REF 9515-147-61-ENG Rev H1

H-Scribe Rx HOLTER ANALYSIS SYSTEM

USER MANUAL

Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.

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

®

Copyright © 2015

by Mortara Instrument, Inc. 7865 N. 86th Street

Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. H3+, H12+, E-Scribe, H-Scribe, Surveyor, and VERITAS are trademarks of Mortara Instrument, Inc. Microsoft and Windows are trademarks or registered trademarks of Microsoft Corporation. 4.32.

TECHNICAL SUPPORT AND SERVICE

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Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com

European Union Representative Mortara Instrument Europe, s.r.l. (European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: techsupport@mortara.com

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 Hospital Customers: orders.us@mortara.com Physician Practice: orderspc.us@mortara.com U.S. Distribution: orderspc.us@mortara.com Mortara Instrument Germany Bonifaciusring 15 45309 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Baulkham Hills NSW 2153 Unit 28, 9 Hoyle Avenue Castle Hill NSW 2154 Australia Tel: +61 2 8070 9303 Fax: +61 2 9899 9478 Mortara Dolby UK Ltd. Units 11 & 12, Scion House Stirling University Innovation Park Stirling FK9 4NF Scotland Tel: +44.1786.444980 Fax: +44.1786.446630

NOTICES

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Manufacturer’s Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance only if: Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons

authorized by Mortara Instrument, Inc. • The device is used in accordance with the instructions for use. Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. Equipment Identification Mortara Instrument, Inc. equipment is identified by serial and part numbers on the side, back, or bottom of the device. Care should be taken so that these numbers are not defaced. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated to another language without prior written consent of Mortara Instrument, Inc. Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no commitment to update or to keep current the information contained in this document.

WARRANTY INFORMATION

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Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Mortara, or if not otherwise noted, for a period of twelve (12) months from the date of shipment. Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date of first use, whichever is sooner. Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for a period of 90 days. 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 Mortara;

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 Mortara;

f) Other events outside of Mortara’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, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’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 Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold.

WARRANTY INFORMATION

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EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA 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 MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA 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.

USER SAFETY INFORMATION

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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.

Warning(s)

Device 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.

To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged into a hospital grade outlet.

To maintain operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact must be in compliance with IEC 60601-1 and IEC 601-2-25.

To maintain operator and patient safety, only use parts and accessories supplied with the device and available through Mortara Instrument, Inc.

If a possible explosion hazard exists, do not use the device in the presence of flammable anesthetics.

Before attempting to use the device for clinical applications, the operator must read and understand the contents of the user manual and any documents accompanying the device. Contact Mortara service for additional training options.

USER SAFETY INFORMATION

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Caution(s)

Do not attempt to clean the device or patient cables by submerging into a liquid, autoclaving, or steam cleaning. Wipe the exterior surface of the device with an alcohol-free sterilizing disinfectant avoiding aggressive

detergents; dry with a clean cloth. The internal battery is a lithium type and is maintenance free. If the battery appears to become defective,

contact Mortara Instrument, Inc. Technical Support Group. A final report that includes the summary, profile, trends, and five pages of strips (including three pages of 12-

lead strips and one 6-minute strip page) in PDF format is approximately 1,760 KB in size. Final reports that are saved to the local hard drive will cause the device to fill over a period of time. These files will need to be removed from the hard drive prior to causing the device to cease to operate. Periodic checks of the device’s capacity are recommended. Contact Mortara Instrument, Inc. Technical Support Group for assistance with removal of these files.

System environment:

Operating temperature: +10 to +35C Storage temperature: -40 to +65C Relative humidity: 8% to 80% Altitude: -50 to 10,000 ft.

Note(s)

Poor patient preparation prior to electrode attachment may affect the recording and could interfere with the operation of the device.

An ambulatory 12-lead ECG obtained with torso-located limb electrodes is not equivalent to a conventional diagnostic ECG.

EQUIPMENT SYMBOLS AND MARKINGS

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Symbol Delineation

Atention, consult accompanying documents

Indicates compliance to applicable European Union directives

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

EQUIPMENT SYMBOLS AND MARKINGS

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TABLE OF CONTENTS

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INTRODUCTION SECTION 1

Manual Purpose ............................................................................................................................................................. 1 Audience ........................................................................................................................................................................ 1 Intended Use .................................................................................................................................................................. 1 Indications for Use ........................................................................................................................................................ 1 System Description ........................................................................................................................................................ 2 H-Scribe Rx Specifications .......................................................................................................................................... 3

SELECT PATIENT LIST SECTION 2

Power-on the H-Scribe Rx System ............................................................................................................................... 5 Select Patient List .......................................................................................................................................................... 5 Scan Criteria .................................................................................................................................................................. 6

HOLTER ACQUISITION SECTION 3

H3+ Digital Holter Recorder ......................................................................................................................................... 7 CF Memory Card (H12+ Digital Holter Recorder) ....................................................................................................... 9 Web Server .................................................................................................................................................................. 10 Surveyor Central .......................................................................................................................................................... 10 Enter Patient Information ............................................................................................................................................ 10 Channel Assignment .................................................................................................................................................... 11

HOLTER ANALYSIS SECTION 4

Scanning Patient Recordings ....................................................................................................................................... 13 AutoScan .............................................................................................................................................................. 13 Prospective Scan .................................................................................................................................................. 13

ECG Waveform Color Codes ...................................................................................................................................... 15 Alternate Displays ....................................................................................................................................................... 16

Templates Display ................................................................................................................................................ 16 Supraventricular Template Group ........................................................................................................................ 17 Profile Display ...................................................................................................................................................... 18

Editing and Adding Diary Events ................................................................................................................. 18 ECG Display ........................................................................................................................................................ 20

Labeling Beats in the ECG Display .............................................................................................................. 21 Labeling Regions in the ECG Display .......................................................................................................... 21 Using the Calipers in the ECG Display ......................................................................................................... 22 ECG Grid ...................................................................................................................................................... 22 Context View ................................................................................................................................................ 22 Interaction between Displays ........................................................................................................................ 23 Print Screen ................................................................................................................................................... 23 Lead Fail Conditions ..................................................................................................................................... 24 Lead Fail Table for 12-Lead ECG Recordings ............................................................................................. 25

Trend Display ....................................................................................................................................................... 26 Superimposition Display ...................................................................................................................................... 27

Split Screen View ........................................................................................................................................................ 28 Strip List Review ......................................................................................................................................................... 28

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HOLTER ANALYSIS SECTION 4 (cont’d.)

Final Reports ............................................................................................................................................................... 28 Report Preview .............................................................................................................................................. 28 Report Headers .............................................................................................................................................. 28 Report Options .............................................................................................................................................. 28 Selecting Hours for Full Disclosure .............................................................................................................. 29 Override ........................................................................................................................................................ 29 Acronyms ...................................................................................................................................................... 29

Closing the Patient Recording ..................................................................................................................................... 30 48-Hour Recordings .................................................................................................................................................... 30 Pull-Down Menus ........................................................................................................................................................ 31 Help ............................................................................................................................................................................. 36 Icons ............................................................................................................................................................................ 37

FINAL REPORTS SECTION 5

Summary Page ............................................................................................................................................................. 39 Profile Page ................................................................................................................................................................. 43 Trend Page ................................................................................................................................................................... 43 Strip Pages ................................................................................................................................................................... 44 48-Hour Recordings .................................................................................................................................................... 44

INTERFACE EXPORT SECTION 6

Introduction ................................................................................................................................................................. 45 Interface Export Setup and Data Export ...................................................................................................................... 45 Interface Export File Name and Structure ................................................................................................................... 46 Interface Exported Status Files .................................................................................................................................... 46 Interface Export and H-Scribe Rx Custom ID ............................................................................................................. 46 Interface Export Schema File ...................................................................................................................................... 46

RX XML EXPORT SECTION 7

Introduction ................................................................................................................................................................. 47 Rx XML Export Setup and Data Export ..................................................................................................................... 47 Rx XML Strip Export .................................................................................................................................................. 50 Rx XML Waveform Export ......................................................................................................................................... 50 Rx XML File Name and Structure .............................................................................................................................. 51 Rx XML Exported Status Files ................................................................................................................................... 52 Rx XML Export and H-Scribe Rx Custom ID ............................................................................................................ 52 Rx XML Schema Files ................................................................................................................................................ 52

RX EXPORT TO E-SCRIBE SECTION 8

Introduction ................................................................................................................................................................. 53 Requirements ............................................................................................................................................................... 53 Rx Export to E-Scribe Setup and Data Export ............................................................................................................ 53 UNIPRO ECG Exported Status Files .......................................................................................................................... 57 Rx Export to E-Scribe and E-Scribe Custom ID ......................................................................................................... 57

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ARCHIVE SECTION 9

Introduction ................................................................................................................................................................. 59 Formatting New CD-RW or DVD+/-RW Discs .......................................................................................................... 60 Using Formatted Discs ................................................................................................................................................ 60 Archiving a Single Patient ........................................................................................................................................... 61 Batch Archiving........................................................................................................................................................... 61 Restoring Patient Recordings from Archive ................................................................................................................ 62

AUDITING CHANGES SECTION 10

Support for Auditing Changes to the Patient Record .................................................................................................. 63 Audit Trail File Location ............................................................................................................................................. 64

SETUP SECTION 11

H-Scribe Rx Assembly ................................................................................................................................................ 65 H-Scribe Rx Interconnections ..................................................................................................................................... 65 Interacting with Windows Environment ...................................................................................................................... 66 H-Scribe Rx Operation ................................................................................................................................................ 66 System Security and Privacy Setup ............................................................................................................................. 66

Screen Saver and Password Selection .................................................................................................................. 66 Changing a Password ........................................................................................................................................... 67

Network Connection Security and Privacy Setup ....................................................................................................... 67 Shared Files and Folders Security ........................................................................................................................ 67

User Profiles Setup ...................................................................................................................................................... 67 Archive Setup .............................................................................................................................................................. 69 Audit Trail Files Setup ................................................................................................................................................ 69 Patient List Locations Setup ........................................................................................................................................ 69 High-Fidelity 12-Lead ECG Export and E-Scribe Custom ID Setup .......................................................................... 71 Configuration Files Setup ............................................................................................................................................ 72 Interface Export Setup ................................................................................................................................................. 74 PDF Only Export Setup ............................................................................................................................................... 74 Rx XML Export Setup ................................................................................................................................................. 75 Custom ID Setup ......................................................................................................................................................... 76 Full Name Field ........................................................................................................................................................... 81 Export File Name Format Setup .................................................................................................................................. 84

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INTRODUCTION SECTION 1

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Manual Purpose This manual is intended to provide the user with information about using and understanding the H-Scribe™ Rx Holter analysis system:

Acquire patient data Enter, modify, and delete patient information Analyst review and editing Final report generation Export Holter statistics and waveform results in XML and RX XML formats Export Holter ECG files to E-Scribe™ Rx data management system Archive/Restore System setup Customize demographic labels

NOTE: This manual may contain screen shots. Any screen shots are provided for reference only and are not intended to convey actual operating techniques. Consult the actual screen in the host language for specific wording.

Audience This manual is written for clinical professionals who are expected to have a working knowledge of medical procedures and terminology as required for monitoring cardiac patients.

Intended Use H-Scribe Rx Holter system is intended to acquire, automatically analyze, edit, review, report and store prerecorded ECG data of patients that have been connected to compatible tape or digital recorders. The cardiac data and analysis provided by H-Scribe Rx is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns.

Indications for Use The H-Scribe Rx system is indicated for use in a clinical setting, by qualified medical professionals only, for patients requiring ambulatory (Holter) monitoring of 24-48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. The analysis software package includes, among others, detection and reporting features appropriate to the indications below:

Evaluation of adult patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia

Evaluation of adult patients for ST segment changes

Evaluation of adult patients with pacemakers

Reporting of time domain heart rate variability

Evalulation of infant patients limited to QRS detection only

SECTION 1

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System Description The H-Scribe Rx is a high-speed, PC-based Holter scanner. Designed in conjunction with the H3+™ and H12+™ digital Holter recorders, the H-Scribe Rx provides three channels of full-disclosure data for arrhythmia analysis, and incorporates Mortara Instrument’s exclusive VERITAS™ ECG algorithms for superior beat detection and ST segment analysis to acquired recorded ECG data. ECG data from an H3+ or a CF memory card is downloaded for analysis to the H-Scribe Rx. After acquisition the recorder or CF memory card is erased and prepared for the next recording session using the H-Scribe Rx application software. The optional H-Scribe Rx review station offers equivalent capabilities to the H-Scribe Rx except for data acquisition. Patient recordings must be acquired at the H-Scribe Rx or a networked remote download station. The optional H-Scribe remote download station allows either recorder or compact flash (CF) memory card data acquisition and erasure, entry of patient information, automatic scanning, and archive to media or other network drive. It cannot review ECG data. Recordings must be reviewed at any networked H-Scribe Rx or review station where the final report is also generated. The Surveyor™ Central system (software versions 3.00 and later) receives 12-lead ECG data from a Mortara digital transmitter. The full-disclosure monitoring data can be imported into the H-Scribe Rx for Holter analysis through the use of the H-Scribe Surveyor Import application. Any Surveyor Central patient monitoring period up to 48 hours in duration can be chosen. Standard or high-fidelity sampling is selected when the patient monitoring data is imported. Holter recordings can also be acquired from a web server when they have been uploaded from a remote location with the H-Scribe Web Upload option. Report formats include scan criteria, report summary, rhythm profile, 24-hour trends of all arrhythmias and ST segment changes, automatic and operator-selected strips in one, two, and three or twelve leads, and full disclosure of one, two or three channels. Multiple recordings with analyses are stored on the hard drive of the H-Scribe Rx or a network server in patient slots. The user can select a patient slot to store a new recording or to review existing analyses. Long-term storage of full-disclosure patient recordings is accomplished by the archive feature. Archived patient recordings can be restored to the H-Scribe Rx for further analysis, review, report export, or printing at any time.

SECTION 1

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H-Scribe Rx Specifications

Feature Specifications

CPU Pentium class tower with 2.66 GHz (minimum) processor and 1 GB RAM (minimum)

Operating System Microsoft® Windows™ XP with SP2 or SP3; Windows Vista Business with SP1; or Windows 7

Storage 160 GB hard drive (minimum), DVD+/-RW or CD-RW disc (any arbitrary drive)

Input Devices H3+ USB interface cable CF memory card reader Extended keyboard and 2-button mouse with wheel 3.5” floppy disk drive ● DVD+/-RW drive

Monitor Color display, 19” with 1280 x 1024 (minimum) resolution or 24” wide-screen LCD display with 1920 x 1200 resolution

Printing Device High-speed Windows LaserJet printer

Operating Environment Operating temperature: +10 to +35 C Storage temperature: -40° to +65° C Relative humidity: 8% to 80% Altitude: -50 to 10,000 ft.

Power Requirements 100 - 240 VAC at 50/60 Hz 800 watts maximum; 400 watts average

Network Requirements 10 Mbps dedicated Ethernet connection (minimum) Network shares created on H-Scribe systems to permit

access from other H-Scribe systems Windows security configured to allow access from other

H-Scribe systems as appropriate

Network Recommendations 100 Mbps connection or better DHCP services for automatic IP address assignment DNS (preferred) or WINS name resolution services

SECTION 1

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SELECT PATIENT LIST SECTION 2

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Power-on the H-Scribe Rx System Turn on the power to the monitor and printer. Press the power button on the front panel of the CPU tower. To provide patient information security, the H-Scribe Rx is delivered with password protection enabled. Password protection can be disabled upon request by authorized Mortara Instrument personnel. Upon startup, you are instructed to enter a user name and password to logon. The factory defaults are:

User Name: administrator Password: hsnt4us

Once you logon, the H-Scribe Rx displays the patient list on the Select Patient screen. (See Section 11 to change a user profile and/or password.)

Select Patient List The Select Patient screen displays all stored patient recordings. The system is delivered with sample acquired patient recordings in patient slots #1 and #2. Delete the sample recordings when they are no longer needed. The Status column provides information about the recording that is helpful in managing patient records.

Status flags for 48-hour recordings will only appear when they apply to both 24-hour periods.

A = Acquired

S = Scanned

B = Archived

P = Printed

R = Reviewed

X = Interface Exported

> = Rx XML Exported

U = Unipro ECG Exported

E = Empty

“48 Hrs” will appear in the Date Recorded column when the recording duration is greater than 24 hours.

About will open a window displaying your system software version and enabled features. The H-Scribe List of Enabled Features dialog also contains your dongle serial number and allows entry of a permission code to upgrade your system features.

Sort the Select Patient list by clicking on a column header e.g., “Last Name” will sort the list in alphabetical order by the patient’s last name. A second click will sort the list in reverse order. Two asterisks indicate the sort selection.

A single click on a row highlights the patient data allowing you to open the recording for review and editing. You can Delete Patient when the recording is no longer needed, Archive the recording, or edit the Diary List.

Access any other patient list by clicking on the Patient List drop-down menu and selecting the desired patient list name.

Select acquisition location and method by clicking on an empty slot and then clicking on the drop-down list next to Connect To:. Acquisition methods, depending on your system options, can be H3+ Recorder, Compact Flash, Web Server, or Surveyor Data.

SECTION 2

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Archive allows you to copy the recording to a backup location; Restore copies the full-disclosure recording with all previous edits back to the H-Scribe Rx for later review, editing, export, or printing.

Diary List allows you to access the selected patient’s diary list to edit, add, or remove events prior to reviewing the recording. You can also enter patient symptoms or activities that occurred at the time of acquisition. See Section 4 for details.

