2. With the patient in a supine position, instruct the patient to remain still for up to a 5 minute session of ECG data recording.

NOTE: A minimum of 1 minute of ECG data collection is recommended for data analysis.

3. To verify lead quality, assure are displayed on the Spaulding Electrocardiograph’s LED Status Window.

ONE HORIzONTAL BAR


TWO HORIzONTAL BARS




4. Press and release the Main Function button to display the letter A (ACQUIRING ECG DATA) in the LED Status Window the electrocardiograph records the data for up to 5 minutes. Press and release the Main Function button to display the letter F (FULL) to stop the recording.

5. Disconnect the patient cable from the Spaulding Electrocardiograph. Ask the patient, to remain connected to the patient cable and electrodes until verification of a good quality ECG is downloaded to the display device.

Re-Record Voice Signature DataIf a voice data recording is of poor quality, or is <10 seconds, the operator has the ability to delete it and re-record a new voice sample. Voice signature data re-recording must be accomplished before the ECG data collection process begins.

1. To erase voice data from the electrocardiograph, press and hold the Main Function button on the electrocardiograph for approximately 2 seconds.

NOTE: The Erase Indicator will appear on the LED Status Window while the voice data is erased from the Spaulding Electrocardiograph.

2. Verify the letter E (EMPTY) re-appears on the LED Status Window.

3. Follow the steps in the Recording ECG and Voice Data section and repeat the voice signature data recording process.

When voice data is successfully recorded move on to collecting ECG Data.



ECG and Voice Signal Data Transfer to Display DeviceThis section describes the steps required to transfer ECG data and voice data from the Spaulding Electrocardiograph to the display device.

WARNING: To avoid the potential of compromising patient privacy, use appropriate password security measures, avoid sharing User Credentials, logout of applications after use, and use automated logout security features.

1. Log into the display device.

2. Connect the larger end of the USB Cable to the USB Cable Port on the display device. Connect the small end of the USB cable to the electrocardiograph, see illustrations below.



New Patient EnrollmentNOTE: If a patient’s voice data sample was not previously uploaded to the client database, a voice match cannot occur within the Mason Workflow Protocol.

1. To add a new patient/subject to the Spaulding Client App, click the Add New Patient button in the Assign Demographics window. The Add Patient (Subject) window will appear.

2. Enter patient demographics into the respective fields.

NOTE: This illustration is for reference only, the data fields are configurable on a site by site basis.

■ Enter data into the applicable fields in the Add Patient (Subject) window in order for the patient to be added to the patient database.

■ Patient demographic data can only be edited by a site designated user (as specified in site configuration) or by a Spaulding Clinical Client Services Representative once the Add Patient (Subject) window is closed.

■ The Spaulding Client App is used to upload ECGs from the Spaulding Electrocardiograph to the Spaulding webECG Server. The Select Order screen allows the user to associate the collected ECG data with either an existing ECG Order, or, a new ECG Order. To associate the ECG data with an existing order, double-click the appropriate row in the ECG order table of the Select Order menu. If your patient is not in this list, you will need to add a new ECG Order. To add a new ECG Order select the Add New Order button at the bottom of the menu. The Add New Order function is used when a patient’s ECG Order was not entered prior to the ECG being uploaded. There are two potential reasons why there would not be an existing order in the Select Order menu of the Spaulding Client App:

a. An order has not been entered into, or received by, the system; or,

b. An order is present in the system, but the Client App is working in offline mode and does not have access to the existing order.

■ The Add New Order menu of the Spaulding Client App requires the user to manually enter patient demographics. If the entered demographics include a Patient ID which is a duplicate of a Patient ID already in the Spaulding webECG DB, the new ECG data will be added to the previously existing Patient ID/demographics, even if there is a discrepancy in the other demographic information entered at the Client App.

NOTE: If at any time edits are required to a patient demographic record, those edits are be made using the Spaulding webECG user interface.



3. Click the Save Patient button. The Visit Confirmation window will appear.

4. Select the appropriate visit identifier from the drop down menu.

NOTE: By default, the Spaulding Client App numerically and incrementally increases the site visit number for each visit (Visit 1, Visit 2, and so on).

5. Click the Associate Visit button.

6. The transfer of ECG and voice data will automatically occur between the display device and the Spaulding webECG server and the Visit Designation window will automatically close.

NOTE: Any voice signature and ECG data temporarily stored on the electrocardiograph is deleted from the electrocardiograph. The erase indicator symbol will display on the electrocardiograph LED Status Window as the data is deleted.

7. When the data has transferred from the display device to the Spaulding webECG server, the Download ECG window will open. At this point, a PDF file containing an unconfirmed ECG report is available for viewing at the display device.

8. The user may manually open the file by clicking the Download ECG link to view the unconfirmed ECG report.



Existing Patient Process1. Double click the Spaulding Client App icon to launch/open the Mason Workflow Protocol.

2. In the Login window, log into the Spaulding Client App with the user credentials provided by a Spaulding Clinical Research, LLC Client Services Representative.

NOTE: A separate login to the client application can be enabled/disabled in site configuration.

The user can: perform an automated search (using voice biometrics), perform a manual search, confirm an existing patient in the database, or enter a new patient. The system will not accept a New Patient record if entered data (in all required fields) is a duplicate of an existing patient record at that site. In that case, user will be returned to the Patient Demographics screen.

3. When the electrocardiograph is automatically detected by the software application, the Device Data Summary window will appear.

4. Progress bars will show the status of voice signature

and ECG data transfer from the electrocardiograph to the display device. When both progress bars have reached 100%, the Device Data Summary window will close and the Assign Demographics window will appear.



5. After data is uploaded from the electrocardiograph to the display device, the Assign Demographics window will open and display the patient demographic information window.

NOTE: Patient match is listed in descending order in the Assign Demographics window, with the highest probable match at the top of the list.

NOTE: review the voice data by clicking the Play Voice button if audio verification is necessary.

6. The user selects and confirms an existing patient from the database (continued below) or enters demographic information for a New Patient.

7. Select the row containing the correct patient demographics and double click with the mouse or keypad. The Selection Confirmation window will open.

8. Click Yes button to confirm or click No button to select a different patient.

9. The Visit Confirmation window will appear.

10. Select the appropriate patient visit type from the drop down menu.

NOTE: By default, the Spaulding Client App numerically and incrementally increases the site visit number for each visit (Visit 1, Visit 2, and so on).

NOTE: An unscheduled visit may also be assigned by selecting “unscheduled” from the list.

11. Click the Associate Visit button.

12. The transfer of ECG data will automatically occur between the display device and the Spaulding webECG server.

NOTE: At this point, voice signature and ECG data stored on the Spaulding Electrocardiograph is deleted from the electrocardiograph. The erase indicator symbol will display on the electrocardiograph LED display as the data is deleted.



