Clinical Reference Guide

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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

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Contact Information

Headquarters

Spaulding 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 Representative

Wellkang 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 Support

Tel: 262.306.3348 (Client Services) Tel: 262.334.6020

Fax: 262.334.6067

E-mail: [email protected]

Client Services Technical Support, Supplies and Accessories

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 Information

Spaulding Clinical Research, LLC

Local Representative: ____________________________ Address: ______________________________________ _____________________________________________ Tel: __________________________________________ Fax: _________________________________________

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i Contents

Contents

System Information

Introduction ...1

Definitions...1

Clinical Reference Guide Purpose ... 2

System Description ... 2

System Purpose ... 2

Intended Users ... 3

Indications for Use – Spaulding Electrocardiograph ... 3

Indications for Use – webECG ... 3

Patient Population ... 3

Environment ... 4

Methods and Frequency of Use ... 4

Notifications ... 5

Manufacturer’s Responsibility ...5

Responsibility of the End User ...5

Spaulding Electrocardiograph Serial Number Identification ...5

Copyright and Trademark Notices ...5

Other Important Information ...5

Limited Warranty ... 6

Equipment Symbols and Markings...7

User Safety Information ... 8

WARNINGS ... 8

CAUTIONS ... 10

NOTES ... 11

System Description ... 12

Spaulding Electrocardiograph ... 13

LED Status Window Indicators ...15

Equipment Preparation

Equipment Preparation ... 17

LED Status Window ...17

Charging the Battery via Display Device...17

Preparing the Patient for 12-lead ECG

Preparing the Patient ... 19

Preparing Patient Skin for ECG Hookup ...19

Electrode Location Preparation ...19

Electrode Placement ... 20

AHA Lead Placement ...20

IEC Lead Placement ...21

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ii Contents

Demographic Association

Data Collection and Transfer Using Voice ... 35

Recording ECG and Voice Data ...35

ECG Data ... 37

Re-Record Voice Signature Data ... 37

ECG and Voice Signal Data Transfer to Display Device ... 38

New Patient Enrollment ...39

Existing Patient Process ...41

View ECG ...44

Off-line Mode ... 45

Review ECG Data

ECG Data ...47

Review Patient Record ... 47

Review 12-lead ECG Report ...48

Review Full Disclosure Waveforms ...50

webECG Report ...51

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Assess Arrhythmia ... 63

Acronyms ... 65

Site Configuration & Management

Spaulding webECG Site Configuration and Management ...67

Logging In ... 67

Creating and Managing Users ... 67

Editing Patient Demographics ... 72

Supplies

Spaulding Electrocardiograph Supplies ... 75

Maintenance & Troubleshooting

General Care and Cleaning Instructions ...77

General Care ... 77

Cleaning the Patient Cable and the Spaulding Electrocardiograph ... 77

Methods ... 77

Troubleshooting ...78

LED Status Window Display Code Troubleshooting ... 78

Voice Signature Data Troubleshooting ... 79

ECG Data Troubleshooting... 79

Troubleshooting the Display Device ...80

Password Login Errors ...80

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iv Contents

Electromagnetic Compatibility ...87

Spaulding Client App (Application) ... 91

Site Configuration ...91

Minimum Display Device Specifications ...91

Spaulding Client App Software Installation ...91

Display Device User Identification and Access Permission... 92

Physician Over-read Tools Software Installation ...93

Physician Credentials and Work Assignments: ... 93

Initial Set Up ... 93

Index

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1 System Information

System Information

Introduction

Definitions

Description 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.

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System Information

Clinical Reference Guide Purpose

This 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 andVoice Signal Data on the Spaulding Electrocardiograph ■ Transmitting ECG and Voice Signal Datato 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 Description

The 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 Purpose

The 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.

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System Information

Intended Users

The 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 Electrocardiograph

The 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 – webECG

The 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 Population

The 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.

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4 System Information

System Information

Environment

The 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 Use

The 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.

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System Information

Notifications

Manufacturer’s Responsibility

Spaulding 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 User

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

Spaulding Electrocardiograph Serial Number Identification

The 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 Notices

This 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 Information

The 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.

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6 System Information

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.

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System 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

0086 CE 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 REP

Wellkang 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

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System Information

User Safety Information

This 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.

WARNINGS

This 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.

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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 single-used. All electrodes and single-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 reSingle-used.

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.

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10 System Information

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.

CAUTIONS

No 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.

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System Information

NOTES

As 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.

4

LD

7

MEDICAL EQUIPMENT

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN 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.