Scan Criteria To review and modify the current settings of the Scan Criteria, click Scan Criteria on the Patient Information screen prior to scanning. Scan Criteria is also available through selection of the Edit pull-down menu after a patient recording is opened for review. Current settings are displayed as:

SVPB Prematurity in percent Pause in milliseconds ST Segment Depression and ST Segment Elevation in microvolts Tachycardia in beats per minute (BPM) Bradycardia in BPM Minimum Tachy/Brady episode in HH:MM:SS

The Automatically Detect Atrial Fibrillation checkbox is located in both this window and the Patient Information window. Advanced Criteria parameters include settings for a Long RR/Pause, and an enable/disable option for Pause excluded in HR. Modifications to these settings take immediate effect for the current patient when OK is selected. Modifications to these settings take immediate effect for the current patient and all future patients when Save As Default is selected. If you wish to add scan criteria settings to your saved default settings, select Load Defaults.

NOTE: Changes made to the Automatically Detect Atrial Fibrillation checkbox or the SVPB Prematurity % value after initial acquisition and scan requires rescanning of the recording. Rescanning the patient data causes the user’s editing changes to be lost. It is recommended that you verify Scan Criteria before scanning is initiated.

NOTE: The thresholds for Tachycardia and Bradycardia BPM and HH:MM:SS duration must be exceeded in order for a tachy/brady episode to be detected and reported in the final report. Periods of artifact that occur within a tachy/brady episode will be considered to have the same HR and will be included in the duration of the episode.

HOLTER ACQUISITION SECTION 3

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H3+ Digital Holter Recorder The H3+ records two or three channels of continuous ECG data over a 24- or 48-hour period. Acquiring Patient Data Remove the AAA battery from the H3+. Remove the patient cable and insert the USB interface cable connector into the recorder’s input connector. A tone sounds indicating that the H-Scribe Rx has detected the recorder. The recorder LCD will show “USB” indicating a powered connection. To begin the acquisition process, click once to highlight the empty slot in the Select Patient list where you wish to store the new recording. Click on Connect To:. After a slight delay, a Connect To H3+ screen is displayed. Recording Information shows information about the patient recording:

o The ID # that was entered prior to starting the recording, the time and date the recording started, the duration of the recording and number of channels used (2 channels or 3 channels), and recorded data status.

o Status will show one of two messages: —Has Been Acquired Before —Has Never Been Acquired

Recorder Information shows information about the H3+. Channel Assignment may be helpful for 3-channel recordings when leads II and/or V are noisy or disconnected during recording. Details about this feature are explained at the end of this section. Select Start and data acquisition (processing) will begin. Data Processing Status shows a progress bar as the data is acquired. Once processing is complete, the Patient Information screen will be displayed. You may select Done at any time to close the Connect To H3+ window. When Done is selected during processing, the data acquisition will be cancelled.

SECTION 3

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Erasing Patient Data Before a new patient recording can begin, previous data must be erased from the H3+. Click on the system

Open Patient icon to open the Select Patient list. Click first on Erase…, then click on OK.

If Erase… is selected before all the data has been acquired, you will be prompted that the data in the recorder have not yet been acquired.

If all the data has been acquired, Erasing recorder, please wait… will be displayed for a few seconds followed by the Set Time On H3+ Recorder dialog window:

The current H3+ time is shown in the text area.

The H-Scribe Rx system time and date are shown in the Time and Date fields.

The Bypass button allows you to keep the current settings; the Set Time button will update the recorder. Patient ID Entry Use Enter ID to enter the patient identification number into the H3+ prior to starting a new patient recording, and to reset the time and date. You will be prompted to erase the previous recording if it has not been erased or acquired. If the previous recording has been acquired, the recording will be erased without a prompt. The Set Time On H3+ Recorder dialog window appears allowing you to change the recorder time and date if needed. Next, the Save Demographics To Recorder dialog window appears allowing entry of up to 25 alphanumeric characters for the ID #. After the ID # is entered, select Save and the ID # value will be written to and stored in the H3+.

SECTION 3

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CF Memory Card (H12+ Digital Holter Recorder)

The H12+ records 12-lead ECG data continuously for up to 48 hours with a CF memory card. The H12+ is also capable of acquiring high-fidelity digital waveforms at 1,000 samples per second when a high-fidelity CF memory card is used.

Acquiring Patient Data

Remove the CF memory card from the H12+ and insert it into the H-Scribe Rx CF reader. Select Compact Flash from the drop-down list next to Connect To:.

To begin the acquisition process, click once to highlight the empty slot in the Select Patient list where you wish to store the new recording. Click on Connect To:. After a slight delay, a Connect To Compact Flash screen is displayed.

NOTE: Recording Duration and Analyzed Data are normally the same in length. The Analyzed Data duration is shorter only if periods of lead fail occur during the recording and no beats are detected.

Click on Acquire to initiate the actual download of the recording to the H-Scribe Rx. The acquisition process requires a few seconds to complete, after which time the Patient Information window is displayed.

Erasing Patient Data

Before a new patient recording can begin, previous data must be erased from the CF memory card. Click on the

system Open Patient icon to open the Select Patient list. Click first on Erase…, then click on OK.

If the CF memory card contains data that has not been acquired, an attention notice is displayed informing you the “Card contains ECG that has never been acquired …”. To acquire the data before erasing (formatting) the card, click on Cancel.

The formatting process requires a few seconds. A progress bar and an hourglass are displayed during the process. Upon successful completion, the format window will close and the Select Patient screen is displayed.

NOTE: Removing the card during formatting may result in damage to the card.

Patient ID Entry

Use Enter ID… to enter patient information onto the CF memory card prior to starting a new patient recording.

You will be prompted to erase the CF memory card if it has not been formatted.

Use drop-down Quick Lists for Indications, Medications, Hookup Tech, Analyst, and Referring and Reviewing Physicians selection. For Indications and Medications, select user-defined Quick List entries in the boxes to their right and append them to the two fields by clicking on the corresponding <<+ button. You can also enter free text in any of these fields.

The information you enter in this window is written and stored to the CF memory card after selecting Save and will appear in the Patient Information window when the data is acquired. The ID # that you enter will display on the recorder’s LCD during patient hookup to ensure that the CF memory card demographics match the patient.

SECTION 3

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Web Server

Acquiring Patient Data

To begin the acquisition process, click once to highlight the empty slot in the Select Patient list where you wish to store the new recording. Select Web Server from the drop-down list, then click on Connect To:.

The Connect To Web Server screen will be displayed. Sort by last name, first name, ID #, site, or date recorded by clicking on the appropriate column header. Two asterisks indicate the sort selection.

Filter the originating sites in this list by using the drop-down list.

Click to highlight the desired recording, then select Acquire.

File conversion, processing, and merging will automatically occur in three steps. If Cancel is selected at any time during these steps, the operation will be cancelled.

Once completed, the recording is removed from the Connect To Web Server list. The Patient Information window automatically displays prompting you to enter patient information.

Surveyor Central

Acquiring Patient Data

To begin the acquisition process, click once to highlight the empty slot in the Select Patient list where you wish to store the new recording. Select Surveyor Data from the drop-down list, then click on Connect To:.

The Connect To Surveyor Data screen will be displayed. Sort by last name, first name, ID #, or date recorded by clicking on the appropriate column header. Highlight the desired recording, then click on Acquire.

Once acquired, the file is removed from the Surveyor Data location. The Patient Information window will open and the recording is available for review, editing, printing, export, and archive not unlike a recording that has been directly acquired.

Enter Patient Information

The Patient Information screen allows you to populate blank information fields. If entered, Date Of Birth will automatically calculate the age. Entry must match the H-Scribe Rx computer regional format settings (e.g. MM/DD/YYYY). If not entered correctly, you will be prompted.

The Recorder: field displays the type and software version of the recorder that was used and cannot be edited.

Use drop-down Quick Lists for Indications, Medications, Hookup Tech, Analyst, and Referring and Reviewing Physicians selection. For Indications and Medications, select user-defined Quick List entries in the boxes to their right and append them to the two fields by clicking on the corresponding <<+ button. You can also enter free text in any of these fields.

NOTE: Edit any of the drop-down Quick Lists by selecting Quick Lists in the system’s Edit menu at any time.

If a recording duration is greater than 24 hours, the Patient Information dialog will display a Process As section that allows you to choose 48 Hour Recording or 24 Hour Recording. This is useful when you wish to acquire and analyze only the first 24-hour period. This section will not appear when the recording duration is 24 hours or less.

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Channel Assignment Channel assignment displays the channels used for analysis at the H-Scribe Rx depending on the patient cable connected to the H3+. 2-channel recordings use both channels as input for analysis. The Channel Assignment field will not

contain any selections or information when a 2-channel patient cable is connected to the H3+.

3-channel recordings default to Lead II and Lead V as the inputs for analysis. To improve beat detection and labeling when there is lead fail or significant amounts of interference, you can rescan the data using different input leads.

Standard leads offer the following lead choices: o Analysis Input A: Lead I and Lead II o Analysis Input B: Lead II and Lead V

Alternate leads offer the following channel choices: o Analysis Input A: C1 and C2 o Analysis Input B: C2 and C3

There can be many possible combinations of leads in fail. The following table will help you determine the best choice for lead selections when a rescan is required.

Electrode(s) in Fail

Standard Leads Flat Lined

Best choice for Standard Leads

Alternate Leads Flat Lined

Best choice for Alternate Leads

LA I, V II C1 C2, C3

RA I, II, V None C2, C3 C1

LL I, II, V None C1, C2 C3

V V I, II C3 C1, C2

LA, RA I, II, V None C1, C2, C3 None

LA, LL I, II, V None C1, C2 C3

LA, V I, V II C1, C3 C2

RA, LL I, II, V None C1, C2, C3 None

RA, V I, II, V None C2, C3 C1

LL, V I, II, V None C1, C2, C3 None

Example: if the LA (left arm) electrode is disconnected for a significant portion of the recording, you can select Rescan from the Patient drop-down list. Choose Alternate Lead C2 for Analysis Input A, and C3 for Analysis Input B. This offers an alternative to having only one good channel for the recording.

To re-analyze a recording, select Rescan from the Patient pull-down menu. If the recording is 3-channel, you will be prompted with: Do you want to reassign which channels are used for the reanalysis? If Yes is selected, the Rescan H3+ Recording window will open to allow you to select the desired leads and channels. You can click on Standard Leads or Alternate Leads and the appropriate selections will appear. Alternate leads offer a good solution to repeating the recording session when the RA or LL leads are in fail. In cases where a combination of leads such as LA and RA, or RA and LL, or LL and V are in fail, there is no rescan alternative and the recording will require a repeat session.

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HOLTER ANALYSIS SECTION 4

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Scanning Patient Recordings H-Scribe Rx supports both retrospective (“AutoScan”) and prospective scan modes. The workflow for the two modes is different but significant similarities do exist. The difference between the two scan modes is evident during analyst review and editing where ECG events are reviewed and selected for inclusion in a system-generated final report. Typical Workflow

1. Erase previous data on recorder

2. Patient preparation and hookup

3. Holter recording period

4. Acquisition of data at H-Scribe Rx

5. Pre-analysis scan

6. Analyst review & editing

AutoScan Review & Editing Prospective Scan Review & Editing

Template review ECG strip selection using

Profile display and ECG view Trend review Superimposition review

Set stop-event criteria ECG review and strip selection in

page or superimposition mode Template review ECG strip selection using Profile

display Trend review

7. Report generation and export During analysis, the user must make certain that specific criteria such as Pause-Length, ST Segment Elevation and Depression, Tachycardia/Bradycardia thresholds, and Supraventricular Prematurity Percent (%) are appropriate for the individual recording. During the review steps, decisions made by the system are verified. After entering patient information and verifying appropriate checkboxes and scan criteria have been selected, click on either AutoScan or Prospective Scan in the Patient Information window. AutoScan AutoScan automatically performs a complete analysis of the patient data. After the automatic analysis is complete, you can re-label beats, review events, and select strips for inclusion in the final report. You are also prompted to review the templates and Profile. Select OK and the Profile will be displayed. Prospective Scan As an alternative, Prospective Scan will display an ECG at the start of the recording allowing you to review the beats in chronological order as you verify beat labels. You can add strips to the final report as you scan through the patient recording. Automatic Stop Criteria settings are user defined by checkbox selection. After selecting Prospective Scan the system requires a few seconds to load the patient data and the following screen is displayed.

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The Stop Event Criteria dialog determines events the system will stop on during a Prospective Scan. You

can select the desired Stop Event criteria before starting the scan and/or change it during the scan. The number displayed to the left of each Stop Event criterion is the total quantity that the system has

stopped on. The initial value for all events is zero. The event value will increase during the scanning only if it has been selected. The total number of events detected is available in the Profile display at the end of the scan.

The Pacemaker criteria and Atrial Fibrillation checkbox are not available if you did not select Patient

Has Pacemaker or Automatically Detect Atrial Fibrillation in the Patient Information dialog. You can select Superimposition Mode or Page Mode to begin the scan. A dialog window will show

your progress as you move through the recording. A screen displaying the ECG and Context view is shown each time an event matching the Stop Event criteria is detected or after a manual stop. To move backward and/or forward in time, use the Page Up and Page Down keys to display the previous

or following pages of the ECG. To select an event from the Context view, click on the desired event and it is displayed automatically in the ECG window on top of the screen. To move beat-by-beat, select a beat in the ECG display and use the (left) and (right) arrow keys on the numeric pad. When scanning is resumed, the system continues from the event where it last stopped.

The Scan Speed can be modified from Slow to Fast, or InstaPage in the Stop screen. To modify Stop Event criteria, select Change Stop Settings in the Stop screen or press F5 on the

keyboard. To continue or change to the Page Mode, click on Continue Page Mode or press F7 on the keyboard. To

continue or change to the Superimposition Mode, click on Continue Superimposition Mode or press F8 on the keyboard. You can switch from one mode to the other at any time.

To switch from Prospective Scan to Automatic Retrospective Analysis, select AutoScan to End or press

F12 on the keyboard. In this case, the system prompts you to confirm the choice.

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Learning Templates during Prospective Scans When the system stops on a New Morphology while performing a Prospective Scan, it is possible to re-label all beats matching the New Morphology and have the system Learn the new label. Label allows you to re-label only the selected beats, while Learn affects all beats matching the same morphology of the first beat of the template. When more than one beat is highlighted, learn options are disabled. The user must select the first beat of the template to have the system learn the corresponding morphology.

ECG Waveform Color Codes With the exception of Superimposition display, all templates and ECGs displayed during review are color coded. Color coding allows you to instantly verify identification of each beat.

Blue = Normal

Orange = Ventricular

Light Green = Artifact

Green = Ventricular paced beats

Light Blue = Supraventricular

Red = R on T

Fuchsia = Unknown*

Aqua = Atrial Fibrillation

* Beats that are color coded as fuchsia are unclassified by the H-Scribe Rx. These beats are included in the total QRS count and are treated as normal in calculations of HR and in R-to-R interval calculations.

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Alternate Displays

To view alternate displays, click on a tab, press the keyboard shortcut, or use the View pull-down menu.

Tab Keyboard Shortcut View Pull-Down Menu

Profile Alt + 1 Hourly Profile

Trend Alt + 2 Graphic Trends

Superimposition Alt + 3 Superimposition

Templates Alt + 4 Templates

ECG Alt + 5 ECG Window

Alt + 6 Report Preview

Alt + 7 Context View

Ctrl + S Split Any combination of displays can be used during an editing session to prepare a final report. Templates Display A template is a group of beats matching the same shape, or morphology, presented in descending order by beat count in each template. If present, Ventricular templates are presented first. Check that all templates are labeled correctly. This is important as all counts and selections are based on this labeling. TIPS: Scan through the beats in each template with the Tab key. Merge templates of similar shape into a single template. Press and hold the Ctrl key as you select

templates, right click and select Merge Templates from the Context menu. When a recording contains a high number of templates and you wish to re-label several as Artifact, left

click on the first template and choose Label All Following As Artifact. Keyboard right and left arrow keys allow you to move from template to template. To change a template label, left click to select the desired template then right click to view the Context menu. Shortcut keys can also be used. When a template is re-labeled, all the beats in the template are re-labeled at once and the template is moved to the appropriate group when you exit the function. To change several templates at one time, click and drag the mouse over the templates or press and hold the Ctrl key as you click on non-consecutive templates to highlight them. Choose your desired label. To move through multiple pages of templates, press the Page Down. Current page/number of pages for the template group is shown in the lower left corner of the display (e.g., Page 1/2). When finished reviewing Ventricular templates, select other template categories from the Format menu. Review template categories (Ventricular, Normal, Supraventricular, Paced and Artifact) then proceed to review events in the Profile display.

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Supraventricular Template Group Supraventricular templates are created by separating all early normal beats from Normal templates and displaying them in templates in the Supraventricular Template view. Re-labeling of a Normal, Ventricular, Paced, or Artifact template as Supraventricular is not allowed. Re-labeling of a Supraventricular template as any other type (i.e., Normal, Ventricular, Artifact, or Paced) is supported. Re-labeling a template as Normal will cause the H-Scribe Rx algorithm to use the current SVPB Prematurity Scan Criteria % to analyze the beats in that template for Supraventricular status. A Relabel Templates message will appear and you can choose to cancel or proceed. When re-labeling a Supraventricular, Ventricular, Paced, or Artifact template as Normal, the beats may be split into both a Normal template and a Supraventricular template. Supraventricular Calculation by Prematurity Percentage and Beat Labeling Logic: Supraventricular beats are identified and labeled according to the Scan Criteria default or user definition for SVPB Prematurity %. Prematurity Calculation: Supraventricular calculation is based on the RR intervals from the previous normal beats. Each beat is associated with the preceding RR intervals.

The next normal beat should have occurred at this point according to the previous RR intervals. Because this beat is more than 20% early, it is labeled Supraventricular (according to the Scan Criteria setting).

100% 100% 100% 70% 30%

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Profile Display Profile display offers a complete tabular summary of all events in an hour-by-hour format. Left click to select an event in a particular hour or a maximum event in any given category. The ECG will be displayed with the event highlighted by a yellow frame.