13. When the data has completely transferred from the display device to the Spaulding webECG, the Download ECG window will open. At this point, a PDF file containing an unconfirmed ECG report is available for viewing. The user may manually open the file by clicking the Download ECG link.






Unconfirmed

I

II

III

aVR

aVL

aVF

V1

V2

V3

V4

V5

V6

II




View ECGThe 12-lead ECG data may be reviewed in the PDF file provided in the Download ECG Window.






Unconfirmed

I

II

III

aVR

aVL

aVF

V1

V2

V3

V4

V5

V6

II


The user can print the ECG in two landscape formats:

■ On-line Mode: 4 groups of 3 leads by 2.5 seconds and a 10 second continuous lead II strip at 25mm/sec, 10mm/mV with Patient ID

■ Off-line Mode: 12-leads by 10 seconds, 25mm/s, 10mm/mV with Patient ID. More information on off-line mode is covered on the following page.



Off-line ModeIn the event the internet connection is lost, the displays and functionality at the viewing device is the same as in the on-line mode with the following exceptions:

■ Authorized user must select Patient Demographics from site list or select Add New Order menu to enter a patient’s demographics.

■ ECG data is uploaded from the Spaulding Electrocardiograph to the display device where it remains until the internet connection is re-established and the Spaulding Client App is launched, at which time the data will be automatically uploaded to the server.

■ ECG data review and printing are available at the display device.

1. The Loading ECG progress bar will appear with the following error message in the ECG Transmission window: ECG transmission failed, please check your internet connection. To postpone the upload attempt, click the button below.

2. Click View ECG button to review the printable 12-lead ECG for the purpose of ECG lead quality check.



3. After reviewing/printing the ECG, select the “X” in the upper right corner of the window to close the ECG off-line viewer.

4. The message window will open requiring confirmation. Select the Yes button, the ECG data is stored to the display device until Internet connection is re-established.

NOTE: When the internet connection is re-established and the Mason Protocol is opened, an automatic transfer of ECG and voice data from the display device to the web-based server will occur.

47Review ECG Data

Review ECG DataNOTE: Screen examples are for representation purposes only.

ECG DataECG data is securely stored in the Spaulding webECG server that can be accessed via a site specific URL secured internet address. Access requires the user to login with their user name and password. All user levels can access the stored patient information but only site or organizational administrators can modify the demographics for a stored ECG.

NOTE: Healthcare agency/organization users that access the webECG system expected to be trained and signed off on HIPPA compliance before gaining access into the system.

Review Patient RecordTo find a patient record in the database, use the system search capability and enter any element of the patient demographic information to locate the record. Based on the search criteria the user may be presented with more than one patient, select the correct patient from the list to view the stored patient records.

1. Enter demographic data into the search field(s): a list of patients in the database matching the search criteria are displayed. Select the patient to review from the list.

NOTE: This is not applicable to the Clinical Research configuration.

2. Select the patient by clicking on their Patient ID hyperlink to view the stored patient records.

Review ECG Data

48 Review ECG Data


Review 12-lead ECG ReportThe patients records are displayed with the newest exam first. Select the PDF icon under the 12-lead ECG to display the stored 12-lead report in a PDF format






Unconfirmed

I

II

III

aVR

aVL

aVF

V1

V2

V3

V4

V5

V6

II


49Review ECG Data


To view the comparison ECGs select the Magnifying Glass icon on the stored patient record to bring up Comparison ECG menu option to choose which ECG to compare.

NOTE: Side by side comparisons are not available for the Clinical Research configuration.

50 Review ECG Data


Review Full Disclosure WaveformsSelecting the magnifying glass under the Full Disclosure column will display the full disclosure data that was stored as part of the 12-lead ECG collection. Up to 5 minutes of ECG data is available for review based on the length of time collected. When viewing data the user can modify the waveform speed, gain and number of waveforms and then use the scroll bars to move through the waveform data.

51Review ECG Data


webECG Report

Review webECG ReportSelect the PDF icon under the webECG Report column to display a comprehensive report that goes beyond the measurements that are typical for a 12-lead ECG. To receive value from this report, data should be collected for over 2 minutes.

ECG Examination Report V2.0 Ref 101 -1 of 4

Physician Evaluation / CommentsUnconfirmed ECG Recording

Interval Values, mSec or bpmAve Min Max SD Normal Range

PR 171 169 172 0.80 110-219 msQRS 75 73 77 0.90 70-109 msQT 356 355 358 0.80 325-452 msQTcF 391 390 394 1.00 355-454 msQTcB 411 409 413 1.10 360-462 msRR 750 750 750 0.00 612-1250 msHR 80 80 80 0.00 45-99 bpm

Beat DataRecording Duration: 273.10 secExtractions Analyzed: 27Number of Beats: 364Predominant Rhythm: SinusN Noise Rejection: 2N Beat Class Rejection: 0

ECG DetailsRecording Date /Time: 19Dec2012 13:50:51 CST

ECG RecordingDuration: 273.10 sec

ECG Status: UNCONFIRMEDDeviceInformation:

Spaulding IQ BV:3 FV:1.00 HV:2SN:9-11-46-0063-101 DV: 133158

Diagnostic Statements and Information27/27 - Sinus rhythm27/27 - Normal ECG

St. Elizabeth Clinic (Cardiac ECG Laboratory)Address: 1234 Main, West Bend

WI, United States Tel: 999-999-9999 Email: [email protected]

Opening Hours: Mon-Fri 9am-5pm

Spaulding webECG Report

Patient InformationPatient ID: SC102 Surname: Schmitz First Name: Tim

Gender: Male Date of Birth: 15Feb1964 Physician: Dr. Sam Smith

52 Review ECG Data



Signal Averaged ECGValue Normal Range

LAS40 26.00 < 38 msQRS 92.00 < 115 msRMS40 63.20 > 20 uVTarget Noise Level < 0.4uV

Two out of three values out of range should be considered anabnormality

T-Wave MorphologyInterval Ave Min Max SDGMFA1 301 298 306 1.80GMFA2 300 298 305 1.70GMFS1 38 38 38 0.20GMFS2 33 32 33 0.10GMFU 285 284 287 0.70

QT VariabilityVariable Value UnitQTPeakVI 1.27 msQTPeakVM 0.00 msQTPeakM 279.60 msQTPeakV 207.12 msQTVI 1.10 msQTVM 0.00 msQTcBs 411.35 msQTcFs 392.15 msQTm 356.40 msQTv 228.92 msRRm 750.67 msRRv 80.22 ms

Heart Rate VariabilityStatistic Value UnitRRMean 750.67 msRRSD 0.47 msRMSSD 0.81 msFrequency Value UnitLF 0.00 ms2

LFnu 0.65 %HF 0.01 ms2

HFnu 6.32 %LF/HF 0.10 n




53Review ECG Data






1 Summary ECG

54 Review ECG Data






2 Selected ECG

55Physician Tool Kit

Physician Tool KitNOTE: Screen examples are for representation purposes only.