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12 System Information

System Information

System Description

The 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

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System Information

Spaulding Electrocardiograph

1 2

1. LED Status Window 2. Main Function Button

Top View

5

3 4

3. Microphone 4. ECG Cable Port 5. USB Cable Port

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System Information

6 ₅

6. USB Cable

Display Device Connections 4

7

7. Spaulding 12-lead ECG Patient Cable

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System Information

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

FULL Electrocardiograph 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 INDICATOR Voice signature and ECG data have been transferred to the display device and the electrocardiograph is deleting the data from internal memory.

C

CHARGING Electrocardiograph 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

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16 System Information

System Information

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17

Equipment Preparation

This 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 Window

The 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 Device

1. 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

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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

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19

Preparing the Patient for the 12-lead ECG

Preparing the Patient

for 12-lead ECG

Preparing the Patient

In 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 Hookup

It 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 Preparation

Follow 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

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Preparing the Patient for 12-lead ECG

20 Preparing the Patient for the 12-lead ECG

Electrode Placement

AHA Lead Placement

When 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

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

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

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21

Preparing the Patient for the 12-lead ECG

Preparing the Patient

for 12-lead ECG

IEC Lead Placement

C1 C2 C3 IEC C4 C5 C6 Angle of Louis R L F N

IEC Lead Placement

R Red Right Arm Place the electrode on the inside of the right arm on the fleshy part of the arm

L Yellow Left Arm Place the electrode on the inside of the left arm on the fleshy part of the arm

N Black Right Leg Place the electrode slightly on the inside of the right thigh on the fleshy part of

F Green Left Leg Place the electrode slightly on the inside of the left thigh on the fleshy part of

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

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Preparing the Patient for 12-lead ECG

22 Preparing the Patient for the 12-lead ECG

Leadwire Color Identification

Each 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

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23

Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG

with Physician Orders

NOTE: Screen examples are for representation purposes only.

Data Collection and Transfer Using a Physicians Order

The 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 Collection

This 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

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24 Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG with Physician Orders

NOTE: Screen examples are for representation purposes only.

ONE HORIzONTAL BAR

TWO HORIzONTAL BARS

THREE

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

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25

Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG

NOTE: Screen examples are for representation purposes only.

ECG Data Transfer to Display Device

This 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.

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26 Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG with Physician Orders

NOTE: Screen examples are for representation purposes only.

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.

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27

Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG

NOTE: Screen examples are for representation purposes only.

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.

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28 Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG with Physician Orders

NOTE: Screen examples are for representation purposes only.

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: SC102 Age: 48 Gender: Male Physician: Dr. Sam Smith

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

Referred By: Dr. Nathanial Meriweather

Sinus rhythm Normal ECG Unconfirmed I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 II

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29

Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG

NOTE: Screen examples are for representation purposes only.

New Order

This 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.

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30 Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG with Physician Orders

NOTE: Screen examples are for representation purposes only.

View ECG

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

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

Patient ID: SC102 Age: 48 Gender: Male Physician: Dr. Sam Smith

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

Referred By: Dr. Nathanial Meriweather

Sinus rhythm Normal 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

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

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31

Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG

NOTE: Screen examples are for representation purposes only.

Off-line Mode

In 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.

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32 Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG with Physician Orders

NOTE: Screen examples are for representation purposes only.

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

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33

Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG

NOTE: Screen examples are for representation purposes only.

Orders

The 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

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34 Acquiring a 12-lead ECG with Physician Orders

Acquiring a 12-lead ECG with Physician Orders

NOTE: Screen examples are for representation purposes only.

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.

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35

Acquiring a 12-lead ECG with Voice Demographic Association

Acquiring a 12-lead ECG with Voice

Demographic Association

NOTE: 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 Feature

NOTE: 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 Data

This 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.

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36 Acquiring a 12-lead ECG with _{Voice Demographic Association}

Acquiring a 12-lead ECG with

Voice Demographic Association

NOTE: Screen examples are for representation purposes only.

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 bir th is: _______ My gender is:_____________ The Sponsor of th is study is: ______________________

The Protocol nu_{mber is:}

______

The Visit Iden_{tifier is:}

_______

I am participatin_{g in a research} study. My v_{oice is bein}

g recorded for the study i_{dentification.}

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.

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37

Acquiring a 12-lead ECG with Voice Demographic Association

Acquiring a 12-lead ECG with Voice

NOTE: Screen examples are for representation purposes only.

ECG Data

1. 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

THREE

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

If 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.

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38 Acquiring a 12-lead ECG with _{Voice Demographic Association}

Acquiring a 12-lead ECG with

Voice Demographic Association

NOTE: Screen examples are for representation purposes only.

ECG and Voice Signal Data Transfer to Display Device

This 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.

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39

Acquiring a 12-lead ECG with Voice Demographic Association

Acquiring a 12-lead ECG with Voice

NOTE: Screen examples are for representation purposes only.

New Patient Enrollment

NOTE: 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