The first column shows Diary Events (or markers) automatically entered if the recorder event button was pressed during the recording. Editing and Adding Diary Events Diary Events can be accessed by selecting Edit -> Diary Entry List. You can add new entries, or edit/delete existing events. Diary entries can also be accessed from the Select Patient list after the recording has been acquired and before the recording is reviewed. Typically, clinicians will include the most extreme episode strips during the monitoring period in the final report (i.e., minimum HR, maximum HR, longest RR interval, etc.). The summary row at the bottom of the Profile display contains such episodes if present.

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The following events can be reviewed using the summary row in the Profile display: Event Description

Diary Automatic and/or manually entered events

Heart Rate Min 5-second and 5-minute minimum HRs

Bradycardia Episode Bradycardia that meets set Scan Criteria

Heart Rate Mean* 5-minute mean HRs

Heart Rate Max 5-second and 5-minute maximum HRs

Tachycardia Episode Tachycardia that meets set Scan Criteria

Short RR Shortest RR interval

Supraventricular Ectopy/Run Length = 1 Single SVPB

Supraventricular Ectopy/Run Length = 2 SVPB couplet (two consecutive SVPBs)

Supraventricular Ectopy/Run Length = 3+ SVPB run (three or more consecutive SVPBs)

Supraventricular Ectopy/Max Run Maximum or longest SVPB run

Supraventricular Ectopy/Total Total SVPB count

AFib % % of Atrial Fibrillation in the selected hour

Ventricular Ectopy/Run Length = 1 Single VE

Ventricular Ectopy/Run Length = 2 VE couplet (two consecutive VEs)

Ventricular Ectopy/Run Length = 3+ VE run (three or more consecutive VEs)

Ventricular Ectopy/Max Run Maximum or longest VE run

Ventricular Ectopy/R on T R wave on or near the previous T wave

Ventricular Ectopy/Total Total VE count

Pauses/Max RR Maximum or longest RR interval

Pauses/Total Maximum RR interval exceeding the Pause Criteria

RR Variance/rr50 %* % of beats with RR intervals differing 50 msec or > from previous

RR Variance/rms-SD ms* Root Mean Square Standard Deviation

RR Variance/M-SD Magid Standard Deviation

ST/ Dp ST depression

ST/ El ST elevation

Paced Beats/Atrial Atrial Paced beats

Paced Beats/Vent Ventricular Paced beats

Paced Beats/Capt Fail Capture failure (no QRS after pacer spike)

Paced Beats/Und-Sen Pacemaker Under-sense (pacer spike is early)

Paced Beats/Ovr-Sen Pacemaker Over-sense (longer RR interval)

* Values only. These events are not navigable and do not show strips when selected.

NOTE: The events detected by the system are based on the Scan Criteria settings and template labels.

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ECG Display Once the ECG is displayed, you can display 1, 2, 3, or 12 leads depending on the recorder type. Select leads by using the Lead icons on the toolbar.

Select the strip tool and a red box will follow the mouse pointer as it moves over the ECG waveform. Center the red box on the ECG episode and left click to add the strip to the final report.

Select the strip annotation from the drop-down list or enter free text. Check desired leads in the Edit Strip pop-up window. When the strip tool is selected, right click the mouse to stretch or shrink the strip. Each click will expand or shrink the strip.

A page strip in full-disclosure format can be selected for inclusion in the final report. Any page strip duration between 6 and 60 minutes can be entered, as well as three pre-defined values of 15, 30, or 60 minutes. Only one lead is printed in a page strip with the ability to choose which lead. The strip annotation is also user selectable in the Edit Page Strip dialog. If the profile strip is incorrect due to artifact or mislabeled beats, type A to label the entire episode as artifact then press the spacebar to display the next episode. An example to correct a maximum HR episode is shown below.

Type “A” for artifact then spacebar to the next strip

Correct Maximum HR – 112 BPM

Repeat this step until you reach the correct maximum HR strip. After the strip has been added, click on the Profile tab to return to the Profile display. Select the next episode such as minimum 5-second HR and so on.

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Labeling Beats in the ECG Display

To change the classification of a beat or group of beats, select the Label Beats icon on the toolbar. Move the yellow vertical frame over the beat then right click to select the desired label from the Label pop-up menu. Shortcut keys can be used to quickly re-label the beat without opening the pop-up menu. Shortcut Key Label Normal n Label Ventricular v Label Paced p Label Artifact (on/off) a Label Supraventricular s Label Atrial Fibrillation b Label R on T r Labeling Regions in the ECG Display If you want to re-label consecutive beats, click and drag to select the total number of beats you wish to change. Any changes you make are reflected automatically in the Profile display. This is particularly useful when you want to label regions of beats as Atrial Fibrillation or when there are long periods of artifact due to interference or intermittent lead disconnection. A beat that has been manually labeled as Artifact can be reverted back and forth to its original label by alternately applying the Artifact label. A beat that is labeled as Artifact by the system cannot be re-labeled.

TIP: To select multiple beats, click on a starting beat and move the cursor over the desired ending beat. Click while holding down the Shift key. This is especially convenient if the starting and ending beats are not on the same page. Additionally, you can alternately deselect/reselect any beats within a selected range (previously dragged/clicked by the user) of beats by clicking on that beat while holding down the Ctrl key. This can be useful when most but not all of the beats inside a range need to be re-labeled. To find the template associated with a particular beat, double click on the beat in the ECG display. The screen is updated with the Template display and the associated template is highlighted.

NOTE: When individual beats are re-labeled in the ECG display, a new template will be created for these beats and they will be removed from the original template.

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Using the Calipers in the ECG Display Select the Caliper tool and click first on the ECG location where you wish to begin a measurement, click again on the location where you wish to end the measurement. The red vertical lines measure the time interval and the yellow horizontal lines measure the amplitude. At least two beats must be within the red calipers to calculate HR. To use the same interval in a different location, press and hold the Ctrl key and then click on the next location you wish to evaluate.

ECG Grid To display or hide ECG grid, click on Grid in the Format pull-down menu or simultaneously press Ctrl+G. The grid is displayed according to the number of channels and seconds displayed: 1 channel up to 120 seconds, 2 channels up to 60 seconds, and 3 channels up to 10 seconds. Context View

Context view provides a detailed view of the beats surrounding the vicinity of the ECG display focal point. To select Context view, click on Context View in the View pull-down menu or use the keyboard shortcut Alt+7. Context view appears on the lower portion of the screen. Each row of the ECG is one minute in duration. The red frame in the Context view correlates to the same region in ECG view. Adjust the amount of the displayed data in the Context view by dragging the splitter bar that divides the ECG and Context views.

To view a different lead, click anywhere in the displayed Context view and choose Select Context View Leads from the View pull-down menu. Select the desired lead from the dialog box.

TIP: You can click a beat anywhere in the Context view display and all other displays are automatically refreshed to present that beat as the focal point.

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Interaction between Displays Displays are synchronized with each other so that simultaneous viewing of the same time is possible. Changes to lead selections and/or gain settings are applied to Superimposition, Template, and ECG display; changes to the currently displayed time are applied to Trend, Superimposition, and ECG display.

TIP: Select desired time in Trend display as a quick way to navigate to a particular time in the recording. The Superimposition and ECG screens will update automatically to match. You can also use Select Time from the Navigate pull-down menu.

When reviewing the ECG, display the template that a beat belongs to by double clicking on the beat of interest. Print Screen

To print the displayed ECG select the Print Screen icon on the toolbar, click on Print Screen in the Patient pull-down menu, or press CTRL+P on the keyboard. An example is shown below.

All beats are labeled with a single letter to indicate the type of beat:

Label Beat Type

V Ventricular

S Supraventricular

P Paced

B Atrial Fibrillation

R R on T

E Ventricular Escape

U Unknown

* Artifact

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Lead Fail Conditions Lead fail will only affect the HR value when certain combinations of leads are in fail. When both V1 and V5 leads are disconnected, beat detection is disabled during the period and the area is highlighted in light green indicating artifact.

During periods when beat detection is disabled, a 0 (zero) HR value will appear in all displays and printouts even though the displayed lead(s) may not be affected. The example below shows Lead II which is not directly affected by the combined V1 and V5 lead disconnection. This period of the recording cannot be reliably used for ECG interpretation.

Light green highlighting indicates this period in time cannot be reliably used for ECG interpretation.

HR: 0

Lead V5 disconnected

Lead V1 disconnected

HR: 0

ECG Lead II continuous

rhythm

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Lead(s) OFF Channels Showing

Flat Line Beat Detection

RA II Off LA III Off RL None Normal LL II Off V1 V1 Normal V3 V3 Normal V5 V5 Normal RA + LA All 12 leads Off RA + RL All 12 leads Off RA + V1 II, V1 Off RA + V3 II, V3 Off LA + RL All 12 Leads Off LA + LL I, II, III, aVR, aVL, aVF Off LA + V1 III, V1 Off LA + V3 III, V3 Off LA + V5 III, V5 Off RL + V1 V1 Normal RL + V4 V4 Normal RL + V5 V5 Normal LL + V1 II, V1 Off LL + V3 II, V3 Off LL + V5 II, V5 Off V1 + V3 V1, V3 Normal V1 + V5 V1, V5 Off V3 + V6 V3, V6 Normal

Lead Fail Table For 12-Lead ECG Recordings The Lead Fail table lists ECG channels that show a flat line when specified leads are disconnected. The table also shows when beat detection is turned off during periods of disconnect. Other channels affected by disconnected leads will display a change in waveform amplitude and/or configuration. When lead fail occurs, waveform data is recorded in a “safe mode.” Leads will be reconstructed as possible. Beat detection is disabled when a combination of V1, V5 and RA, LA, or LL disconnect occurs. Data can be reviewed for rhythm and duration purposes; however, H-Scribe disables automatic algorithm analysis for HR and ST segment determination.

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Trend Display Trend display provides a graphical overview of 5-minute measurements for most events over the entire recording period. Drag the mouse to position the red trend-line cursor to the desired time. The numbers next to the trend-line cursor represent measurements computed for that selected 5-minute period. Graphically, the average value is plotted by the blue line from left to right; maximum and minimum 5-second values, whenever applicable, are indicated by the vertical gray bars. A green dotted line indicates the zero reference for HR and ST. SVPB, VPB, VPB2, and VPB3+ trends show two values indicating BPM rate and peak BPM rate. To alternate between Arrhythmia trend and ST Segment Only trend, select Switch Trend Tables from the View pull-down menu. View events by moving the cursor to a point in the trend and then clicking on ECG view. Blank areas represent periods where no ECG data exists.

ST II ST measurements Lead II

ST V5 ST measurements Lead V5

SVPB Supraventricular premature beats inclusive of singles, couplets, and runs

VPB Ventricular premature beats, single

VPB2 Ventricular premature beats, couplets

VPB3+ Ventricular premature beats, runs

HR Heart rate

RR RR interval

Std RR variance (standard deviation)

NOTE: H3+ recordings will display ST I, ST II, ST V, or ST C1 and ST C2 for ST segment trending

Trend Line Cursor

Selected Time

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Superimposition Display Superimposition display is useful for identifying beat morphology changes. By separating and overlaying beats at rapid speeds, you can identify changes in ECG waveform, especially P waves, ST changes, and other low-voltage components that can be overlooked in full-disclosure presentations. Beats are separated into two categories. Normally conducted beats are displayed on the left (blue); ventricular beats are displayed on the right (orange).

The time displayed in the upper left corner corresponds to the time of the last superimposed beat. The duration of the superimposed complex is one minute. At any time you can choose to pause/resume or stop, change the speed/direction, jump to the previous/next hour, or jump to the beginning/end of the recording. Use the toolbar or the Format pull-down menu to increase/decrease the number of leads displayed.

Pause/Resume

Jump to Beginning

Stop

Jump to End

Play Backwards

Next Hour

Previous Hour

Normal Ventricular

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Split Screen View

Split screen view provides simultaneous viewing of Profile and ECG, Trend and ECG, Superimposition and ECG, or Templates and ECG displays. To select split screen view, click on Split in the View pull-down menu or use the keyboard shortcut Ctrl+S. Split screen view displays the selected Profile, Trend, Superimposition, or Templates display on the left side of the screen and the ECG display on the right side.

To adjust the width of any half of the display, drag the vertical splitter bar dividing the halves to a new location.

Strip List Review

You can add or delete automatic ECG strips prior to selection of report preview. Select Edit and then Strip List. Click the Add Auto-Strips button to add automatic strips according to settings you defined in the Report Options dialog.

Click the column header to sort by Time, Strip Annotation, Duration, or Leads. Strip annotations can be edited, and strips can be moved up, down, or deleted.

Select OK when finished to save your changes.

Final Reports

Report Preview

Select the Report Preview icon from the toolbar or select Report Preview from the View pull-down menu. The display changes to a Windows print preview showing the summary page of the final report.

Several button selections are available to view the pages of the final report. Print allows you to print the final report to your Windows printer. Export Report, if enabled, allows you to export the final report to a predefined destination. Report Options allows you to customize the final report.

Report Headers

The report header, located at the top of the summary page, includes user-configurable information for a given facility. Change to a different header by choosing from the Line 1: drop down, or create a new header through selection of the Add button. Remove a report header by using the Delete button. Click OK to save your changes.

Report Options

In addition to the summary page, you have the option to add or remove a copy of the Profile table, episodes and/or trends, user-selected ECG strips, and full disclosure. To modify the final report, click on Report Options on the toolbar at the top of the Report Preview screen. The system displays a dialog box with the following selections:.

Sections of the Summary Page, additional pages, and Full Disclosure can be selected or removed by checkbox selection.

Template Pages will print when checked for the appropriate template group. Desired leads are also selected by checkbox.

When Adding Automatic Strips, select the checkboxes for your desired leads. The Add Auto-Strips button will automatically add the strips according to your selections. (This option is also available through the Strip List dialog.)

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Automatic strips include: o Min/Max HR o Longest/Fastest Tachycardia Episode o Longest/Slowest Bradycardia Episode o Longest/Fastest Ventricular Run o Longest/Fastest Supraventricular Run o Longest RR interval o Periodic Strips when checked

Periodic Auto-Strips can be selected. The first strip Offset From Start time is set with HH:MM:SS for

each following strip. When Skip Lead Fail is selected, any strip that has lead fail will be excluded. Save as Default will save your report selections as a default for all future scans; Load Defaults will load

these selections for any other patient recording. Selecting Hours for Full Disclosure Select Report Options on the toolbar at the top of the Report Preview screen, then click on Select Hours to the right of desired Full Disclosure Lead option. Select the hours you want to include in the final report by clicking the checkbox to the left of the desired hours, then select OK. You can also choose Select All to include full disclosure for all recorded hours. Selecting None will remove all selections; Cancel will cancel all your changes and close the window. Select OK to save your changes and exit from the Report Options dialog box. To print the final report, select Print from the menu bar and then OK. Override Selection of Override allows you to override measurements reported on the summary page of the final report. Change any of the values in the window and/or add free text, acronyms, or comments, then click OK. Cancel will cancel all your changes and close the window; Restore will replace your changes with the original values. Acronyms To add a new acronym, click on Edit Acronyms from the Edit Summary Report screen. Click in the empty acronym edit field and type the desired acronym (e.g., AFib), then click in the empty acronym text edit field and enter the word or phrase associated with that acronym (e.g., atrial fibrillation). Click Add. The new acronym and acronym text is displayed in the acronym list. Click OK to return to the Edit Summary Report screen. To edit or update an existing acronym, select the acronym from the list with a double click, or highlight and select Edit. Both the acronym and its associated text are displayed in their respective fields. Make the desired modifications and click Update. To delete an acronym, select the acronym and click Delete. Click OK to return to the Edit Summary Report screen.

NOTE: You can also access the Edit Acronyms screen by selecting Quick Lists and Acronyms in the Edit pull-down menu.

NOTE: Acronyms may only contain letters and numbers and may not contain spaces. Acronym text may contain spaces.

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To enter comments, click in the comment window and type free text. To use a predefined acronym(s), choose any one of the following methods.

Double click on the acronym. Highlight the acronym and click on Copy to Comment. Type a forward slash (/) and the acronym. The corresponding text is replaced when you select

Replace Acronyms.

NOTE: Acronyms are matched and replaced in a case-insensitive manner. AMI is the same as ami.

NOTE: If you do not select Replace Acronyms, the acronym text is displayed automatically on the final report.

Closing the Patient Recording

On exiting the review, a dialog box prompts you to confirm if the patient record should be marked as reviewed.

You can also access the review prompt by selecting Open Patient on the toolbar before you exit.

Click on Yes to mark the patient record as reviewed. A message will then appear informing you to wait while the Audit Trail PDF file is being created and saved. If you press the ESC key, no Audit Trail record will be saved. The status column on the Select Patient screen is updated with an R status informing all users that editing and review of this patient recording is complete.

If No is selected you will be returned to the Select Patient list with no change in the patient’s recording status.

48-Hour Recordings

When a 48-hour digital recorder is used, data is acquired in a manner similar to a 24-hour recording; however, the following will apply:

In the lower portion of the Patient Information window you will select 24 or 48 Hour Recording prior to choosing the scan mode. This allows you to choose 24 hours if a longer recording period was not intended.

The first 24-hours of data is referred to as “24 Hour Period 1”; the second 24 hours will be referred to as “24 Hour Period 2.” Both periods are stored in the same patient slot.

The entire 48 hours of recorded data will be acquired at one time. You will be required to enter patient information only once. Each time the first 24-hour period is opened and closed, you will be prompted to review the second 24-hour period.

After choosing Yes or No, you will be prompted to “Mark as Reviewed?”

With any rescan, changes will apply to both 24-hour periods.