Over-read of the 12-lead ECG using the Spaulding Physician Tool Kit, web-based application

Physician or other clinical user will access the Spaulding Clinical Physician Tool Kit via a secured internet connection from a Spaulding Electrocardiograph application that is downloaded onto the Physician’s display device and use the tools provided with secure login credentials to provide the ECG over-reads and electronically sign the report.

A list of ECGs to be read appears with the total count of unread ECGs in the title bar. Double click the first (or any) ECG in the list to upload images for reading.

■ The physicians “Work List” appears upon login, sorted by the oldest-to-newest ECGs to be read.

■ If there are any ECGs flagged as “Priority” based on serial comparison, evaluation, diagnostic statements or for any other reason, the “Priority” ECGs will appear in red at the top of the list (above the oldest-to-newest ECG list).

■ The physician shall have access to view all of the saved ECG data (up to 5 minutes), the median complexes, or the 12-lead ECG (the 10 second strip that the Mason Protocol selected for over-read).

The uploaded ECG information appears initially in three windows.

One window shows the full 12-lead ECG, another shows the instruction and interpretation dialog and the third behind the other two) shows the protocol-specified beat for measurement, in this case the lead 2 median beat.

Physician Tool Kit

56 Physician Tool Kit


ECG Over-Read Process

Step 1: Examine the 12-lead ECG ■ If the ECG is readable, proceed to the next step

■ If it is not readable, reject it using the Reject button followed by Update button

■ Usual causes for unreadability are:

» Excessive noise or artifact

» Lead placement errors that cannot be “read around”

» Waveforms that defy accurate measurement

Task Bar Icon Definitions

Open digital display dialog Heart rate

Instant global view Semiautomatic

Filter Finalize tangent

Up arrow Click and choose

Down arrow Show Result

Superimposition tool Freeze annotations

Representative (median) beat Restore annotations

Create representative (median) beat About



Step 2: Measure Intervals ■ Click on the CalECG window showing the median beat at high resolution to bring it to the foreground

■ Select Show Results button to view real-time interval values. Adjust the calipers by right-clicking and holding the small box on the bottom of the annotation bar and dragging the cursor to the correct measurement location.

■ Manually adjusted (caliper) measurements will be automatically updated to reflect the caliper placement. Notice if any of the new interval values are abnormal.

■ Click the interpretation dialog window or its task bar icon to bring it to the forefront.



■ The physician has the ability to edit or add to the unconfirmed interpretation and these changes will be reflected on the over-read report.

■ Revise the automated interpretation in the middle window according to the instructions on the left. The user may be prompted to add specific statements required by the sponsor if required information is missing (such as “not clinically significant”).

■ The physician shall electronically sign the ECG report, and click the Update button, which moves the 12-lead ECG off of the “To Do” list and on to the “Completed Work” list.

■ The physician has access to their “Completed Work List.” This list is sortable by Date, Last Name, and Patient ID.

■ The physician is able to view prior ECGs for that patient (access to 12-lead ECG records residing in the Spaulding Clinical ECG server) while reviewing a new ECG.

NOTE: Prior to clicking the Update button, the user may choose to use the following features to provide a more detailed analysis:

» Perform Comparison

» Interpret the Full Report

» Assess Arrhythmia



Perform Comparison ■ If the current ECG requires comparison to a previous ECG, the Interpretation window will show an

active Comparison ECG button, and the interpretation section of the window will include the initial comparison statement.

■ Both ECGs are displayed side by side (or overlapping if the screen is small) after clicking the Comparison ECG button.

■ Move the ECGs around as needed to see all of both reports.

■ To look at the comparison ECG in high resolution, click the View In CalECG button at the bottom of the ECG.

■ To see any lead in greater detail, click the CalECG interval annotation window behind the current ECG to examine each lead using the Arrow buttons in the upper left task bar.



Interpret the Full ReportThe full ECG report includes one to several 10-second ECGs, eight tables with a variety of data and an interpretation section.

■ Click the Full Report tab. This will display an empty interpretation box on the left and the tables of the full report on the right.

■ A template containing verbiage for the interpretation can be entered into the interpretation box by clicking the Load Default Interpretation button. The wording can then be changed as needed to interpret the current report. Alternatively, the user can enter the interpretation from scratch.

■ Though the physician is free to interpret the tables of the full report according to his/her knowledge and preference, the following criteria and wording are currently recommended.

» Beat Data Table – This table summarizes the data used to create the summary ECG and used for analyses in the subsequent tables. No interpretive statement is needed for this table.

» Interval Values Table – This table provides summary statistics of the interval measurements of all eligible beats. The first line of the default interpretation, “The summary ECG is representative of the full recording,” indicates that the mean values in the table are reasonably similar to the annotation values of the summary ECG. To date, no instances of marked differences between the summary ECG values and the table values have been encountered, though this certainly could happen, as the table is based on automated algorithmic measurements while the summary ECG is based on annotations performed in CalECG. The third line in the default interpretation gives an indication of how broad the ranges of interval values in the table are. The primary reason for a broad range is noise. In general, the variability in the table is normal when the range of QRS values is ≤ 10 msec, and “consistent with modest noise” when > 10 msec.

» Diagnostic Statements Table – This table provides a tally of all diagnoses made by the Glasgow diagnostic algorithm. If there is a full 5-minute recording, the algorithm will generate diagnoses for each consecutive 10 seconds of ECG data. A typical list in an ECG with some noise (or with true variability in waveforms) might show a pattern like this:

30/30 – Sinus rhythm 30/30 – rSr’(V1) - probable normal variant 1/30 – ST junctional depression is nonspecific 1/30 – Borderline ECG 29/30 – Normal ECG

While a completely clean recording would look like this:30/30 – Sinus rhythm 30/30 – Normal ECG

Since this table can be expected to vary in length and variety of diagnoses as a result of recording noise, we are currently using the statement “The summary of algorithmic diagnostic statements is unremarkable” on all reports.

The most important function of the diagnostic list is to trigger review of the full recording when PACs and PVCs are detected by the Glasgow algorithm.