Use of Delete Patient, Archive, or Restore affects both 24-hour periods. Reviewing, Exporting, and Printing the 48-Hour Final Report

The 48-hour summary page is only available when you preview and print 24 Hour Period 2. Any changes made to the period 1 recording are reflected in the summary that is part of the period 2 preview and printout. When the final report is exported, the period 1 and period 2 pages will be interleaved; the PDF report output will be a single PDF file.

When you print a hard copy of the 48-hour final report, you will need to print both periods 1 and 2 and interleave the pages manually.

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Pull-Down Menus Pull-down menus are located at the top of the screen. The availability of some menus will vary according to the displayed screen.

Patient Pull-Down Menu

COMMAND FUNCTION

Open Patient Closes existing patient record and displays Select Patient list.

Patient Info View or edit current patient information.

Rescan Re-analyze current patient.

Export XML… Open XML export dialog window.

Export to E-Scribe Open Unipro ECG export dialog window.

Print Screen Print current screen. Choose number of copies, pages to be printed, destination printer, and orientation of job to be printed. NOTE: Print screen applies to ECG display only.

Print Preview Preview what is to be printed. NOTE: Print preview applies to report preview only.

Print Setup Set print properties including destination printer and page orientation.

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Edit Pull-Down Menu

COMMAND FUNCTION

Strip List Edit annotations and lead selection; remove or change order in which strips are included in final report; add automatic strips.

Scan Criteria View or change Scan Criteria. These settings are used in conjunction with the H-Scribe Rx analysis program to customize event detection for a particular patient. Once changed, settings remain in effect for this patient until modified. Most changes take effect immediately; changes to SVPB Prematurity % require a rescan.

Report Header Specify up to a four-line report header to be included with the final report. The report header is displayed at the top of each final report. It is recommended to include name, address, city, state, zip code, and phone number of scanning location. Once set, the H-Scribe Rx retains information until modified.

User Profiles Add a new user profile or view, change, delete, or rename current user profile. Includes these default settings: Select Patient screen, display modes, language, and Prospective Scan parameters. Once changed, user profile remains in effect until modified.

Quick Lists

Quick Lists speed data entry and are available in the following fields:

–Strip Annotation

–Diary Annotation

–Referring Physician

–Reviewing Physician

–Indication

–Medication

–Hookup Tech

–Analyst

–Acronym

TIP: For very long lists, type the first letter of the list item to quickly move to that location.

Strip Annotation: Create a list of commonly used strip annotations during event selection and labeling. Available to configure lists during event selection.

Diary Annotation: Create a list of commonly used diary annotations during event selection and labeling. Available in Patient Info screen and to configure lists during event selection.

Referring Physician: Create a list of physicians who most frequently refer patients for Holter analysis. Available in Patient Info screen.

Reviewing Physician: Create a list of physicians who most frequently review patients for Holter results. Available in Patient Info screen.

Indication: Create a list of symptoms related to Holter requests. Available in Patient Info screen.

Medication: Create a list of common medications. Available in Patient Info screen.

Hookup Tech: Create a list of hookup technicians. Available in Patient Info screen.

Analyst: Create a list of analysts. Available in Patient Info screen.

Acronym: Create a list of acronyms to be accessible in the comment section of the final report.

Diary Entry List Add, edit, or remove diary entries in the current diary list. Events are available for selection in the Diary column of the Profile display. The system retains a maximum of 120 diary entries.

ST: Edit Event Edit an ST event to change the ST information included in the final report.

NOTE: If an ST event is not currently selected in the Profile display, function is not available.

ST: Remove Event Remove an ST event from the final report.

NOTE: If an ST event is not currently selected in the Profile display, function is not available.

ST: Restore All Events Restore all ST events to be the same as what was originally analyzed by system.

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Navigate Pull-Down Menu

COMMAND FUNCTION

Next Page Move to next page.

Prev Page Move to previous page.

Next Line Move to next line.

Prev Line Move to previous line.

Next Second Move to next second.

Previous Second Move to previous second.

First Page Move to first page.

Last Page Move to last page.

Select Time Navigate to an exact time in the analysis period. Time is presented in a 24-hour format and is selectable to a given second.

Next Event Navigate all displays to next event in the selected field. Example: If you are sampling Ventricular Runs and more examples are required, Next Event advances to next example of Ventricular Runs.

Prev Event Navigate all displays to previous event in the selected field. Example: If you are sampling Ventricular Runs and more examples are required, Prev Event advances to last example displayed of Ventricular Runs.

Label Pull-Down Menu

COMMAND FUNCTION

Normal Label selected beat or template Normal (blue shade box). (N key on keyboard.)

Ventricular Label selected beat or template Ventricular (orange shade box). (V key on keyboard.)

Paced Label selected beat or template Paced (dark green shade box). (P key on keyboard.)

Artifact (on/off) Label selected beat or template Artifact (green shade box). (A key on keyboard.)

Supraventricular Label selected beat Supraventricular (light blue shade box). (S key on keyboard.)

Atrial Fibrillation Label selected beat A-fib (aqua shade box). (B key on keyboard.)

R on T Label selected beat R on T (red shade box). (R key on keyboard.)

Learn Normal Instruct system to learn as Normal. (Ctl+Shift+N key combination.)

NOTE: Only available in Prospective Scan.

Learn Ventricular Instruct system to learn as Ventricular. (Ctl+Shift+V key combination.)

NOTE: Only available in Prospective Scan.

Learn Paced Instruct system to learn as Paced. (Ctl+Shift+P key combination.)

NOTE: Only available in Prospective Scan.

Learn Artifact Instruct system to learn as Artifact. (Ctl+Shift+A key combination.)

NOTE: Only available in Prospective Scan.

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Format Pull-Down Menu

COMMAND FUNCTION

Number of Leads Select number of leads for display and printing. For CF memory card acquisition, available options are 1, 2, 3, and 12 leads. For cassette tape acquisition, available options are 1, 2, and 3 channels.

Select Lead If less than three leads are selected, choose which of the three full-disclosure leads are presented. For CF memory card acquisition, available options are Leads II, V1, and V5.

For H3+ 2-channel acquisition, available options are channels C1 and C2. NOTE: Only available in 1 or 2-lead display modes.

For H3+ 3-channel acquisition, available options are leads I, II, and V. If alternate leads are selected, available options are channels C1, C2, and C3. NOTE: Only available in 1, 2, or 3-lead display modes.

Gain Increase or decrease the amplitude of displayed complexes. The available options are ½, 1, 2, or 4 times the original size.

Timespan or Zoom Increase or decrease time span on the display based on number of leads selected. Available options are:

–Single Lead: 15, 30, 60, 120, 180, 300, 600, 1200, or 1800 seconds –Two leads: 7.5, 15, 30, 60, 90, 150, 300, 600, or 900 seconds –Three leads: 5, 10, 20, 40, 60, 100, 200, 400, or 600 seconds

Use center wheel on mouse or + and - keys on numeric keypad for zooming.

NOTE: Only available in 1, 2, or 3-lead display modes.

Grid Select to turn grid on in ECG display; deselect to turn grid off. (Ctrl+G key combination.)

The grid will be displayed when the following leads/seconds are selected:

Single Lead: 15, 30, 60, or 120 seconds Two Leads: 7.5, 15, 30, or 60 seconds Three Leads: 5 or 10 seconds

Merge Templates Is active when more than one template is selected. Click and drag mouse over desired templates or press and hold Ctrl key as you select desired templates. You can also use Ctrl+M key combination or the template label pop-up menu that opens when you right click.

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Tools Pull-Down Menu

COMMAND FUNCTION

Select Strip Choose Select Strip to display a red frame on the screen. Initially, frame is 7.5 seconds (4 seconds for 12-lead, 6+6 mode). Size frame by using the right and left arrow keys on numeric keypad, or by right clicking and selecting Stretch or Shrink from the pop-up menu. Select an event for the final report and click in red frame to insert custom annotation, or choose annotation from the pull-down list. Select leads to be included with the strip.

Caliper Choose Caliper to display a cross-hair on the screen. Select area to be measured by clicking the first point and moving to and clicking on the second point. Measurement display in the upper right corner indicates time span, HR, and amplitude in reference to the selected point. To use the same selected point but at a different time, hold down the Ctrl key and click. If you select Print Screen in this mode, measurements are included at the bottom of the printed page.

Label Beats With the Label Beats tool, right clicking the beat displays a menu of possible label selections. Highlight the beat and right click on desired label; selected beat changes to the type chosen. If more than one successive beat is to be given the same label, drag a left mouse click to select a range of beats. Use a right mouse click as described above.

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View Pull-Down Menu

Command Function

Hourly Profile Selects Profile display.

Graphic Trends Selects Trend display.

Superimposition Selects Superimposition display.

Templates Selecs Template display.

ECG Window Selects ECG display.

Report Preview In Report Preview display, view onscreen all current pages of the final report. Current pages include: summary, profile, trends, ST episodes, strip list, strips, and full disclosure. Select Report Options to select which pages are printed. Edit the summary page by selecting the Report Options display and then use override.

Context View In Context view, used in conjunction with ECG display, you view onscreen the ECG in the context of the surrounding beats. Initially, window includes 3 minutes of ECG but may be sized larger. Function is extremely helpful in correlating arrhythmias to diary entries.

Split In the Split view, used in conjunction with ECG display, you view onscreen a split format: Profile/ECG, Trend/ECG, Superimposition/ECG, or Templates/ECG. In Split view, all displays function in the same manner enabling you to sample events while viewing profile, superimposition, templates, and so forth.

Select Context View Leads

Select Context View Leads to select a different lead for the Context view.

NOTE: Any changes made persist only until you open next patient. To permanently change Context View lead, refer to Context View in this section.

Switch Trend Tables Select Switch Trend Tables view to alternate between arrhythmia trends and ST segment trends only.

Help Left-click on Help to display About menu. Left-click on About to display H-Scribe Rx enabled features, current software version, and dongle serial number. About in Select Patient display will show the same information.

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Icons

Glossary of Icons

ICON FUNCTION

Open Patient Closes existing patient record and displays Select Patient list.

Report Preview Select Report Preview.

Print Screen Print current screen. Choose number of copies, pages to be printed, destination printer, and orientation of job to be printed.

NOTE: Print screen applies to ECG display only.

Lead II

Lead I

Channel c1

Select Lead II for display and printing H12+ recordings. Select Lead I for display and printing H3+ 3-CH recordings. Select channel c1 for display and printing H3+ recordings.

Lead VI

Lead II

channel c2

Select Lead V1 for display and printing H12+ recordings. Select Lead II for display and printing H3+ 3-CH recordings. Select channel c2 for display and printing H3+ recordings.

Lead V5

Lead V

channel c3

Select Lead V5 for display and printing H12+ recordings. Select Lead V for display and printing H3+ 3-CH recordings. Select channel c3 for display and printing H3+ recordings.

12 Lead

not available

Display the 12-lead ECG at the current time. (Ctrl+1 for 12 x 1 mode; Ctrl+6 for 6+6 mode.)

12-lead is not available for H3+ recordings.

Gain Increase or decrease amplitude of ECG for display and printing.

Arrow Left Display previous page of ECG, or select previous template.

Arrow Right Display next page of ECG, or select next template.

Previous Event Display previous event in current category.

Next Event Display next event in current category.

Label Beat Select Label Beats as current tool.

Caliper Select Caliper as current tool.

Select Strip Select Select Strip as current tool.

Timespan or Zoom Change Timespan or Zoom of the ECG for display.

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FINAL REPORTS SECTION 5

39

Summary Page The summary page consists of a report header, patient information, scan criteria, and summary statistics. (Summary statistics may require a second page if lengthy comments have been added. A maximum of two pages are allowed for the summary statistics and comments.) The report header, located at the top of page one, includes user-configurable information for a given facility. The report header can be customized in Report Preview mode or by selecting Report Header in the Edit pull-down menu. Multiple selections can be created by using the Add button; selections can be removed by using Delete. The report header can be changed by choosing from the Line 1 drop-down list. The H-Scribe Rx software version that was used for the analysis is shown in the bottom right corner of the summary page as Reviewed by Ver. X.XX. Scanned by Ver. X.XX / Reviewed by Ver. X.XX will be shown in this area when a different software version was used for the analysis. The patient information section contains both patient information as well as important general information including recorder number and software version, hookup technician, and analyst. This information is accessible and may be modified outside of Report Preview mode by selecting Patient Info in the Patient pull-down menu. The scan criteria section includes settings utilized for the analysis of this recording. This information is specified in the Scan Criteria dialog, and is always included as part of the summary page. The summary statistics section includes different entries and text statements depending on what was selected in the Report Options dialog. The section may include a Tabular summary, a Narrative summary, or ST and RR variability measurements. Entries included in the Tabular summary and their definitions are shown on the following pages. Rate statistics are always included as part of the Tabular summary.

Rate Statistics ENTRY DEFINITION

Min Rate Minimum HR (BPM) recorded over a 5-second interval at HH:MM:SS time.

Max Rate Maximum HR (BPM) including Ventricular beats recorded over a 5-second interval at HH:MM:SS time.

Mean Rate Mean HR (BPM) computed over the entire monitoring period.

Total QRS Total number of detected QRS complexes including both normal and Ventricular beats.

Monitoring Period HH hr, MM min total time monitored.

NOTE: Narrative summary includes maximum ST depression and ST elevation values detected for all leads when include ST information has been enabled in the Report Options dialog.

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The Supraventricular Ectopy section has the following definitions. This section is always included with the Tabular summary although lines for Atrial Fibrillation and fastest and longest run are included only if episodes are detected.

Supraventricular Ectopy

ENTRY DEFINITION

AFib (Time %)/ peak avg. rate

When detected, % of time that Atrial Fibrillation was present during monitoring period and peak average rate during Atrial Fibrillation (BPM).

Singles Number of occurrences of a single Supraventricular Ectopic beat during monitoring period.

Couplets Number of occurrences of two consecutive Supraventricular Ectopic beats during monitoring period.

Runs Number of occurrences of three or more consecutive Supraventricular Ectopic beats during monitoring period.

Fastest Run Fastest HR (BPM) measured over Supraventricular Runs at HH:MM:SS.

Longest Run Longest Supraventricular Run (number of beats) measured at HH:MM:SS.

Total Total number of Supraventricular Ectopic beats during monitoring period.

The Ventricular Ectopy section has the following definitions. This section is always included with the Tabular summary although lines for Ventricular Paced beats and fastest and longest run are included only if episodes are detected.

Ventricular Ectopy

ENTRY DEFINITION

Vent Paced (Time%) / Beats

When pacemaker present, % of time Ventricular Pacing was active during monitoring period and how many beats were paced.

Singles Number of occurrences of a single Ventricular Ectopic beat during monitoring period.

Couplets Number of occurrences of two consecutive Ventricular Ectopic beats during monitoring period.

Runs Number of occurrences of three or more consecutive Ventricular Ectopic beats during monitoring period.

Fastest Run Fastest HR (BPM) measured over Ventricular Runs at HH:MM:SS.

Longest Run Longest Ventricular Run (number of beats) measured at HH:MM:SS.

R on T Number of occurrences of an R wave detected on the T wave of preceding beat.

Total Total number of Ventricular Ectopic beats during monitoring period.

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The RR Variability section has the following definitions. This section is only included in the Tabular or Narrative summary if Include RR Variability Information is selected in the Report Options dialog.

RR Variability

ENTRY DEFINITION

%RR>50 Percentage of successive RR intervals with greater than 50 ms difference between normal beats.

rms-SD Root-mean-square of successive differences of the RR intervals (ms) between normal beats.

Magid SD Magid standard deviation of the RR intervals (ms) for each 5-minute segment. Conventionally referred to as SDNN index.

Kleiger SD Kleiger standard deviation of the RR intervals (ms) over a 24-hour period.

Both the Magid (also known as SDNN index for standard deviation normal to normal) and Kleiger are standard measures of time-domain HR variability. Kleiger1 is the standard deviation of all normal RR intervals observed over a 24-hour monitoring period. A single value is presented on the final report summary page. Magid calculates the standard deviation of the normal RR intervals averaged over five-minute intervals during the monitoring period. Hourly values and a 24-hour total value are presented in the final report. The ST Deviation section has the following definitions. All ST segment measurements are based on averages over five-minute intervals. This section is only included in the Tabular summary if Include ST Information is selected in the Report Options dialog.

ST Deviation

ENTRY DEFINITION

Max Depression (V) Maximum ST segment depression in microvolts (1 mm = 100 microvolts) on V1/I/C1 and V5/V/C2 at HH:MM:SS time.

Max Elevation (V) Maximum ST segment elevation measured in microvolts (1 mm = 100 microvolts) on V1/I/C1 and V5/V/C2 at HH:MM:SS time.

The Tachycardia/Bradycardia section has the following definitions.

Tachycardia/Bradycardia

ENTRY DEFINITION

Longest Tachycardia Longest Tachycardia Episode duration (HH:MM:SS), average BPM and start time (HH:MM:SS) that meets Scan Criteria settings.

Fastest Tachycardia Fastest Tachycardia Episode duration (HH:MM:SS), average BPM and start time (HH:MM:SS) that meets Scan Criteria settings.

Longest Bradycardia Longest Bradycardia Episode duration (HH:MM:SS), average BPM and start time (HH:MM:SS) that meets Scan Criteria settings.

Slowest Bradycardia Slowest Bradycardia Episode duration (HH:MM:SS), average BPM and start time (HH:MM:SS) that meets Scan Criteria settings.

1 R.E. Kleiger, J.P. Miller, J.T. Bigger Jr., et. al. Decreased Heart Rate Variability and Its Association with Increased Mortality after Acute Myocardial Infarction. American Journal of Cardiology 1987;959:256-262.

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The Pauses section has the following definitions. The number of pauses are only included if detected RR intervals are greater than the defined Scan Criteria.

Pauses

ENTRY DEFINITION

Longest RR Longest RR interval (seconds) observed at HH:MM:SS time. Can include or exclude RR intervals between Ectopic and normal beats according to the Scan Criteria.

# RRs > 2.0 sec Number of RR intervals with duration greater than pause threshold set in Scan Criteria (2.0 second as a default). Can include or exclude RR intervals between Ectopic and normal beats according to the Scan Criteria.

If Narrative summary is selected in the Report Options dialog, a narrative report is included. This can be used in addition to a Tabular summary or as a substitute. The filled in Narrative summary includes the following statements with the appropriate entries from the Tabular summary as shown below.

Narrative Phrases

ENTRY STATEMENT

Start Time/Duration (always included)

Monitoring started at <Start Time> and continued for <Duration>.

Rate Statistics (always included)

Average HR was <Mean Heart Rate> BPM, with minimum rate <Minimum Heart Rate> BPM occurring at <Minimum Heart Rate Time>, and maximum rate <Maximum Heart Rate> BPM occurring at < Maximum Heart Rate Time>.

Longest Tachycardia Episode (included only if Tachycardia is detected)

Longest episode of Tachycardia was detected with an onset at <Time>, a duration of <HH:MM:SS>, and an average HR of <beats per minute>.

Fastest Tachycardia Episode (included only if Tachycardia is detected)

Fastest episode of Tachycardia was detected with an onset at <Time>, a duration of <HH:MM:SS>, and an average HR of <beats per minute>.

Longest Bradycardia Episode (included only if Bradycardia is detected)

Longest episode of Bradycardia was detected with an onset at <Time>, a duration of <HH:MM:SS>, and an average HR of <beats per minute>.

Slowest Bradycardia Episode (included only if Bradycardia is detected)

Slowest episode of Bradycardia was detected with an onset at <Time>, a duration of <HH:MM:SS>, and an average HR of <beats per minute>.

Atrial Fibrillation (included only if detected)

Atrial Fibrillation was detected for <Time>% of the monitoring period, and the peak average rate during Atrial Fibrillation was <Rate> BPM.

Supraventricular Ectopy (always included)

Supraventricular Ectopic activity consisted of <Total> beats, which included <Singles> single beats, <Couplets> couplets, and <Runs> runs of 3 beats or longer.

Supraventricular runs (included only if runs are detected)

Fastest Supraventricular run had a rate of <Fastest Run> BPM and occurred at <Fastest Run Time>. Longest run was <Longest Run> beats long and occurred at <Longest Run Time>.

Ventricular paced beats (included only if Pacemaker Analysis is enabled)

Ventricular pacing was detected for <Time>% of the monitoring period, and number of ventricular paced beats was <Total>.

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Narrative Phrases

ENTRY STATEMENT

Ventricular Ectopy (always included)

Ventricular Ectopic activity consisted of <Total> beats, which included <Singles> single beats, <Couplets> couplets, <R on T> R on T events, and <Runs> runs of 3 beats or longer.

Ventricular runs (included only if runs are detected)

Fastest Ventricular run had a rate of <Fastest Run> BPM and occurred at <Fastest Run Time>. Longest run was <Longest Run> beats long and occurred at <Longest Run Time>.

Pauses (always included)

Longest RR interval was <Longest RR> sec at <Longest RR Time>, with <# RRs > Pause Time.> RRs longer than <Pause Time> sec.

RR Variability (included only if selected)

RR variability measures were: RR-50 of <%RR>50>%, rms-SD of <rms-SD> ms, Magid SD of <Magid-SD> ms, and Kleiger SD of <Kleiger-SD> ms.

ST Deviation (included only if selected)

Maximum ST depression of <Max Depression> uV was detected in lead < Max Depression Lead> at < Max Depression Time>, and the maximum ST elevation of < Max Elevation > uV was detected in lead < Max Elevation Lead > at < Max Elevation Time >.

Profile Page

When selected in the Report Options dialog, the Profile page is included as part of the final report and provides an hour-by-hour Rhythm Profile to include a summary of HR, Ventricular Ectopy, and Supraventricular Ectopy in the top section of the page. The bottom section includes the HR with Tachycardia and Bradycardia beat counts and percentages, pauses, RR variances (whether or not Include RR Variability Information was selected in the Report Options dialog), as well as paced beats (whether or not patient is indicated as a pacemaker patient) from the Profile page.

NOTE: Tachycardia and Bradycardia beat counts and percentages are calculated for every 5-second interval. Tachy and Brady calculations in this section are not dependent on the Scan Criteria episode duration.

When any ST episodes (depression or elevation) are noted in the Profile page, they are included in the final report as a separate table, with the event onsets and end as shown below. This table is included if the Profile Page checkbox is checked but independent of whether or not Include ST Information was selected in the Report Options dialog.

When any Tachycardia or Bradycardia episodes (exceeding the settings in Scan Criteria) are noted in the Profile page, they are included in the final report as a separate table, with the event onset, end, duration, max (or min for Bradycardia) HR, average HR of the entire episode, and total number of QRS during the episodes.

NOTE: Periods of artifact that occur within a Tachy/Brady episode will be considered to have the same HR and will be included in the duration of the episode.

Trend Page

Selecting Trend Page in the Report Options dialog includes the Trend page as part of the final report. Trend page includes all trends for leads V1, V2, V3, V4, V5, V6, aVL, I, II, aVF, and III independent of whether or not Include ST Information or Include RR Variability Information were selected in the Report Options dialog.

In addition to ST segment trends, information for Supraventricular and Ventricular Ectopy, HR, and RR intervals is also trended.

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Strip Pages All automatic and user-selected strips are included in the final report when Strip Pages is selected in the Report Options dialog. The strips are preceded by a Table of Examples page listing Strip Annotation, Time of strip; Leads the strip includes, and Page of the final report where the ECG waveform can be located. The strips themselves are included with strip annotation, beat labels, timestamp, and reference grid. A 12-lead strip may also be included in the final report. A Page strip can also be included in the final report. The Page strip is similar to full disclosure, but can be set to include user-defined intervals of time (from 6 to 60-minutes of a single lead per page) when using the Strip Selection tool. Time and amplitude scale are indicated in the upper left-hand corner and average HR for each line of waveform is displayed in the left margin of page strips and full disclosure pages.

48-Hour Recordings When acquiring data for a 48-hour recording, two separate final reports--one for each 24-hour period--will be generated when a print is selected. All pages of the final report will indicate one of the following: 24 Hour Period #1 of 2, or 24 Hour Period #2 of 2. NOTES: A rescan, change of Scan Criteria, change of patient information (including demographics, AFib

detection, or pacemaker detection) will affect both 24-hour periods. The two final reports must be printed individually. Open each 24-hour period separately and print

each period by selecting Print Report in the Report Preview screen. The 48-hour summary page will only print together with the 24 Hour Period#2 of 2.

When the 48-hour final report PDF is exported electronically, Period 1 and Period 2 pages will be interleaved and the PDF report output will be a single PDF file.

When the 48-hour final report XML is exported electronically, Period 1 and Period 2 will be a single XML file.

INTERFACE EXPORT SECTION 6

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Introduction Interface Export allows you to digitally export Holter data statistics in XML format, along with the entire final report in PDF format. This feature enables connectivity to other devices and allows development of an interface for these devices to accept information from H-Scribe Rx. Interface Export Statistics include:

Patient demographics and recording time Scan criteria Summary statistics from the first page of the final report Comment and Narrative summary All information from the second page of the final report (hour-by-hour statistics) List of all ST episodes List of all diary entries

Interface Export Setup and Data Export The path for all exported XML and PDF files is controlled by the file Interface.dir located in the root patient directory of the Patient List whose data you are reviewing. Refer to Section 11 for details about Interface Export setup. Interface Export is controlled by selecting one of two checkboxes in the User Profiles dialog. It is possible to select both; however, doing so will result in two exports of the same patient recording. 1. Include when Exporting Report 2. Automatic when marked as Reviewed Verify that Interface Export is sending data to the proper location: If Include when Exporting Report has been selected in the User Profile

o Open a patient record o Select Report Preview Print icon from toolbar o Select Export Report

If Automatic when marked as Reviewed has been selected in the User Profile

o Open a patient record o Exit patient record o Select Yes when prompted “Do you want to mark as Reviewed?”

Before exporting Rx XML data it is recommended that the patient record be reviewed and edited to ensure its accuracy. After the data has been exported in this manner, a status flag ‘X’ appears in the Select Patient screen and a text file is automatically saved in the patient directory.

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Interface Export File Name and Structure

The filename for each Interface Export XML file is constructed as:

H^<type>_<patientlist>^<slot#>_<id>^<lname>^<fname>^<mname>_<starttime>_<exporttime>.xml

<type> = “STAT” for statistics <patientlist> = patient list name <slot#> = slot number on the workstation <id> = patient’s ID <lname> = patient’s last name <fname> = patient’s first name <mname> = patient’s middle name <starttime> = acquisition time of first sample to nearest second in the format YYYYMMDDHHMMSS <exporttime> = time statistics was exported in the format YYYYMMDDHHMMSS

Example of a statistics XML filename: H^STAT_Local Computer^1_123456789^Smith^John_20031216104632_20040318153145.xml

Example of a PDF report filename: H^REPORT_Local Computer^1_123456789^Smith^John_20031216104632_20040318153145.pdf NOTES: The patient list name, ID, first name, and last name will have all illegal characters replaced with a dash

‘-‘. The following characters will be replaced: * ? < > | “ / \ : # _ ^.

PDF filename length is limited to 255 characters when PDFLib (in H-Scribe Rx software) is used.

PDF filename length is limited to 125 characters when Adobe Acrobat PDF Writer is used. PDF Writer was included with earlier H-Scribe Rx systems as a component of the web browser option.

Interface Exported Status Files

Once the patient record has been exported, a status text file named ReportExported.txt will be created (or appended to) in the patient directory listing what was exported and when. A line will be added to this file each time data is exported.

Interface Export and H-Scribe Rx Custom ID

The Interface Export feature will export all demographics using the default assumptions for the meaning of each field regardless of any custom ID that might be in use. In support of custom ID, additional demographics will be exported with the labels from the current custom ID.

Examples: <DEMOGRAPHIC_FIELD NAME="INDICATIONS" LABEL="Indications" VALUE="Syncope" /> <DEMOGRAPHIC_FIELD NAME="MEDICATIONS" LABEL="Medications" VALUE="PROPAFENONE" />

If it exists, custom ID will appear in the black text after “LABEL=”. The examples above are not customized.

Interface Export Schema File

Each export includes an XML schema file that can be used by external programs to validate the XML output. The HolterStatistics_V5.dtd schema file is installed in the C:\Program Files\Mortara Instrument Inc\H-Scribe\XML directory. This file is automatically copied to the destination folder where the Interface XML exported files are sent.

RX XML EXPORT SECTION 7

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Introduction Rx XML Export allows you to digitally export Holter data in a recognized format that can be used by researchers and other investigators. Rx XML Statistics include:

Patient demographics and recording time Scan criteria Summary statistics from the first page of the final report Comment and Narrative summary All information from the second page of the final report (hour-by-hour statistics) List of strips List of all ST episodes List of diary entries Statistics summarized for each period of time between diary entries

Rx XML Export Setup and Data Export 1. If it does not exist, create a file called XML.dir in the H-Scribe Rx C:\Usr folder.

2. Create a destination folder where the exported XML files will be stored. The folder must correspond to the path you enter in the XML.dir file (step #3).

3. Edit the XML.dir file using Notepad, WordPad, or any other text editor. Do not use Microsoft Word. Enter the full path to the XML export folder anywhere on your network (e.g., C:\HolterXML or \\CentralServer\HScribeShare\Protocol2). Save the file and quit the text editor.

If there are multiple H-Scribe Rx workstations, follows steps 1 through 3 for each.

4. Verify that Rx XML Export is sending data to the proper location: 1. Open a patient record 2. Select Patient pull-down menu 3. Select Export XML 4. Select Export Statistics 5. Confirm that Rx XML files were sent to the defined destination

Successful Export!

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Before exporting Rx XML data it is recommended that the patient record be reviewed and edited to ensure its accuracy. Open the Patient drop-down list and click Export XML.

Select the strips to be exported and use the action selections located on the right side of the dialog box to export the data. (See next page.)

NOTE: Sort the list of strip selections in ascending order by clicking the column header matching your criterion. Clicking the same column header a second time will sort in descending order.

NOTE: Only 12-lead, 7.5 second ECG strips will be shown in this dialog window.

After the Rx XML data is exported in this manner, a status flag ‘>’ appears on the Select Patient screen and a text file is automatically saved in the patient directory.

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Select All to highlight all strips.

Include Waveforms includes waveform sample values according to type of recording: high fidelity at 1,000 samples per second or standard at 180 samples per second. NOTE: Waveform files are very large and will take a longer time for export.

When using a high-fidelity CF memory card to acquire patient data, HF Resolution selection will be active and selected waveform samples will export at 1,000 samples per second. If using a standard (24 Hr or 48 Hr) CF memory card, Standard Resolution will be active and selected waveform samples will export at 180 samples per second.

XML Format allows user to choose between: Mortara = Mortara Instrument’s Holter XML format or FDA = HL7 V3 Annotated ECG standard required by FDA

Export Selected Strips exports patient demographic information, strip-time information, and a list of all beats within the strip with information for each beat. (See details on the next page.) To select specific strips in the strip list: Click on the first desired strip Press and hold the Ctrl key Click on all other desired strips

Export Entire Recording exports patient demographic information, time information, and a list of all beats in the entire recording without any strips selected. Export Entire Recording without waveforms exports continuous strip values; Export Entire Recording with waveforms exports continuous strip values plus waveform sample values up to 24 one-hour strips using same file format as for exporting regular strips.

Export Statistics is data from pages 1 and 2 of the final report. Can be used without selecting strips.

Print Selected Strips sends highlighted strips to the default printer.

Done closes window and returns user to patient data display.

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Rx XML Strip Export Export Rx XML dialog starts with the list of strip selections you made as the basis for exporting waveform and beat data. Select any combination of strips and either export or print them using this window. By default the waveform data is not included as it makes the files significantly larger. To include waveforms, select Include Waveforms.

When a strip is exported the Rx XML file includes the patient demographic information as well as information about the time of the strip. Furthermore, the Rx XML file includes a list of all beats within the strip with the following information for each beat: Beat type

o Normal = 0

o SVPB = 1

o VPB = 2

o Paced = 4

o AFib = 6

o R on T = 7

o Artifact = 8

o Unknown = 9

Q onset time in milliseconds

RR duration in milliseconds

Filtered RR in milliseconds

QT interval in milliseconds

NOTE: The 10-second, 12-Lead ECG strips displayed in the Export to E-Scribe window are not included when performing Rx XML Strip Export. Refer to Section 8 for details about this feature.

Rx XML Waveform Export Waveform data included in a strip export is exported in Base64 encoding. If the recording includes high-fidelity data, then by default the waveform data will be exported at 1,000 samples per second. Otherwise the data is exported at 180 samples per second.

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If there is lead fail during any portion of the exported ECG strip (as shown in the example below), the software will ask if you would rather use the 180 samples per second data instead of the high-fidelity ECG. In this condition, 12-lead ECG leads are reconstructed in a safety mode and may be different in amplitude and morphology in the 180 samples per second data as compared to the high-fidelity ECG.

Rx XML File Name and Structure The filename for each Rx XML file is constructed as:

H^<type>^<format>^<duration>_<patientlist>^<slot#>_<id>^<lname>^<fname>^<mname>_<starttime>_<exporttime>.xml

<type> = “STRIP” for strip; “STAT” for statistics <format> = if a strip, “M” for Mortara or “F” for FDA. If not a strip, field and ‘^’ separator are

omitted. <duration> = if a strip, duration is rounded to nearest second. If not a strip, field and ‘^’ separator are

omitted. <patientlist> = patient list name <slot#> = slot number on the patient list <id> = patient’s ID <lname> = patient’s last name <fname> = patient’s first name <mname> = patient’s middle name <starttime> = acquisition time of first sample to nearest second in the format YYYYMMDDHHMMSS <exporttime> = time the strip/statistics/report was exported in the format YYYYMMDDHHMMSS

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Example filename of a 7-second strip in Mortara format from slot 56 on patient list TrialABC: H^STRIP^M^7_TrialABC^56_3243^Smith^John_20031216104632_20040318153145.xml Example filename of a 60-second strip in FDA fomat: H^STRIP^F^60_TrialABC^56_3243^Smith^John_20031216104632_20040318153145.xml Example filename of a statistics XML: H^STAT_TrialABC^56_3243^Smith^John_20031216104632_20040318153145.xml NOTES: The patient list name, ID, first name, and last name will have all illegal characters replaced with a dash

‘-‘. The following characters will be replaced: * ? < > | “ / \ : # _ ^. PDF filename length is limited to 255 characters when PDFLib (in H-Scribe Rx software) is used. PDF filename length is limited to 125 characters when Adobe Acrobat PDF Writer is used. PDF Writer

was included with earlier H-Scribe Rx systems as a component of the web browser option.

Rx XML Exported Status Files Once any portion of the patient record has been exported, a status text file named Exported.txt will be created (or appended to) in the patient directory listing what was exported and when. A line will be added to this file each time data is exported.

Rx XML Export and H-Scribe Rx Custom ID The Rx XML Export feature will export all demographics using the default assumptions for the meaning of each field regardless of any custom ID that might be in use. In support of custom ID, additional demographics will be exported with the labels from the current custom ID. Examples: <DEMOGRAPHIC_FIELD NAME="INDICATIONS" LABEL="Indications" VALUE="Syncope" /> <DEMOGRAPHIC_FIELD NAME="MEDICATIONS" LABEL="Medications" VALUE="PROPAFENONE" /> If it exists, custom ID will appear in the black text after “LABEL=”. The examples above are not customized.