» Heart Rate Variability –Time Domain Table – Only three HRV values are used in the time domain due to the shortness of the recording. RRMean is simply an indication of the average RR interval. When the average RR is low (less than 700 msec) one often sees low HRV. If that is the case, the HRV statement (fifth line in the default interpretation) can be modified to: “Heart rate variability is low, consistent with relative tachycardia.” No further statement in the final summary of the interpretation (line 9) would be needed in this case.

The following criteria are used to declare low HRV in the time domain: RRSD < 32 ms and/or RMSSD < 19 ms. At present we are not noting high values above the usual range. If HRV is low in either the time domain or the frequency domain, low HRV is diagnosed on line five and mentioned in line 9 of the default interpretation.

» Heart Rate Variability –Frequency Domain Table – At present we examine only two of the five variables listed in the table to determine if HRV is low: HF and LF. If the sum of these two values is less than 275 ms2, then HRV is deemed to be low. There are instances in which HRV is only calculated in the time domain or in the frequency domain. In these cases we state that HRV I normal or low in that specific domain.

» QT Variability Table and T-Wave Morphology Table – At present normal ranges for these two sets are data are not known. This is stated in lines 6 and 7 of the default interpretation.

» Signal Averaged ECG Table – Criteria for normality/abnormality are stated in the table. If two of the three values are abnormal, the last word in line 8 is changed to “abnormal” and abnormal SAECG is mention in the summary statement in line 9.

» Arrhythmias Seen on the Full Recording – The full recording may be reviewed to help interpret several observations on the summary ECG, as well as to identify arrhythmias. In most of the latter cases, arrhythmia diagnosed by the Glasgow algorithm triggers this review. Findings resulting from this review are described on line 2 of the default statement. These are also mentioned in the summary statement on line 9 if abnormal. Criteria for abnormal ectopic beat frequency (either atrial, ventricular, or uncertain) during a 5-minute recording are described below. If the recording is shorter than 5 minutes, the criteria should be proportionately decreased.

• < 5 = normal

• 5 – 10 = frequent (abnormal)

• > 10 = very frequent (abnormal)



The viewer for the full recording is shown below. Browse through the recording by pressing the horizontal scroll bar arrows at the bottom of the viewer. A convenient way to quickly scan the recording in pseudo-superimposition mode is to right click and hold the horizontal scroll bar at the point indicated by the black star. PVCs are easily recognized this way and sudden changes in the rate, as happens after a premature beat, are immediately recognized by a change in the superimposition pattern.

■ Complete the summary interpretation on line 9 by leaving it unchanged if there are no abnormalities on the summary ECG or in the full report, or by mentioning specific abnormalities. A typical interpretation of a record with several abnormalities in the summary ECG and the full report might be “Abnormal summary ECG, low HRV and abnormal SAECG>” A typical summary when a single abnormality is present in the full report might be “Normal study overall except for low HRV.”



Assess Arrhythmia ■ If the current ECG requires an assessment of the ECG strips which have been marked with an arrhythmia

by the automated algorithm, the Arrhythmia button will appear on the bottom of the application window (blue arrow):

■ Clicking the Arrhythmia button pulls up a list of all arrhythmia strips for the given recording:



■ Double clicking on an ECG pulls it up for viewing:

■ The physician must write in an assessment of the ECG in the free-form text field (Reader Arrhythmia Interpretation) and determine if the ECG should be included in the final report. If so, check the Include in Analysis check box to have the current strip included in the final ECG report under the Arrhythmia tab.

■ The physician may also choose to view the current strip in the CalECG viewer by clicking the AMPS Tool button in the bottom right corner (blue arrow).

■ Only when the physician clicks the Save Interpretation button will the added interpretation be updated in the database. The physician should return to the arrhythmia list and assess the remaining arrhythmia ECGs as the study protocol requires.



AcronymsThe following acronyms will be utilized:

■ /ncs = Not Clinically Significant

■ /cs – Clinically Significant

■ /nsc = No Significant Change




67Site Configuration & Management

Site Configuration & ManagementNOTE: Screen examples are for representation purposes only.

Spaulding webECG Site Configuration and Management

This section discusses the site configuration and management tools that are available to the site administrator for the typical Healthcare user configuration.

NOTE: For Clinical Research the system is configured based on the study protocol by Spaulding Clinical Research. No changes can be made at the site level to the configuration.

Caution should be used when modifying the site configuration as it could impact notifications to physicians, the automated interpretation of the ECG, the report format for the ECG and the database. Please contact Spaulding Clinical Client Services Technical Support at 888-607-7871 or 262-306-3348 if you have any questions before making changes.

NOTE: Healthcare agency/organization users that access the webECG system are expected to be trained and signed off on HIPPA compliance before gaining access into the system.

Logging InAfter proceeding to the Spaulding webECG home page, enter provided user name and password in the field provided. Press Login button to access the Spaulding webECG server.

Creating and Managing UsersWe know that you will experience staffing changes at your facility so your site administrator has full rights to setup new users and delete staff at any time.

To modify information for a current user or delete a user from the system, select a user from the User Drop down menu

68 Site Configuration & Management


The user detail menu will be displayed to make any changes to the user profile. Be sure to SAVE any changes completed for each user.

To Add a new user – Select the Configure New User menu option and enter the fields to add a new user and Save.

The site administer can export the list of system users by accessing the Export menu option. User information is placed in an excel file that can be stored remotely for reference.



Site ConfigurationThe site administer can customize the following information for their specific unit. Select the Edit Site menu option from the Site Overview menu. There are several sections to the site configuration. Remember to scroll all the way to the bottom of the page to select the Update menu option to save any changes.

Site Specific Settings Options include:

■ Name of the department.

■ Email notifications including subject line and addresses for unconfirmed and confirmed email recipients.

Site Software SettingsCustomize the language, time zone, and login time out along with site specific help resources for the system. The user may wish to continue to identify Spaulding Clinical’s Technical Support information as a resource here rather than your facilities IT help desk based on your organization policy.



Biometrics SettingsAll settings in this configuration section are related to the use of voice biometrics for patient identification. If the user is not using Voice these should not be checked.

Email SetupThis section provides the subject line that is used when system users are provided their system user name and password to access the system. The user can customize this message based on internal IT policies.

ECG Report ConfigurationThis section provides the ability to configure the 12-lead ECG format.

1. Select the waveform layout from one of the following:

■ 3 x 4

■ 6 x 2

■ 12 x 1

2. Configure location name that will appear on the header of the 12-lead ECG.

3. Select the Lead for the rhythm strip – if no rhythm strip is desired, leave the empty blank.

4. Select Offset Leads to reposition the leads baseline – this is typically only used in 12 x 1 format.

5. Select Low Pass Filter to enable the 40 Hz filter.



Advanced Settings ■ Suppress Interpretations

Checking this box will turn off the automated interpretation of the unconfirmed 12-lead ECG.