Rx XML Schema Files Each Rx XML export includes XML schema files that can be used by external programs to validate the XML output. The schema files are installed in the C:\Program Files\Mortara Instrument Inc\H-Scribe\XML directory. The files used for validating Mortara XML format files are HolterECG_V5.dtd (for strips) and HolterStatisticsRx_V5.dtd (for statistics). The files for validating FDA XML format files are stored in the dt, meta, rim, schema, and voc subdirectories. These files are automatically exported to the destination folder together with the Rx XML exported files.

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Introduction Rx Export to E-Scribe allows you to digitally export high-fidelity (1,000 Hz) 12-lead ECG Holter data in a format that can be imported at the E-Scribe Rx.

Requirements A successful export requires the following:

High-fidelity Holter data acquired at H-Scribe Rx 12x1 is selected for 12-Lead Display Mode in User Profiles 10 Sec Landscape is selected for 12x1 Strips in User Profiles Import path and site number are defined in Edit Patient List Location E-Scribe Rx has been setup to import Holter ECG, or a network directory has been defined

NOTE: Standard (180 Hz) Holter data can be upsampled to 1,000 Hz when high-fidelity data is not available. The user will be prompted with a choice when required.

Rx Export to E-Scribe Setup and Data Export 1. Select User Profiles from the Edit pull-down menu to define 12-lead display mode and 12x1 strips. Refer to

Section 11 for more detail.

12-Lead Display Mode must be set at 12x1 and 12x1 Strips must be set at 10 Sec Landscape in order to view ECG strips in the Export to E-Scribe dialog window. The 10-second 12-lead ECG strips will print in the H-Scribe Rx final report as 10-second strips in 3x4+ 1 ECG format.

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2. 12-lead ECGs will export according to the path defined in the Edit Patient List Location on a per patient list basis. Browse to or enter full path to the E-Scribe Rx import folder anywhere on your network (e.g., N:\import or \\computer\sharename\import). Select Add/Update to save changes.

3. Ensure that E-Scribe Rx has been setup for import of H-Scribe Rx ECG files. Alternatively, a directory can be setup to receive exported ECGs in UNIPRO format for exporting the files to the E-Scribe Rx location at a later time. For assistance with E-Scribe Rx setup, contact Mortara Instrument Technical Support Group. Contact information is located in the user manual cover section.

4. Verify that Rx Export to E-Scribe is sending data to the proper location:

1. Open a high-fidelity patient record 2. Select a 10-second, 12-lead strip in ECG display view 3. Select Patient pull-down menu 4. Select Export to E-Scribe 5. Select 12-lead strips from displayed strip list 6. Select Export Selected Strips 7. Select Done when finished 8. Confirm that 12-lead ECG files were sent to the E-Scribe Rx import folder at the E-Scribe Rx

NOTE: If E-Scribe Rx is already configured for import, the files will be moved within 60 seconds.

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Before exporting high-fidelity data it is recommended that the patient record be reviewed and edited to ensure its accuracy. Open Patient drop-down list and click Export to E-Scribe.

Select strips to be exported and use the action selections located on the right side of the dialog box to export the data. (See next page.)

NOTE: Sort the list of strip selections in ascending order by clicking the column header matching your criterion. Clicking the same column header a second time will sort in descending order.

NOTE: Only 12-lead, 10-second ECG strips will be shown in this dialog window. If a 12-lead ECG is a multiple of 10 seconds, a 12-lead strip will be exported for each 10-second increment.

After the high-fidelity data is exported in this manner, a text file named UniproExported.txt is automatically saved in and appended to the patient directory.

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Select All highlights all strips.

Export Selected Strips exports 12-lead strips with demographic information. To select specific strips in the strip list: Click on the first desired strip Press and hold the Ctrl key Click on all other desired strips

Use AC Filter to choose between 50 Hz and 60 Hz AC filtering when processing H12+ data. Selections are based on country’s AC power frequency where recording was performed and defaults to the last selection used. You can “Disable” the AC Filter in this window when desired. NOTE: AC Filter selections are disabled when data originates from the Surveyor

Telemetry Central System because filtering has already been performed.

Done closes window and returns user to patient data display.

E-Scribe Site Number: is for user notification purposes only and cannot be changed in this window. Value can be edited in the H-Scribe Rx Edit Patient List Location dialog window.

NOTE: The Export to E-Scribe list will display only 10-second ECG strips not 7.5 second ECG strips.

NOTE: 10-second 12-Lead ECG strips displayed in the Export to E-Scribe window are not included when performing Rx XML Strip Export. Refer to Section 7 for details about the Rx XML Export feature.

NOTE: All 10-second 12-Lead ECGs within the same patient list will be exported to the same E-Scribe Rx workstation unless the E-Scribe Site Number is changed.

NOTE: Once the 12-Lead ECG is exported, the record cannot be moved to a different E-Scribe Site. Ensure that this value is properly defined in the H-Scribe Rx Edit Patient List Location window.

NOTE: If a duplicate 12-Lead ECG strip (same patient demographics, time, and date) is selected for export, you will be prompted with a message and the strip will be rejected. A dialog, will warn the user.

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UNIPRO ECG Exported Status Files Once a patient record has been exported, a status text file named UniproExported.txt will be appended to the patient directory listing what was exported and when. A line will be added to this file each time data is exported. Rx Export to E-Scribe and E-Scribe Custom ID The Export to E-Scribe feature exports demographics using the custom ID created at the E-Scribe Rx server if the E-Scribe configuration file is shared and the Network Path Of E-Scribe Custom ID Configuration Files has been defined in the Edit Patient List Location dialog window.

NOTE: E-Scribe configuration files can be copied and pasted into the H-Scribe Rx Patient List directory when the E-Scribe is not networked.

When the “Comment” field is added to the E-Scribe custom ID, exported ECG strip annotations will be included in the ECG demographic data in the E-Scribe Rx Holter ECG. Holter ECGs exported to E-Scribe Rx will include the statement “Note: Limb leads might have been placed on torso” due to the Mason-Likar lead placement typically used for ambulatory patient monitoring. An example of a portion of an E-Scribe Rx Holter exported ECG configured with an E-Scribe Rx custom ID is shown below.

Refer to Section 11 for detailed instructions. When this configuration setup is not performed with E-Scribe Rx, default assumptions for the meaning of each field, regardless of any E-Scribe custom ID that might be in use, will be shown. Patient demographics will be imported into E-Scribe Rx using the electrocardiograph Short Format that consists of name, ID#, date of birth, and gender. Example: DEMOGRAPHIC FIELD NAME="LAST NAME" CUSTOM ID LABEL="Initials" VALUE="SRB"

In the example, “SRB” will appear as last name in the 12-lead ECG at the E-Scribe Rx.

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ARCHIVE SECTION 9

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Introduction The H-Scribe Rx allows for multiple patient archive storage to a DVD+/-RW disc, CD-RW disc, or any arbitrary drive such as the local hard drive, a removable drive, or a network location. Entire 24- or 48-hour recordings are saved enabling you to restore full-disclosure recordings back onto the H-Scribe Rx for further review, editing, printing, and/or final report generation. Scan Criteria used to analyze the recording is saved with the data allowing you to review and print with the same criteria originally used. The Narrative summary, if enabled, is also saved with the original data. The H-Scribe Rx includes a rewritable DVD+/-RW disc drive which allows you to write multiple sessions to, and read from DVD+/-RW, DVD+/-R, and CD-RW discs. Discs must be formatted before use. The first time disc is used, the H-Scribe Rx automatically writes a new volume label onto the disc. When full, the system will prompt you to insert a new formatted disc. The number of recordings that can be stored depends on the size of the data files: 1. High-fidelity recording are approximately 500 MB. 2. Standard 24-hour recordings are approximately 40 MB. 3. Standard 48-hour recordings are approximately 80 MB. 4. H3+ 24-hour recordings are approximately 200 MB. 5. CD-RW discs have approximately 650 MB of space. 6. DVD+/-RW discs have approximately 4.7 GB of space. Discs record on the side opposite the label. To protect the recording side from scratches, fingerprints, dust particles and/or smears, never touch the recording side or place it face down on a hard surface. The following pages provide step-by-step information on how to format new CD-RW or DVD+/-RW discs before use.

NOTE: The H-Scribe Rx is delivered with the DVD+/-RW disc drive setup for archiving all data. If you wish to change this setting to an arbitrary drive, please refer to Section 11 for details.

NOTE: It is recommended you format all discs at one time and place them in a location near the H-Scribe Rx, for when patient data archiving is desired. The format utility prompts you to enter a label. Leave the label blank to allow the H-Scribe Rx to automatically generate a new volume label for the disc (e.g., Archive Data 1, Archive Data 2, etc.).

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Formatting New CD-RW or DVD+/-RW Discs The following applies to using the DVD+/-RW drive with Roxio Easy Media Creator version 9 software. To write data to your DVD (recorder) drive, you must first format the disc(s) you wish to use.

1. Insert new CD or DVD into the DVD drive.

2. In Windows Explorer, right click your DVD drive.

3. Select Format.

4. A Format Options window prompts you to label the disc. Delete name, leaving the field blank. Select OK to begin a quick format.

5. A Disc Preparation window prompts you to wait while the disc is being prepared. After it closes the disc

is ready to use.

Using Formatted Discs Upon first archive to a formatted disc, a message informs you of the volume number automatically assigned by the H-Scribe Rx.

NOTE: Immediately after the system creates the new label, mark the disc with the volume label for future location of patient data.

Upon ejecting the formatted disc, a prompt will ask you to either leave the disc open or to close it. Leave the disc open to write to it again. Selecting Eject will prompt you to wait while the system prepares the disc. Alternatively, open the Drag-to-Disc program using the Windows Start menu. Open the Drag-to-Disc menu and save to the H-Scribe Rx desk top. Menus and help are then available through the icon.

NOTE: It is recommended you use DVD+/-R discs as protection against data loss. Once the disc is full, “Close the disc” when prompted upon ejection to prevent anyone from deleting the archived data. Archived data on DVD+/- RW discs cannot be protected and can be erased.

NOTE: Media discs formatted by or used to archive with H-Scribe Rx Sonic DLA are not compatible with the newer DVD+/-RW drives using Roxio Easy Media Creator version 9 software.

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Archiving a Single Patient

After editing, printing, or exporting the final report, return to the Select Patient screen by clicking on the Open Patient icon or by selecting Open Patient in the Patient pull-down menu. To archive a single patient recording:

1. Click on the desired patient record to select for archive.

2. Click Archive and then a prompt is displayed.

3. YES will delete the patient record from the hard drive after archiving.

4. NO will keep a copy of the patient record on the hard drive after archiving. If a hard drive copy is kept, B

(backup status flag) is added in the Status column.

After selecting Yes or No, a progress indicator is displayed on the screen. After archiving, the system returns to the Select Patient screen. NOTE: To cancel an archive in progress, click Cancel or press the ESC key.

Batch Archiving For more efficient archiving, you can perform a batch archive. Batch archiving allows you to save more than one patient record simultaneously. To begin a batch archive:

1. Click on the first patient record to select for archive. 2. To select additional patient records that are not in consecutive order, hold down the Ctrl key and click on

each record individually.

3. Alternatively, hold down the SHIFT key and click on the last patient to archive. All patients from the first selected patient to the last selected patient will be archived.

4. Click Archive. Follow steps as explained for archiving a single patient record.

5. After clicking on Archive, you will be prompted to remove data after archiving. YES will delete all

selected data after archiving; NO will retain all data on the hard drive after archiving.

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Restoring Patient Recordings from Archive H-Scribe Rx maintains an index of all archived patient records on the system’s hard drive. This provides information about the specific archive disc on which a patient record has been saved. The system also provides an index of the disc you are currently using in the event you want to read a disc used by another H-Scribe. You can save more recordings from the same patient based on recording date and time.

NOTE: You cannot archive patients on media that has been used on another H-Scribe; however, you can retrieve patient records that have been stored on media from other systems.

To restore a recording from a disc:

1. Select the empty slot in the Select Patient dialog where you want to place the restored patient record. Click Restore and the Select Patient From Archive screen is displayed.

NOTE: The slot must be empty for Restore to be active.

2. The system displays the name, ID, date and time of recording, and the Volume name if the data was archived to a CD or DVD for all archived patient records. Use the Volume name to track which disc contains the patient record(s) you want to restore.

NOTE: The Volume label will be blank when the data is not archived to CD or DVD media.

NOTE: The archive list is automatically sorted by patient name. Click on any column header to sort the list in ascending order by the selected criterion. A second click on the same column header will sort the list in descending order.

3. To read a disc not originally used on your system, select Show Archived Patients on Current Media to

access the disc’s index. 4. Select the recording you want to retrieve and click Restore. The entire patient recording is placed in the

selected slot. 5. To review the patient recording, click Review and proceed as usual.

NOTE: Scan Criteria used to analyze the recording is saved with the file. When restored, patient records can be reviewed with the exact scan criteria used before archiving.

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Support for Auditing Changes to the Patient Record Each time a patient recording is closed, a read-only text file and a PDF of the statistics (first two pages of the final report) is generated and saved in the patient directory. This allows the ability to audit the changes made from one editing session to the next. The H-Scribe Rx classifies beats based on Mortara Instrument’s VERITAS ECG algorithms. Each beat label will be shown in the text file. Changes to the record between sessions can be determined by comparing these automatically generated files. The patient recording access PDF and text files are located in the patient directory. Files with a “txt” extension will show the Windows user name, patient demographics, scan criteria, strip

list, diary list and all beats including their beat numbers, sample numbers, and beat labels when opened.

Files with a “pdf” extension contain information identical to the first two pages of the H-Scribe Rx final report. Audit trails for exported files listing the time, date and other information about the files that were exported are also shown in the patient directory. They are:

Exported.txt = Mortara XML strips, FDA XML strips, and Rx XML statistics UniproExported.txt = Unipro 12-lead ECG exports ReportExported.txt = Interface export XML text and PDF final report exports

Audit trail file name formats are:

H^<type>_<patientlist>^<slot#>_<id>^<lname>^<fname>^<mname>_<startime>_<exporttime>.pdf

H^<type>_<patientlist>^<slot#>_<id>^<lname>^<fname>^<mname>_<starttime>_<exporttime>.txt

Audit trail file name definitions are shown below:

H = Holter data <type> = “PAT-STAT” for statistics <patientlist> = patient list name <slot#> = slot number on the patient list <id> = patient identification number <lname> = patient’s last name <fname> = patient’s first name <mname> = patient’s middle name <starttime> = acquisition time of the first sample to the nearest second (YYYYMMDDHHMMSS) <exporttime> = time the statistics/report was saved (YYYYMMDDHHMMSS)

Text files can be visually compared for audit by viewing the files side-by-side. Various text comparison tools, such as Microsoft WinDiff.exe utility that graphically compares ASCII files, can also be used. PDF files can be visually compared for any changes to the scan criteria, summary statistics, and rhythm profile. Various text comparison tools can also be used.

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Audit Trail File Location All read-only audit trail files (both PDF and TXT) will be automatically placed within each individual patient directory (e.g., C:\Usr\Patxx). A configuration file can be used to direct these audit trail files to a user-created directory. Refer to Section 11 for details.

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H-Scribe Rx Assembly Unpack and inspect cartons carefully for evidence of damage due to shipping. If any damage is noted, immediately notify the Technical Support Group at Mortara Instrument, Inc. (1.888.MORTARA) for assistance. Attach the appropriate equipment cables to the keyboard, mouse, laser printer, and monitor. Connect opposite end of cables to the CPU tower’s color-coded connections. Ensure all connections are secure before connecting any power cables. Please note the computer hardware is subject to change. Connection locations may vary.

H-Scribe Rx Interconnections CPU and Parallel Port/Dongle/USB Connections

USB Port Dongle connects to any USB

port Network Connection

USB Ports (6) Video Connection Parallel Port for Serial Dongle and Printer Keyboard & Mouse Ports NOTE: either a parallel port dongle or a USB dongle is used to activate the system features.

H3+ recorder with interface cable connects to any USB port

Compact flash card reader with interface cable connects to any USB port

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Interacting with Windows Environment H-Scribe Rx is based on a Windows operating system and runs on an industry-standard platform. Conforming to Windows’ intuitive “graphical user interface,” the H-Scribe Rx uses the mouse to point, click, and drag what is displayed on the monitor. Keyboard entries, called shortcut keys, can also be used in conjunction with the mouse.

H-Scribe Rx Operation A dongle is required to operate full H-Scribe Rx software functions such as acquisition, network access, storage, archiving, and export. Without the dongle the system will function in a limited “demo” mode where patient data acquisition and network access are disabled. DEMO MODE will display in the H-Scribe List of Enabled Features and the Select Patient screen will limit display to the first five slots of the patient list. The software required to perform Holter scanning functions is pre-installed. For system customization, the following edit and display options can be modified:

User Profiles. Refer to Section 11. Scan Criteria. Refer to Section 2. Report Header. Refer to Section 4.

System Security and Privacy Setup The H-Scribe Rx offers network capabilities. More than one system can be installed on the same network to exchange patient data and final reports. Remote sites share drives and there is no login or password required to run the H-Scribe software. A higher level of security, however, can be achieved through an existing local network with a security policy already in place. It is the responsibility of the local network administrator to connect the H-Scribe Rx system to a network and to assign users’ login names and passwords. The H-Scribe Rx houses sensitive patient information. Take steps to secure individual files and folders as well as the physical computer itself. Set a password-protected screen saver for periods of user absence or non-activity (user specified length of time). Press Ctrl+Alt+Delete and click Lock Computer to prevent unauthorized users from gaining access. Press Ctrl+Alt+Delete, type the password, then OK to unlock. Screen Saver and Password Selection 1. Open Display in Control Panel. 2. Select a screen saver from the tab under Screen saver. 3. Select On resume, password protect. H-Scribe Rx security includes use of passwords for network logon and Administrator access. For a password to be strong, it should:

Be at least seven characters long. Contain a combination of letters, numbers, and symbols. Be significantly different from prior passwords. Not contain your name or user name. Not be a common word or name.