■ Power line Frequency Based on power line frequency set the filter to either 50 or 60 HZ.

■ ECG Site Reader To auto-assign all ECGs to a specific physician for over-read then identify that physician in the pull-down menu. Otherwise all ECGs are assigned individually by the physician.

Edit LocationSelect site and the site overview menu displays an option to Edit Site.

Select Edit Location menu option to change the address that appears on the webECG Report.



Editing Patient Demographics1. Select the patient from the database with the demographic error to be corrected.

2. Select Patient Overview menu option in the header bar with the patient demographics displayed.

The demographics will be displayed with any unassigned field available to be updated. To modify a field that already contains data, Select the Edit Patient menu option.

Fields will then be unlocked to make modifications.

If the change will apply to all records for the patient, select the Apply to All box.

For Clinical Research studies the physician assignment can be modified via this process. Whenever demographics are modified on a record the reason for the change is required documentation. Select the UPDATE menu to complete.



Demographic Management:Select Demographic Management menu option from the Edit Site menu:

The Demographic Configuration table will be displayed with the current demographic configuration.

CAUTION: All demographic setup changes, except the “Collection Options” column impact the existing database so use caution when making modifications. Please contact Spaulding Clinical Client Services Technical Support at 888-607-7871 or 262-306-3348 with any questions as changes impact the entire database for your organization.

Reordering Demographic Fields:Click and hold to move a demographic entry in the list



Adding Demographic FieldsTo add a new Demographic field select the Add Demographic menu option. A new menu will be presented with all the items required to setup a new demographic field in the database. Fields that are identified as Patient in the Relation column will be searchable in the Site Overview menu. All other entries, even when searchable is selected, will not appear in the Site Overview menu. When the user has completed the menu form, select Save button to return to the demographic configuration table.

Enter the appropriate information based on the type of demographic information needed. Use the currently configured demographic as a guide.

Deleting Demographic FieldsUse the to delete a field that the user site will not be using.

75Supplies

Supplies

Spaulding Electrocardiograph Supplies

Description Part Numbers

Spaulding Electrocardiograph KitKT-1020973 KT-1020973

AHA IEC

Spaulding 12-lead ECG Patient Cable WR0462CS WR0463CS

AHA IEC

USB Cable WR0457CS

Spaulding ECG Electrodes, Bulk Pack of 60 Disposable snap-type electrodes

A10026T-60*

Clinical Reference Guide 9920-101-09-eng

Spaulding Electrocardiograph Display Device Installation and Start Up Instructions

9920-101-04-eng

* Call Spaulding Client Services & Technical Support Group 1-888-607-7871 to reorder electrodes

Supplies

76 Supplies

Supplies


77Maintenance & Troubleshooting

Maintenance & Troubleshooting

General Care and Cleaning Instructions

General CareInspect equipment daily prior to operation. If you notice anything that requires repair, take the Spaulding Electrocardiograph out of service and contact Spaulding Clinical Research, LLC.

■ Verify that all cables and connectors are securely seated.

■ Check the exterior of the electrocardiograph for any visible damage.

■ Inspect the 12-lead ECG Patient Cable and connectors for any visible damage.

■ Inspect the Main Function button and LED Status Window for proper function and appearance.

■ The electrocardiograph has no serviceable parts and calibration is not required. Periodically check functionality of the electrocardiograph by performing a test ECG and Voice acquisition and observing the expected results using a non-patient visit designator (e.g. “TEST”).

Cleaning the Patient Cable and the Spaulding ElectrocardiographWARNING: Failure to follow recommended cleaning procedures, or contact with unspecified cleaning

materials/disinfecting agents could result in increased risk of harm to users, patients and bystanders, or damage to the device.

WARNING: To avoid potential for spread of disease or infection, the Spaulding Electrocardiograph, Spaulding 12-lead ECG Patient Cables, and leadwires should be cleaned before and after each use. To maintain safety and effectiveness, single-use disposable components beyond their expiration date must not be used. All electrodes and single-use cable/electrodes sets should be properly disposed of after use in accordance with applicable requirements. Single-use disposable components (e.g. electrodes, patient cables, etc.) must not be reused.

CAUTION: Do not attempt to clean the device or 12-lead ECG Patient Cables by submersing into any liquid, autoclave, or steam cleaning as this may damage the Spaulding Electrocardiograph and accessories.

Methods Remove both the USB Cable and the 12-lead ECG Patient Cable from the Spaulding Electrocardiograph before cleaning.

■ For general exterior cleaning of the electrocardiograph, the Patient Cable, and leadwires, use a dry, lint-free, soft cloth that is slightly moistened with a mild detergent and warm water solution. Wipe the equipment exterior surfaces and cables with a dry, lint-free, soft cloth and let them air dry. Do not use any excessive drying techniques, such as forced heat.

■ Do not spray any cleaning solution directly onto the electrocardiograph. Do not autoclave the 12-lead ECG Patient Cable or electrocardiograph.

■ Do not attempt to clean the device or 12-lead ECG Patient Cables by submersing into any liquid, autoclave, or steam cleaning as this may damage the electrocardiograph and accessories.

■ Never expose the electrocardiograph or 12-lead ECG Patient Cable to strong ultra violet radiation, as ultra violet radiation may degrade the plastic coating on the module or cable.

78 Maintenance & Troubleshooting


TroubleshootingThis section is intended to provide the user suggested maintenance and troubleshooting suggestions.

LED Status Window Display Code TroubleshootingBehavior or LED display code Probable Cause Resolution

Low Battery Battery is LOW Follow the steps in Charging the Battery via Display Device section of the manual.

No display Battery depleted Follow the steps in Charging the Battery via Display Device section of the manual. Repeat process until a display code appears in the LED Status Window.

FULL F Spaulding Electrocardiograph contains ECG and along with voice data. Additional data cannot be recorded.

Follow the steps in ECG and Voice Signal Data Transfer to Display Device section of the manual.

Frozen in UPLOAD MODE U

Electrocardiograph is locked in firmware upload mode.

Call Spaulding Client Services.

1 BAR ECG signal quality is poor. ■ Follow the instructions in the Patient Preparation, section of the manual.

■ Review LED status window messages in the System Information section of the manual.

■ Inspect equipment, verify the integrity of the leads, cables and verify all connections to electrodes.

2 BAR ECG signal quality is marginal.

■ Follow the instructions in the Patient Preparation, section of the manual.

■ Review LED status window messages in the System Information section of the manual.

■ Inspect equipment, verify the integrity of the leads, cables and verify all connections to electrodes.

79Maintenance & Troubleshooting


Voice Signature Data TroubleshootingBehavior Probable Cause Resolution

Biometric or Voice Signature data match cannot be established.

Poor voice quality due to: ■ No voice collected

■ Electrocardiograph too far from patient during recording

■ Patient voice recording too quiet

■ Too much background noise during recording

Follow the steps in Data Collection and Transfer using Voice section of the manual.

Voice Signature Data is erased

If the inactivity time after recording voice exceeds 4 minutes, this causes the electrocardiograph to erase.

Follow the steps in Data Collection and Transfer Using Voice section of the manual.

ECG Data TroubleshootingBehavior Probable Cause Resolution

Poor Quality ECG displayed in the pdf rendering

Poor electrode placement and/or connectivity to the patient.

ECG may contain excessive artifact interrupting further processing.

Follow the steps in Data Collection and Transfer Using Voice section of the manual and repeat the ECG collection and download process.

80 Maintenance & Troubleshooting


Troubleshooting the Display DeviceBehavior Probable Cause Resolution

Error message: “ECG transmission failed, Please check internet connection”

Loss of internet connection ■ Follow the steps in Off Line Mode section of the manual.

■ Check the internet connection. Call internal IT Support Group.

Error Message: “The uploaded ECG could not be processed”

Noisy ECG Signal as a result of dry electrodes, poor skin preparation or patient movement.

Insufficient ECG data, collected less than 1 minute recommended ECG data sample.

The most likely cause is a noisy ECG signal. To review the quality of the ECG data collected, select the Launch button to view the Full Disclosure waveforms. Repeat the 12-lead ECG.

Virus related problems

Virus on display device User should run regular virus checks on all display devices that are used with the electrocardiograph to ensure safe/effective operation.

Password Login ErrorsBehavior Probable Cause Resolution

Login error Incorrect password credentials Call Spaulding Client Services or site administrator.

81Software Installation

Software InstallationNOTE: Screen examples are for representation purposes only.

Spaulding Electrocardiograph SpecificationsElectrocardiograph Requirements

Operating Modes and Features

Device Classification Specification

Class I, type CF Defibrillation-proof applied parts IPX21 non-transit operable; portable

Instrument Type 12-lead Electrocardiograph

Input Channels 5-minute, simultaneous acquisition of all 12-leads 30-second voice signal recording

Standard Leads Acquired I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6

Storage Capacity Up to 30-seconds voice signal and 5-minutes ECG data

Operator Message Window LED Status Window

Operator Interface Controls Front panel Main Function button

A/D Conversion 12 bits (2.664 microvolt LSB)

Digital Sampling Rate 1000 s/sec/channel

Frequency Response 0.05 to 150 Hz

Special Functions Integrated Lead Quality Check, High performance baseline recovery

Power

Battery Type Internal rechargeable lithium polymer battery

Sleep Mode The Spaulding Electrocardiograph will go into a sleep mode to preserve the battery life after a period of inactivity. A completed recording (voice and ECG) is retained indefinitely in the case of a depleted battery.

Physical

Dimensions 3.5 in. diameter x 1 in. (9 cm diameter x 3 cm)

Unit Weight 3.5 ounces (100 gms)

Environmental

Operating ■ Temperature +0 to +45 °C (+32 to +113 °F)

■ Relative Humidity 10% to 95%, Non-condensing

■ Ambient Air Pressure 500 to 1060 millibars

Storage/Transport ■ Temperature –25 to +70 °C (–13 to 158 °F)

■ Relative Humidity 0% to 95%, Non-Condensing

■ Ambient Air Pressure 700 to 1060 millibars

82 Software Installation


Electrocardiograph Specifications

Patient Interface and Safety

Patient Cable/LeadwiresDetachable, unshielded, Spaulding 12-lead ECG Patient Cable with built-in defibrillator protection resistance.

Input Impedance

Meets or exceeds the requirements of ANSI/AAMI EC11

Common Mode Rejection Ratio

Electrode Offset Tolerance

Input Dynamic Range

Overload Protection

Patient Leakage Current Meets or exceeds the requirements of Class I Type CF Equipment, Standard IEC 60601-1

ANSI/AAMI ES1Chassis Leakage Current

Connectivity

Standard USB Port 1.1/2.0 Compliant Interface



Display Device and Mason Workflow Protocol Specifications

Minimum Display Device SpecificationsFeature Specifications

Laptop/Desktop Display Device

International Safety StandardsConform to international safety standards for information technology equipment (i.e. IEC 60950)

Operating System The Mason Protocol operates in a JAVA Runtime Environment and is compatible with Microsoft® Windows® XP, Windows Vista and Windows 7 operating systems.

Physician over-read tools compatible with Microsoft Windows.

Ram (Memory) 512 MB (minimum)

Processor 1 GHz 32-bit or 64-bit processor (minimum)

Computer Configurations Desktop, Laptop, Tablet, Touch pad and others based on operating system compatibility

Internet Compatibility Operating system compatible web browser

Internet Communication Secured HTTPS Internet Protocol

Video Resolution 1040 x 600 (minimum)

Disk Space 1 GB (minimum)

USB Port Connection available for acquired data upload

Network Connectivity Wired or wireless

Virus Protection Recommended

WARNING: User should run regular virus checks on all display devices that are used with the Spaulding Electrocardiograph to ensure safe/effective operation.

WARNING: Set the display device to the correct date/time prior to use with the Spaulding Electrocardiograph.



WARNING: Display device settings must accommodate local lighting conditions for readability.

NOTE: Users of the software application are recommended to have their computing environment free of viruses and protected from electronic attacks. Ensure that virus protection software is installed and updated with the latest virus definitions.

Display DeviceNOTE: Application should be downloaded and configured on the display device prior to clinical use.

NOTE: The display device requires the memory capacity to download the Spaulding Clinical application.

Mason Protocol SpecificationsFeature Specifications

Special FeaturesOff-line ECG viewer and configurable workflow management*, Automated installation via web

Waveform Display Off-line 12-lead ECG viewer

Off-line ECG Viewer

■ Speed: 5mm/sec, 10mm/sec, 12.5mm/sec, 25mm/sec, 50mm/sec

■ Gain: 5mm/mV, 10mm/mV, 20mm/mV Selectable by user

■ Print out: screen snapshot, sliding window based on speed

Print Formats ■ Configurable 12-leads by 10 seconds, 25mm/sec, 10mm/mV

■ Default is 4 groups of 3 leads by 2.5 seconds plus 1 - 10 second continuous lead II strip at 25mm/sec, 10mm/mV

Filters ■ AC Interference: 50/60 Hz

■ Low pass filters: 40/150 Hz

ECG Storage ■ Off-line: Temporary local storage. Auto upload to database when

network connection is established

■ On-line: Auto upload to database

* Spaulding Clinical Research, LLC will communicate with the Client on the details of ECG services, demographic data input fields and ECG Report formats.

http://www.java.com/en/download/manual.jsp#win



webECG Management SpecificationsThe Spaulding webECG Management Standard cloud-computing server instance provides customers with a balanced set of resources ideal for standard installation requirements. The specifications below are based on our standard instance, but based on the individual client need and utilization these may be modified to support more robust use cases.