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Changing a Password 1. Open User Accounts in Control Panel. 2. Under or pick an account to change, click your account. 3. Click Change my password. 4. Type current password in Type your current password. 5. Type new password in Type a new password and Type the new password again to confirm. 6. Type a word or phrase to use as a memory aid for the new password in Type a word or phrase to use as a

password hint. 7. Click Change Password.

Network Connection Security and Privacy Setup Shared Files and Folders Security Using Window’s standard security settings, you can choose which user(s) and/or networked workstation(s) can access H-Scribe Rx files and folders stored on a shared network. This is called setting permissions. To set, view, change, or remove file and folder permissions open Windows Explorer: 1. Click Start, point to Programs, point to Accessories, then click Windows Explorer. 2. Locate the file or folder for which you want to set permissions. 3. Right click the file or folder, click Properties, then click Security tab. 4. Do one of the following:

o To set permissions for a group or user not in the Group or user names box, click Add. Type the group or user name then click OK.

o To change or remove permissions from an existing group or user, click the name of the group or user. 5. Do one of the following:

o To allow or deny permission, select Allow or Deny in the Permissions for User or Group box. o Click Remove to remove the group or user from the Group or user names box.

User Profiles Setup To setup a user profile, select User Profiles from the Edit pull-down menu. User Profile is a group of configurable settings for display formats, Prospective scanning mode preferences, and optional network configurations. At setup or during operation, users select from a list of options for each setting to configure a profile that reflects their preferences. Defined settings are automatically incorporated when the user logs into the system. User Profiles can be customized for each user. A Default User Profile containing default settings for typical scanning applications exists. Each new profile is initially copied from the Default User Profile. As such, the Default User Profile can be modified to reflect general preferences.

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Customize User Profiles through the User Profile dialog. Changes are incorporated immediately and remain in effect until the profile is modified again. A user can modify another name in the User Profile Name list box; however, Add, Delete and Rename functions require an administrative password to proceed. To add a User Profile, click on Add and enter administrative password. Type new NameX (NameX = user

name) in the User Profile Name list box. The new User Profile is copied from the previously selected profile. To verify and implement the new User Profile, log off the system and log on with the new user name. The system automatically implements the new User Profile.

NOTE: If another profile is selected before clicking on Add, the new NameX profile will be a copy of that same User Profile.

To delete or rename a User Profile, enter administrative password and select desired profile. Click on Delete or

Rename. The User Profile screen is divided into six sections: 1. User Profile management functions

Includes adding, deleting, or renaming the User Profile displayed in the User Profile Name list box. The name displayed indicates the User Profile currently used by the system. By virtue of login, the system selects the preferences as configured for that User Profile.

2. Select Patient screen preferences The Default Patient List is the Patient List data that will display on the Select Patient screen upon log in. Specify the column or category to use for sorting from Default sorting criteria then choose either Ascending or Descending order.

3. General display and editing preferences

Available choices for the Graphical User Interface (GUI) language are listed in the Default GUI language list. Select new language then exit and restart the application. Select one of twelve leads to display in Context view from Default lead in Context View. 12x1 Display Mode presents 20 seconds of ECG in a single column; 6+6 Display Mode presents 4 seconds of data in two columns of six leads. The same 4-second time period is mirrored in each column. 12x1 Strips offers two final report layouts for the 12x1 ECG display: Selecting 7.5 Sec Portrait will print the 12x1 ECG on one page with 7.5 seconds of waveform for each

ECG lead. This selection is required when choosing 12-lead ECG strips for Rx XML export. Selecting 10 Sec Landscape will print the 12x1 ECG on one page with 10 seconds of waveform in 3x4

with one rhythm strip channel labeled as Lead II. This selection is required when choosing 12-lead ECG strips for export to E-Scribe.

4. Archiving preferences

Control the storage size of files used for reassigning channels for H3+ recordings. Selecting All Files will save the large raw data files; selecting Analysis Only will save the files used for analysis. Recordings archived with Analysis Only can be rescanned, but cannot use different analysis leads.

5. Prospective scanning preferences

User preferences for Prospective Scanning are divided into general scanning functions and active Scanning and Paused display modes. User can also change display settings using the toolbar and menus when the system stops at an event; however, each time the scan continues and each time the scan pauses, the User Profile settings are reapplied.

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6. Interface Export preferences Two automatic functions are activated by selecting Interface Export. Include when Exporting Report

Selection of this checkbox will result in automatic Interface XML Export and a final report in PDF format when Export Report is selected in the Report Preview print display. Selection will also export a PDF of the final report for use with the Athena option at the same time.

Automatic when marked as Reviewed Selection of this checkbox will result in automatic Interface XML Export and a final report in PDF format when the Holter recording is marked as Reviewed after scan completion.

Archive Setup H-Scribe Rx allows you to archive recordings to and restore recordings from arbitrary network locations in addition to CD-RW, DVD+/-RW, or other removable media (see Section 9). Archive/Restore can also be defined per-Patient List as explained in Configuration File Setup located in this section. Archive/Restore supports an arbitrary path to any valid directory on the local hard drive, a removable drive, or a network path (either mapped network drives or a UNC path such as \\ServerName\ShareName\Directory). Specify the arbitrary path (the E: drive is set by the factory) on line one in the C:\Usr\ArchiveConfig.txt file. Specify the volume name to assign to removable media (e.g., DVD-RW, CD-RW, etc.) on line two. Volume

names will not display in the “Restore” dialog when you archive to a computer directory. Specify the volume number you wish to begin with on line three (if you have previous archived media volumes

and don’t want duplication of volume numbers).

Audit Trail Files Setup Use a configuration file C:\usr\AuditTrailPath.txt to direct all audit trail files to a user created directory (see Section 10). When this configuration file is not present in the C:\Usr directory, audit trail files will be located within each individual patient directory (e.g., C:\Usr\Patxx). When this file is present and contains a valid path to a directory you have created, all patient and Patient List audit trail files (both PDF and TXT) are automatically placed in this one directory.

Patient List Locations Setup The H-Scribe Rx automatically creates a directory called Usr on the C drive of the local computer. The Usr directory contains folders where acquired patient recording files are stored. To separate groups of patient recordings, create additional Usr directories on the local computer or on a networked server. Access Usr directories by using the Patient List drop down from the Select Patient screen displayed when acquiring and/or reviewing Holter recordings. This list is also used to access other networked H-Scribe Rx workstations. To add a remote H-Scribe Rx workstation, a local computer Patient List, or a networked server Patient List location to your H-Scribe Rx network, check first that the remote workstation or server is turned on and accessible via the network. Enter a new name in the Patient List Name box from the Edit Patient List Location dialog. As this name is used only in the Patient List box in the Select Patient screen, you can enter any descriptive name.

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In Network Path Of Parameter Directory of Patient List, enter the remote workstation or networked location path for where the configuration and parameter files are kept as \\ComputerName\ShareName\Usr where ComputerName is the network name of the remote workstation or networked server, and ShareName is the network share name of the drive for the remote workstation or networked server. Both names are typically assigned by either IT personnel or the office administrator. Usr is the directory on the computer hard drive where the parameter files are stored. After entering the new name and path, click on Add to add this Patient List. When all desired Patient Lists have been added, click OK to save.

NOTE: If the Patient List cannot be accessed or the correct parameter files cannot be found at the specified network address, an error message is displayed.

Add adds a reference to an existing Patient List or creates a new Patient List directory.

Update revises an existing patient list.

Delete deletes a reference to a Patient List; the directory will not be deleted.

Define an unlimited number of Patient List slots using the numeric field under Patient Directories. Decreasing this number when there is existing data will result in only empty slots being removed.

OK saves revisions after any changes. The Network Path of E-Scribe Server Import Directory defines the directory location where Holter ECGs in Unipro format will be exported. The E-Scribe Site Number defines the site where H-Scribe Rx exported 12-lead ECGs will reside in the E-Scribe Rx database.

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High-Fidelity 12-Lead ECG Export and E-Scribe Custom ID Setup

Holter 12-lead ECGs exported to an E-Scribe Rx system will use the custom ID created at the E-Scribe Rx server when the Network Path Of E-Scribe Custom ID Files is shared with read permissions, and the Edit Patient List Location dialog window points to the shared E-Scribe Rx configuration files. When the E-Scribe Rx server is not available for H-Scribe Rx network access, the E-Scribe Rx configuration files can be copied onto a networked location.

Additionally, when the “comment” field is added to the E-Scribe custom ID, the H-Scribe Rx Holter ECG strip annotation will be included in that E-Scribe Rx ECG demographic data.

The table below represents H-Scribe Rx field mapping to corresponding E-Scribe Rx custom ID fields when they exist.

H-Scribe Rx Field Name

E-Scribe Rx Max Characters in Custom ID

E-Scribe Rx Field Name E-Scribe Rx Displays these

Values if Field is Blank Patient Last Name 20 Patient Last Name Blank Patient ID Number 23 Patient ID Number Blank Patient Age 3 Patient Age 0 Patient Gender 7 Patient Gender Blank *Not Provided 17 Patient Race Blank Medications 20 Medication 1 and 2 Blank Patient First Name 20 Patient First Name Blank *Not Provided 23 Lcd Request Blank *Not Provided 3 Patient Height 0 *Not Provided 3 Patient Weight 0 *Not Provided 9 – 11 Soc Sec Number Blank Second ID 23 Second ID Blank Patient Middle Name 7 Patient Middle Name Blank *Not Provided 5 Patient Location Blank *Not Provided 5 Patient Room Blank Patient Birth Date 10 Patient Birth Date Blank Strip Annotation 20 Comment Blank *Not Provided 4 Reason Code 0 Referring Physician 23 Referring Physician Blank *Not Provided 23 Attending Physician Blank Reviewing Physician 23 Overreading Physician Blank Analyst 7 Technician Blank Indications 23 Diagnosis Blank *Not Provided 23 Note 1 Blank *Not Provided 23 Note 2 Blank *Not Provided 3 Systolic Blood Pressure 0 *Not Provided 3 Diastolic Blood Pressure 0 Hookup Tech NA Not mapped NA Scan Number (numerical, 0 to 65535)

5 Sequence Number 0

Recorder Number (numerical, 0 to 65535)

5 Cart Number 0

*These fields not provided by H-Scribe Rx and are set to blank or 0 (zero) at E-Scribe Rx.

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Configuration Files Setup Configuration files can be provided locally, centrally, or on a per-patient-list basis when a specific central configuration file is present. This feature allows you to use different configurations for recordings that are grouped according to variable originating locations. 1. Locally (in C:\Usr on computer hard drive) and applied to all Patient Lists edited from that computer.

Example: you wish to have different Quick Lists on each computer. This is the H-Scribe Rx default. No changes are required to enable this configuration.

2. Centrally (in any network-accessible directory) and applied to all Patient Lists edited from all computers. Example: you wish to have all computers on your network use the same configuration for all Quick Lists.

3. Per-patient-list basis so that any workstation editing a patient recording in that Patient List will use the same configuration files. Example: A central scanning lab collects recordings from various clients with different definitions and desires to have each Patient List (or Usr directory) use different Quick Lists.

Configuration files whose location is configurable includes:

Filename Usage

ACFilterMode.txt Most recently used Unipro AC filter mode

Acronyms.txt Acronym Quick List

Analyst.lst Analyst Quick List

ArchiveConfig.txt Configuration for Archive/Restore feature

ArchiveHistory.txt List of patients archived

Arrhy.dat Master scan criteria

AuditTrailPath.txt Path for audit trail files

Browse.dir Athena export path

CentralUploadPath.txt Surveyor Telemetry data path

DiaryAnnotations.txt Diary annotations Quick List

EScribeExportPath.txt E-Scribe export path for Unipro files

EScribeSiteNumber.txt E-Scribe site number for Unipro files

ExportFilenameFormats.txt Export Output file name format (PDF & XML)

Hookup.lst Hookup technician Quick List

HScribe.Nam Report headers

Indicat.lst Indications Quick List

Interface.dir Interface export path

Medicat.lst Medications Quick List

NarrativeXXX.txt Narrative summary templates, all languages

Nterpmd.lst Reviewing MD Quick List

PatientDemographicLabelsV2.txt Custom ID

Refermd.lst Referring MD Quick List

ReportOptions.xml Final Report default options

Rhycomm.lst Strip annotation Quick List

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Filename Usage

Scan.num Auto-incremented number of scans

StopCriteria.txt Stop criteria

WebUploadPath.txt Web server upload path

XML.dir XML export path

Specify the path to use when accessing files in the table in an optional local configuration file located in C:\Usr directory: C:\Usr\ConfigurationFileLocations.txt. If C:\Usr\ConfigurationFileLocations.txt is not present, the system will search for files by assuming all files are to be located in the C:\Usr directory except for the following files that are per patient list:

o EScribeExportPath.txt o EScribeSiteNumber.txt o Interface.dir o PatientDemographicLabelsV2.txt o XML.dir

For each configuration file listed in the table, C:\Usr\ConfigurationFileLocations.txt can optionally specify where to obtain the configuration file. Any configuration file from the table that is not listed in C:\Usr\ConfigurationFileLocations.txt will use the default location for that file. For each non-comment line of C:\Usr\ConfigurationFileLocations.txt, the name of the configuration file must be at the beginning of the line, followed by a space. The remainder of the line must be the path to the file’s location. The path can be any valid local or network directory. Network paths can be used to centralize configuration files (e.g., Quick Lists) for several workstations in a single network directory.

If the path is PER PATIENT LIST (with one space between the words) then the file will be accessed from the parameter directory of each Patient List. This allows you to have a different custom ID for each Patient List.

Each time one of the configuration files is accessed in read mode, H-Scribe Rx will check to see if it is a local file. If the file is not specified as local (C:\Usr):

The file will be copied to the specified location from C:\Usr. (Only if a copy does not already exist in the specified location.) Two exceptions are: If the file is from a location other than C:\Usr, its contents should reflect what had been archived or

acquired from that location (either globally if a central network location, or patient list specific) rather than copy the current list or number from the local computer.

Master files for ArchiveHistory.txt and Scan.num will not be copied. The master copy of all files in C:\Usr will be preserved to allow software versions prior to H-Scribe Rx

v4.20 to still operate correctly using local copies. In a networked environment with multiple H-Scribe Rx systems, the first H-Scribe Rx to access each

configuration file after installation or upgrade will be the one to copy its configuration file(s) to the network as the master copies of those files, unless files are manually copied ahead of time.

When writing files in locations other than C:\Usr, files will be written without copying the master file. Configuration File setup requires the following:

1. Exit H-Scribe Rx application. 2. Open Windows Explorer and navigate to H-Scribe Rx C:/Usr directory. 3. Create ConfigurationFileLocations.txt file and save to C:/Usr directory. 4. Open text file and follow instructions above to implement desired changes. Save and close file.

Contact Mortara Technical Support personnel for assistance with this feature.

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Interface Export Setup

Interface Export allows for digital export of Holter patient demographics and statistical results in XML format with the entire final report in PDF format. This feature enables connectivity to other devices and allows the development of an interface for the devices to accept information from H-Scribe Rx.

Interface Export is controlled by two checkboxes in the User Profiles dialog.

1. Include when Exporting Report

2. Automatic when marked as Reviewed

The path for all exported XML and PDF files is controlled by the file Interface.dir located in the root patient directory of the Patient List whose data you are reviewing. The root patient directory is the network path that is defined in the Edit Patient List Location dialog. Refer to User Profiles Setup in this section for additional detail.

1. Create a file called Interface.dir in C:\Usr folder.

2. Create a destination folder for storing the exported files. Folder must correspond to path name entered in the Interface.dir file. For multiple Patient Lists, create an Interface.dir file in each Usr folder. Be sure to create the destination folders referenced in the Interface.dir files.

3. Edit the Interface.dir file using Notepad, WordPad, or any other text editor. Do not use Microsoft Word. Enter the full path to the Interface Export folder anywhere on your network (e.g., C:\HolterInterface or \\CentralServer\HScribeShare\Protocol2). Save file and quit text editor.

Refer to Section 6, Interface Export, for detailed instructions on using Interface Export selections.

PDF Only Export Setup

PDF Only Export allows for digital export of the entire final report in PDF format. This feature enables connectivity to Athena and other devices that can accept the final report in PDF format.

When the Interface Export feature is enabled on your system and you only want to export the Final Report in PDF format to the Browse.dir file destination, disable the two Interface Export checkboxes in the User Profiles dialog as shown below.

Refer to User Profiles Setup in this section for additional detail.

The path for all PDF Only exported files is controlled by the file Browse.dir located in the root patient directory of the Patient List whose data you are reviewing. The root patient directory is the network path that is defined in the Edit Patient List Location dialog. Refer to User Profiles Setup in this section for additional detail.

1. Create a file called Browse.dir in C:\Usr folder.

2. Create a destination folder for storing the PDF files. Folder must correspond to path name entered in the Browse.dir file. For multiple Patient Lists, create a Browse.dir file in each Usr folder. Be sure to create the destination folders referenced in the Browse.dir files.

3. Edit the Browse.dir file using Notepad, WordPad, or any other text editor. Do not use Microsoft Word. Enter the full path to the PDF folder anywhere on your network (e.g., C:\HolterInterface or \\CentralServer\HScribeShare\Protocol2). Save file and quit text editor.

NOTE: This feature together with Interface Export allows export of the same final report PDF to be sent to two separate destinations.

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Rx XML Export Setup Rx XML Export allows for digital export of Holter ECG waveform and statistics in a recognized format (XML) that can be used by researchers and other investigators. Rx XML Export is executed by selection of Export XML… from the Patient drop-down menu.

Rx XML Export setup requires the following: 1. Create an XML.dir file in C:\Usr folder. 2. Create a destination folder for storing the XML files. Folder must correspond to path name entered in the

XML.dir file. For multiple H-Scribe Rx workstations, create an XML.dir file in each workstation’s Usr folder. Be sure to create the destination folders referenced in the XML.dir files.