Cloud-Based Server EnvironmentRequirements Specifications

RAM 15 GB minimum

Processor 4 virtual cores minimum

Storage 100 GB Virtual Storage minimum

Operating System Windows Server-based operating system. 64-bit platform.

Security Certifications and Third Party Accreditations

■ ISO 27001

■ SOC 1/SSAE 16/ISAE 3402

Reliability Metric 99.9% Uptime

Web Browser RequirementsRequirements Specifications

Adobe Flash Adobe Flash Version 11 or higher

Browser Software Mobile device native browser. Safari (Mac) and Internet Explorer (Windows)

Physician Tool Kit Site Application RequirementsRequirements Specifications

Java Java Runtime Environment Version 7 or higher

Operation System Windows XP, Windows Vista, Windows 7

RAM 512MB minimum

Storage 1GB (minimum)

Processor 1Ghz 32-bit or 64-bit processor (minimum)

Screen Resolution 1024 x 768 minimum

Internet Communication Internet communication required



webECG ApplicationFeature Specifications

Security HIPPA-compliant security included role-based access based on login credentials

Compliance Standards FDA 21 CFR Part II Compliant

Configuration ■ Clinical Research and Medical Configurations with ability to customize either application

■ Voice Biometrics defaults on for Clinical Research and off for Medical Orders Interface supported for Medical Configuration

User Levels ■ User Level: Capable of entering orders, reviewing data in database

■ Site Administrator: User level access, ability to customize the site configuration including adding users, managing passwords, customizing demographics, configuring reports, correcting demographic errors

■ Organization Administrator: All Site Administration access but ability to customize all sites for a given organization

3rd Party Algorithms ■ University of Glasgow 12-lead interpretative algorithm

■ AMPS ECG Measurement Tools

■ Voice Biometrics

Demographics ■ Medical Configuration Default: Patient ID, First Name, Last Name, Date of Birth

■ Optional: Age, Ethnicity, Gender, Technician, Ordering Physician, Referring Physician, Reading Physician and other fields can be customized by the organizational administrator

■ Clinical Research: Demographics are defined by the protocol

Stored Reports ■ 12-lead ECG Report with Comparison feature

■ Full Disclosure waveform review with ability for the user to modify:

■ Speed: 5 mm/sec, 10 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/sec

■ Gain: 5mm/mV, 10mm/mV, 20mm/mV

■ Leads: Number of waveforms displayed

■ Print: Screen shot based on the window displayed

■ 5-minute Spaulding webECG report that includes diagnostic statements, ECG Details, Beat data, Interval Values, Confirmed Physician Evaluation, Heart Rate Variability, T-Wave Morphology, QT Variability, Signal Averaged ECG, Summary ECG, Selected ECG

Configuration of Reports ■ Type of 12-lead ECG report: Summary, Selected, Specified

■ Configurable lead review: 12 x 1, 6 x 2, 3 x 4 plus continuous selectable rhythm lead at 25mm/sec and 10mm/mv

■ Filters: 100mmHz (default), 40mmHz



Electromagnetic CompatibilityElectromagnetic compatibility with surrounding devices should be assessed when using the Spaulding Electrocardiograph.

An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the device according to the international standard for EMC for medical devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).

The device should not be used adjacent to, or stacked on top of other equipment. If the device must be used adjacent to or stacked on top of other equipment, verify that the device operates in an acceptable manner in the configuration in which it will be used.

The use of accessories and cables other than those specified in the Introduction section, may result in increased emissions or decreased immunity of the device.

Guidance and Manufacturer’s Declaration: Electromagnetic EmissionsThe Spaulding Electrocardiograph is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment: Guidance

RF Emissions

CISPR 11

Group 1 The electrocardiograph uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B

The electrocardiograph is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic Emissions IEC 61000-3-2

Not Applicable

Voltage Fluctuations/Flicker Emissions IEC 61000-3-3

Not Applicable



Guidance and Manufacturer’s Declaration: Electromagnetic ImmunityThe Spaulding Electrocardiograph is intended for use in the electromagnetic environment specified in the table below. The user of the equipment should ensure that it is used in such an environment.

Emissions Test Compliance Compliance Level Electromagnetic Environment: Guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

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

Electrical fast transient/burst

IEC 61000-4-4

Participating display device must meet the criteria under IEC 60950

Surge

IEC 61000-4-5


Voltage dips, short interruptions, and voltage variations on power supply input lines

IEC 61000-4-11


Power frequency (50/60 Hz) magnetic field

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.



Guidance and Manufacturer’s Declaration: Electromagnetic ImmunityThe Spaulding Electrocardiograph is intended for use in the electromagnetic environment specified in the table below. The user of the equipment should ensure that it is used in such an environment.

Emissions Test IEC 60601 Test Level

Compliance Level Electromagnetic Environment Guidance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

3 Vrms

150 kHz to 80 MHz

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

Recommended separation distance:

d=[ ]√P3.5

3Vrms

d=[ ]√P3.5

3Vrms 80 MHz to 800 MHz

d=[ ]√P7

3V/m 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 fixed RF transmitters, as determined by an electromagnetic site survey*, should be less than the compliance level in each frequency range†. Interference may occur in the vicinity of equipment marked with the following symbol :

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to

2.5 GHz

3 V/m

80 MHz to

2.5 GHz

* Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, Spaulding Electrocardiograph 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 equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment.

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



Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Spaulding ElectrocardiographThe Spaulding Electrocardiograph is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment.

Rated Maximum Output Power of Transmitter (W) Separation Distance According to Frequency of Transmitter (m)

150 KHz to 800 MHz

d = 1.2 √P

800 MHz to 2.5 GHz

d = 2.3 √P

0.01 0.1m 0.2m

0.1 0.4m 0.7m

1 1.2m 2.3m

10 4.0m 7.0m

100 12.0m 23.0m

For transmitters rated at a maximum output power not listed above, the recommended separation 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: At 800 MHz, the separation distance for the higher frequency range applies.

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by the absorption and reflection from structures, objects, and people.



Spaulding Client App (Application)

Site ConfigurationReview the following minimum display device specifications to ensure the correct specifications for the display device hardware and software.

Minimum Display Device SpecificationsFor a complete listing of Specifications see the Display Device and Mason Workflow Protocol section.

Spaulding Client App Software InstallationOnce the site configuration is finalized between the Spaulding Clinical Research, LLC and the site, the Client Services Representative will provide the site with a Universal Resource Locator (URL) address, login credentials, and a Spaulding Clinical activation code required to install the client application.

NOTE: Reference the display device Specifications to ensure acceptable hardware configuration.

NOTE: For proper installations download the latest version of Java go to http://www.java.com/download, once complete the display device is ready for initial set up.

NOTE: This software installation is a one-time process per display device.

To install the client application on the display device, follow these steps:

1. Log into the display device.

2. Connect to the Internet using a web browser (example, Internet Explorer).

3. Navigate to the URL address provided by the Spaulding Clinical Research, LLC Client Services Representative.

4. In the Activation Code text box, type in the activation provided by Spaulding Clinical Research, LLC.

5. Click the Submit button.

6. The client application Installation Overview window will appear. Click the Launch button located at the bottom of the screen.



7. A Java Web Start window will open and an installation progress bar will show the status of the application as it is downloading to the display device.

8. When the software application has completed the installation progress, the web browser will automatically close and the Spaulding Client App icon will appear on the desktop.

Display Device User Identification and Access PermissionEach individual user requires a login e-mail address and password to access the Spaulding Client Application. A Spaulding Clinical Research, LLC Client Services Representative, provides the site’s user identification and password authorization.

9. Double click the Spaulding Client App icon to launch/open the Mason workflow protocol.

10. The Login window will open.

11. Enter login credentials.

NOTE: User login settings are selected in “Site Configuration”.



Physician Over-read Tools Software Installation

Physician Credentials and Work Assignments:Physicians are able to measure the ECG parameters and modify the Interpretation. The physician does not have privileges to modify the demographics. ECGs will be placed into the user’s list when they become available:

These instructions and methods are intended to address the study specific requirements and the workflow for reading ECGs within the Mason Workflow Protocol. Physiological considerations and diagnostic interpretation of the ECG are outside the scope of this document.

Initial Set Up

Obtain Java ApplicationNOTE: For proper installations download the latest version of Java go to http://www.java.com/download, once complete the display device is ready for initial set up.

Complete the following for the initial set up the Spaulding webECG over-read database. This step only needs to be completed once. After installation, it will be downloaded onto the user’s computer and accessed by the Spaulding Client App icon.

A system administrator will provide over-reader credentials.

Upon receipt of the credentials go to the Spaulding webECG login page provided to you with your credentials and login using these credentials.



This will open the physician-specific administration page.

Scroll to the bottom of this page and click on the CalECG Download menu option. CalECG is the viewing platform that assists the physician in over-reads.

Follow the instructions to save CalECG to the local system.



Return to the Spaulding webECG page and click on the Spaulding Reader Installation Launch button:

The application will install and launch automatically.

The Spaulding Physician Tools App icon will be placed on the desktop:




IIndex

Index

A

Associate Visit 40, 42

B

BatteryCharging the Battery 17Charging the Internal Battery 17LOW BATTERY 15, 23

C

Cable PortECG Cable Port 13, 23USB Cable Port 13, 17, 25, 38

CalECG 94CAUTIONS 10Cleaning Instructions 77Client Services Representative 26,

41, 91Copyright and Trademark

Notices 5

D

Definitions 1Demographic Information 4Device Data Summary 26, 41Diagnostic ECG Management

Solution 8Display Code 15, 78Display Device 1, 2, 10, 11, 12, 15,

17, 18, 23, 75, 83, 84, 88, 91, 92

E

ECGECG Cable Port 13ECG data 2, 4, 15, 19, 81ECG transmission 31, 45, 80

ECG Site Reader 71Electrode 2, 19, 20Electrode Location 19Electrode Location Preparation 19Electrode Placement 19, 20Electromagnetic Compatibility 87Equipment Preparation 17, 93Erase Indicator 15, 37

F

Frequency of Use 4

G

General Care 77Guidance and Manufacturer’s

Declaration 87, 88

H

I

Indications for Use 3Intended Users 3Internet Connection 31, 32, 45,

46, 80

L

Lead Quality Check 81Leadwire Color Identification 22LED display code 78LED Status Window 1, 13, 15, 17,

18, 23, 24, 29, 35, 36, 37, 78, 81

M

Main Function 13, 23, 24, 35, 36, 37, 77

Maintenance & Troubleshooting 77Manufacturer’s Responsibility 5Mason Protocol 83, 84, 93Mason Protocol software 2

Mason Protocol 1, 2, 11, 12, 15Microphone 7, 13

N

New Patient Enrollment 28, 43

O

Off-line Mode 30, 44Off-line Workflow 31, 45On-line Mode 30, 44Other Important Information 5

P

Patient Cable 23, 77, 82Patient Demographics 27, 35,

41, 42Patient Population 3Patient Preparation 19, 23, 35, 78Physician over-read tools 2, 83Preparing Patient Skin for ECG

Hookup 20

R

Responsibility of the End User 5Return Patient 31

S

Serial Number Identification 5Spaulding 12-lead ECG Patient

Cable 2, 4, 8, 9, 10, 12, 14, 75, 81, 84

12-lead ECG Patient Cable 9, 10, 23, 82

Spaulding Client App (Application) 91, 92

Spaulding Client App icon 1, 92, 93

Spaulding Electrocardiograph 2, 14, 15, 37, 77, 78

Spaulding Physician Tool Kit 55Spaulding Physician Tool Kit App

Icon 1Spaulding webECG Diagnostic ECG

management solution 2, 3, 4, 5, 8, 9, 10, 12

Spaulding webECG server 1, 2, 8, 12

Specifications 81, 82, 83, 84, 85, 86

Status Window 17Supplies 75System Description 2, 12

T

Troubleshooting 77, 78, 79

Index

II Index

Index

U

User Safety Information 8

V

Visit Confirmation 40, 42Visit Designation 29, 40Voice Recording

Voice data 15, 35, 36, 37, 41Voice Recording Example Script

36Voice Signal 17, 23, 25, 37, 38, 78

W

WARNINGS 8webECG management solution 27webECG reports 2


Spaulding Clinical Research, LLC 525 South Silverbrook Drive West Bend, Wisconsin 53095USATel: 262.334.6020Fax: 262.334.6067E-mail: [email protected] Number 9920-101-10-eng March 2013 V1.2

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Spaulding webECG Diagnostic ECG Management Solution … · AHA Lead Placement ... Electrode placement ... patients are ambulatory, however ECG’s are taken in a resting supine position