3. Edit the XML.dir file using Notepad, WordPad, or any other text editor. Do not use Microsoft Word. Enter the

full path to the XML export folder anywhere on your network (e.g., C:\HolterXML or \\CentralServer\HScribeShare\Protocol2). Save file and quit text editor.

Refer to Section 7, Rx XML Export, for detailed instructions on using Rx XML Export selections.

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Custom ID Setup Use custom ID to change or hide demographic field labels for the Patient Information window, Select Patient window, and in the final report. This feature also allows users to disable automatic age calculation from DOB field in the Patient Information window, and to re-align demographic labels. Examples showing the results of some custom ID changes are shown at the end of this section. Label Customization 1. Exit H-Scribe Rx application.

2. Open Windows Explorer.

3. Navigate to C:\Usr directory.

4. Open text configuration file PatientDemographicLabelsV2.txt.

a. A text file containing default label text and locations for each of the following languages is available: o ENU is English o ITA is Italian o DEU is German o NLD is Dutch o CHS is Chinese simplified o FRA is French o ESN is Spanish o PLK is Polish o HUN is Hungarian

b. When selected, text document will open in Notepad. 5. Customize desired text labels for demographic fields.

6. Save edited text file as PatientDemographicLabelsV2.txt in appropriate Usr directory.

As a default, customization will affect only this Usr directory (Patient List). Customized files can be setup locally or per patient list. See Configuration Files Setup in this section.

NOTE: XML Export and Interface Export will export all demographics using the default meanings for each demographic field (e.g., Name, ID#, Age, Sex, Scan Number, Referring Physician, etc.). Demographics will export together with the labels from the current customized labels. Date and Time fields are always treated as date(s) and time.

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Text shown will be displayed in Notepad. Lines preceded by “#” provide instructions on how to change labels, align labels, show or hide fields, and disable automatic age calculation. # PatientDemographicLabels.txt # # Version 2 (DO NOT DELETE THIS VERSION NUMBER!!) # # a.k.a. 'Custom ID' configuration file # # This file allows you to customize the text labels for # demographic fields in the final report and the Patient Information dialog, # and customize the location of the demographic items in the final report. # # Each line consists of: # DisplayOrder, LabelX, LabelY, LabelAlignment, DataX, DataY, DataAlignment, ShowField, TextLabel # where # DisplayOrder is the 0-based order in which the fields will be parsed when printing the # final report (0 is parsed first). This can make a difference when you use an odd # Alignment value to cause one item to follow another on the same line - if you # want Age to follow Sex, then Age must have a HIGHER DisplayOrder. These # indexes MUST be unique and monotonically increasing. This is ignored for the # SECTION_HEADER, AGE_AUTOCALC, COMMENT and REVIEWING_PHYSICIAN fields. # Note that a value of -1 is used to indicate those 4 items (e.g., SECTION_HEADER) # whose display order is not configurable. DO NOT change these -1 values!! # (New in version 2 of this file) # X and Y are the coordinates of the item and (0,0) is the upper left corner # of the Patient Information section of the first page of the final report. # Alignment is the left/right/center alignment of the item # 0 = Left # 2 = Right # 6 = Center # Add 1 to this value if you want the item to immediately follow # the previous item on the line (and ignore the item's X coordinate). # This is a Microsoft requirement. # Note that the demographic items are processed and printed # in the same order as the rows below. # Show = 1 to show the field, 0 to hide. # 2 = special case: if the FULL_NAME field uses this 'Show' value of 2, # the first page of the final report will use the corresponding FULL_NAME label and # X/Y coordinates with the combined 'Last, First Middle' name and will # ignore the LAST_NAME, FIRST_NAME and MIDDLE_NAME items for the report. # Otherwise, the final report will use the individual LAST_NAME, # FIRST_NAME and MIDDLE_NAME items and ignore FULL_NAME. FULL_NAME is ignored # by the Patient Information dialog. A value of 2 will be treated as a 1 for all fields # OTHER than FULL_NAME. # The TextLabel can be arbitrary text up to the end of the line. # Everything after the last comma ',' will be part of the label. # # #

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# The lines MUST be entered in the following order: # # SECTION_HEADER Title of demographics section of final report and title of Patient Information # dialog. x and y are ignored but must be present. # # FULL_NAME Used almost everywhere with combined 'Last, First Middle' name. Note that # the label of this item is used in many error messages and dialogs regardless # of whether you use it in the final report or not. # # ID Note: this field will be treated as the patient ID. # # AGE Note: this field will be auto-calculated from the DOB field # if AGE_AUTOCALC is enabled. # # SEX # # REFERRING_PHYSICIAN # # REVIEWING_PHYSICIAN Note: only the label is used in final report - all other fields are ignored. # # INDICATIONS # # MEDICATIONS # # RECORDER_TYPE Note: this field will be automatically filled in by H-Scribe Rx. # # RECORDER_NUMBER # # HOOKUP_TECHNICIAN # # ANALYST # # SCAN_NUMBER Note: this field will be automatically filled in by H-Scribe Rx. # # RECORD_DATE Note: this field will be treated as a date value e.g., DD/MM/YYYY. # # RECORD_START_TIME Note: this field will be treated as a time value e.g., HH:MM:SS. # # SCAN_DATE Note: this field will be treated as a date value e.g., DD/MM/YYYY. # # DOB Date Of Birth - note this field will be parsed to calculate the age # (relative to the recording date) and must be entered in the current # Regional Date format. (see Control Panel | Regional Settings | Date - # e.g., MM/DD/YYYY requires 2 digit month, 2 digit day, 4 digit year) # COMMENT x and y are ignored but must be present. # # AGE_AUTOCALC Note: this field IS used, but the value of Show Item determines whether # Age is auto-calculated from the Date Of Birth field in the Patient Info # dialog. All other information in this line is ignored. # # LAST_NAME used in Patient Information dialog, XML, final report # (see 'Show' field above). # FIRST_NAME same as LAST_NAME. # MIDDLE_NAME same as LAST_NAME. # SECOND_ID same as LAST_NAME. #

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The lines below affect how labels are displayed and aligned when the text file is saved in the Usr directory. -1, 0, 0,6, 0, 0,0,1,Patient Information 0, 0, 0,0, 0, 0,1,2,Name: 1, 0, 1,0, 0, 1,1,1,ID #: 4, 0, 2,1, 0, 2,1,1, Age: 5, 0, 2,1, 0, 2,1,1, Sex: 6, 0, 3,0, 0, 3,1,1,Referring Physician: -1, 0, 0,2, 0, 0,0,1,Reviewing Physician: 7, 0, 4,0, 0, 4,1,1,Indications: 8, 0, 5,0, 0, 5,1,1,Medications: 15,133, 3,2,135, 3,0,1,Recorder: 16,133, 4,2,135, 4,0,1,Recorder No: 10, 0, 6,1, 0, 6,1,1, Hookup Tech: 9, 0, 6,0, 0, 6,1,1,Analyst: 14,133, 2,2,135, 2,0,1,Scan Number: 11,133, 0,2,135, 0,0,1,Date Recorded: 12,133, 0,3,135, 0,1,1,Start Time: 13,133, 1,2,135, 1,0,1,Date Processed: 3, 0, 2,0, 0, 2,1,1,Date Of Birth: -1, 0, 0,2, 0, 0,0,1,Comment: -1, 0, 0,2, 0, 0,0,1,AGE_AUTOCALC 17, 0, 0,0, 0, 0,1,1,Last Name: 18, 0, 0,1, 0, 0,1,1, First Name: 19, 0, 0,1, 0, 0,1,1, Middle Name: 2, 0, 1,1, 0, 1,1,1, Second ID: Hide Demographic Labels 1. Demographic fields can be hidden by changing the number preceding the last comma from 1 to 0. Example: to

turn off Referring Physician change: 6, 0, 3,0, 0, 3,1,1,Referring Physician:

to

6, 0, 3,0, 0, 3,1,0,Referring Physician:

2. Save edited text file as PatientDemographicLabelsV2.txt in appropriate Usr directory.

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Disable Automatic Age Calculation 1. To disable automatic age calculation, change the number preceding the last comma from 1 to 0. Example: -1, 0, 0,2, 0, 0,0,1,AGE_AUTOCALC

to

-1, 0, 0,2, 0, 0,0,0,AGE_AUTOCALC 2. Save edited text file as PatientDemographicLabelsV2.txt in the appropriate Usr directory.

NOTE: When custom ID is not used, age automatically calculates and will update with each DOB change.

Re-align Demographic Labels Patient Information labels, demographic fields, comment fields, and Referring Physician labels can be moved by changing their coordinates and alignment. This is useful when you wish to hide labels and shift another label to the same location; however, use CAUTION as it is possible to overwrite other labels by incorrectly changing coordinates and alignment. Example: to move the Sex field to the Referring Physician location (that was hidden through the steps above), change: 5, 0, 2,1, 0, 2,1,1, Sex 6, 0, 3,0, 0, 3,1,1,Referring Physician: to 6, 0, 3,0, 0, 3,1,1,Sex: 5, 0, 3,0, 0, 3,1,0,Referring Physician:

The Referring Physician field was removed by changing the last value to 0.

The Sex field was moved to the Referring Physician location by changing X from 2,1 to 3,0 and Y from 2,1 to 3,1.

The display order 5 and 6 were reversed.

After the desired changes have been made, save the edited text file as PatientDemographicLabelsV2.txt in the appropriate Usr directory. The results will appear in the final report.

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The example below shows how changes can be made and then saved as PatientDemographicsV2.txt to the Patient List Usr directory:

Default ID Edited Text File Saved to Usr Directory

0,0,6,0,0,0,1,Patient Information 0,0,0,0,0,1,1,Full_Name: 0,1,0,0,1,1,1,ID #: 0,1,1,0,1,1,1, Age: 0,1,1,0,1,1,1, Sex: 0,2,0,0,2,1,1,Referring Physician: 0,0,2,0,0,0,1,Reviewing Physician: 0,3,0,0,3,1,1,Indications: 0,4,0,0,4,1,1,Medications: 0,5,0,0,5,1,1,Recorder: 0,5,1,0,5,1,1, Recorder No: 0,5,1,0,5,1,1, Hookup Tech: 0,5,1,0,5,1,1, Analyst: 150,0,2,152,0,0,1,Scan Number: 150,1,2,152,1,0,1,Date Recorded: 150,1,3,152,1,1,1,Start Time: 150,2,2,152,2,0,1,Date Processed: 150,3,2,152,3,0,1,Date Of Birth: 0,0,2,0,0,0,1,Comment: 0,0,2,0,0,0,1,AGE_AUTOCALC 0,0,2,0,0,0,1,Last_Name 0,0,2,0,0,0,1,First_Name 0,0,2,0,0,0,1,Middle_Name 0,0,2,0,0,0,1,Second ID:

0,0,6,0,0,0,1,Subject Information 0,0,0,0,0,1,1,Initials / Visit: 0,1,0,0,1,1,1, Subject ID #: 0,1,1,0,1,1,1, Years: 0,1,1,0,1,1,1, Gender: 0,2,0,0,2,1,1,Site Location: 0,0,2,0,0,0,1,Reviewing Physician: 0,3,0,0,3,1,1,Protocol: 0,4,0,0,4,1,1,Study Location: 0,5,0,0,5,1,1,Recorder: 0,5,1,0,5,1,1, Recorder No: 0,5,1,0,5,1,1, Hookup Tech: 0,5,1,0,5,1,1, Analyst: 150,0,2,152,0,0,1,Scan Number: 150,1,2,152,1,0,1,Date Recorded: 150,1,3,152,1,1,1,Start Time: 150,2,2,152,2,0,1,Date Processed: 150,3,2,152,3,0,1,Date Of Birth: 0,0,2,0,0,0,1,Interpretation: 0,0,2,0,0,0,1,AGE_AUTOCALC 0,0,2,0,0,0,1,Initials: 0,0,2,0,0,0,1,Visit #: 0,0,2,0,0,0,0,Middle_Name: 0,0,2,0,0,0,1,Study Number:

NOTE: Middle Name field will be hidden.

Full Name Field Full_Name will print on the final report and appear in exported statistic XML files by grouping Last_Name, First_Name, and Middle_Name fields. Last_Name, First_Name, and Middle_Name fields can be customized with other desired labels; all fields will be combined as the Full_Name when “Show” is set to a value of 1. When “Show” is set to a value of 2, the first page of the final report will use the Full_Name label with combined Last, First, and Middle name and X,Y coordinates only. Be sure to review your output when changing these fields to ensure the results are as expected.

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When a Holter ECG is exported to E-Scribe, these fields will also appear in the “Patient Name” field in the E-Scribe Rx ECG file. The results of your changes will appear in the following locations. Patient Information:

Select Patient:

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Report Preview and Final Report:

Rx XML Export Statistics:

NOTE: Each demographic field name shows the original H-Scribe Rx label, the current label, and its value. The original label reflects the intended meaning which may have been changed through custom ID.

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Export File Name Format Setup The naming convention for exported files can be configured as desired. This feature is advantageous when the receiving device requires a specific file name format. A configuration file can be used to change the default file name formats of the following export types. The lines in the configuration file are ordered as follows:

1. Audit Trail PDF and TXT beat log 2. Interface Export PDF and XML Statistics 3. Rx XML Statistics 4. Rx XML Strips 5. PDF Only Export

The following file name configurations exist as H-Scribe Rx defaults; no changes are required for enabling them. Audit Trail file name formats are: H^<type>_<patientlist>^<slot#>_<id>^<lname>^<fname>^<mname>_<startime>_<exporttime>.pdf H^<type>_<patientlist>^<slot#>_<id>^<lname>^<fname>^<mname>_<starttime>_<exporttime>.txt

The file name format for each Interface Export file exported via Interface.dir is constructed as: H^<type>_<patientlist>^<slot#>_<id>^<lname>^<fname>^<mname>_<starttime>_<exporttime>.xml H^<type>_<patientlist>^<slot#>_<id>^<lname>^<fname>^<mname>_<starttime>_<exporttime>.pdf

The file name format for each PDF only file exported via Browse.dir is constructed as: H<id>[starttime]<fname>_<mname>_<lname>.pdf

The file name for each Rx XML file is constructed as: H^<type>^<format>^<duration>_<patientlist>^<slot#>_<id>^<lname>^<fname>^<mname>_<starttime>_<exporttime>.xml

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The configuration file ExportFilenameFormats.txt can be used to format output file names to control each of the export file types shown above. There are several rules and requirements when using this file to customize output file names: - Each non-blank line must contain a file name format containing one or more of the directory path specifiers:

default output path, patient directory, root directory for the patient, or root directory for the current patient list. - The file name format string on each line of the ExportFilenameFormats.txt file must not contain a file extension

(e.g., .txt, .pdf, .xml). File extensions will be appended as appropriate for the given file being exported. - All user-entered text used to replace the format specifiers will be filtered to remove illegal characters (e.g., * ? <

> “ / | \ :). # is removed because it interferes with web page bookmark navigation. Periods (.) are removed because they interfere with the file name extension. ^ and _ are removed because these are reserved separators. All illegal characters will be replaced with a hyphen (-).

- Format specifier names are case sensitive (e.g., PatientLastName not PATIENTLASTNAME). - The ExportFilenameFormats.txt file is supported by ConfigurationFileLocations.txt and can be configured

locally, centrally, or per patient list. - The ExportFilenameFormats.txt file overrides the AuditTrailPath.txt, Browse.dir, XML.dir, MGateConfig.ini,

and Interface.dir paths unless the format specifier <DefaultPath> is used. - If the ExportFilenameFormats.txt file does not exist or the line corresponding to the specified export type is

blank, the default path and file name for the given export file type will be used. - File name uniqueness is enforced for all file types except PDF only. When the file already exists H-Scribe Rx

will wait up to 5 seconds to allow the report date and time to change when <ReportDateTime> or <DefaultFilename> are used. This prevents overwriting of files except for PDF only files.

Examples:

Specifies a fixed output directory for all exports of that export type: \\Server\ShareName\ExportDir\<DefaultFilename>

Changes all export filenames of that export type to be the patient full name (Last, First Middle): <DefaultPath>\<PatientFullNameLFM>

Changes all exports of that export type to go to the current patient directory, with the file names containing first name, last name, ID, and recording date/time: <PatientDir>\<PatientFirstName>^<PatientLastName>^<PatientID>^<TestDateTime>

Changes all exports of that export type to go to a network directory, with the file names containing a fixed protocol name, the Patient List name, the file type: \\Server\ShareName\ExportDir\ProtocolXYZ_<PatientListName>_<FileType>

All exports of that export type to go to a common directory specific to each Patient List: <PatientListDir>\ExportDir\<DefaultFilename>

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File name format specifiers are shown in the table below:

Filename Format Specifier Usage

<DefaultPath> Default output path for the file

<PatientDir> Current patient directory

<PatientRootDir> Root directory for the current patient

<PatientListDir> Root directory for the current patient list

<DefaultFilename> Default file name for this file type with extension

<PatientID> Current patient ID

<PatientSecondID> Current patient second ID

<PatientFullNameLFM Last, First Middle patient name

<PatientLastName> Patient last name

<PatientFirstName> Patient first name

<PatientMiddleName> Patient middle name

<PatientSex> Sex where M = Male, F = Female, U = Unknown

<TestDateTime> Start date and time of the recording *

<TestDate> Start date of the recording **

<ScanDate> Date the recording was last scanned **

<ReportDateTime> Current date and time of file export creation *

<ReportDate> Current date of file export creation **

<PatientDOB> Current patient date of birth **

<PatientListName> Name of the current patient list

<FileType> File type indicator ***

<SlotNumber> Value of the patient directory slot number

* Date and time in HL7 YYYYMMDDHHMMSS format ** Date in HL7 YYYYMMDD format *** Refer to file type explanations in sections of this user manual (e.g., STAT for XML Statistics)