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, HScribe, Surveyor, and VERITAS are trademarks of Mortara Instrument, Inc. Microsoft and Windows
are registered trademarks of Microsoft Corporation.
Page 3
TECHNICAL SUPPORT AND SERVICE
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 Rangoni Europe, Srl
(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
24-hour Technical Support
Same-day Shipment of Replacement Parts
Biomedical Training Classes
Extended Warranties/Service Contracts
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
E-mail: sales@mortara.com
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.
ii
Page 5
WARRANTY INFORMATION
Your Mortara Warranty
MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products
(hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use,
service, and maintenance for the warranty period of such Product/s from Mortara or an authorized distributor or
representative of Mortara. The warranty period is defined as twelve (12) months following the date of shipment
from Mortara. Normal use, service, and maintenance means operation and maintenance in accordance with
appropriate instructions and/or information guides. This warranty does not apply to damage to the Product/s caused
by any or all of the following circumstances or conditions:
a) Freight damage;
b) Parts and/or accessories of the Product/s not obtained from or approved by 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 Mo rtara shall be limited to the lesser of the actual loss, harm, or
damage, or the original purchase price of the Product/s when sold.
EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH
AS PAPER, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, ELECTRODES,
PATIENT CABLES, LEAD WIRES, AND MAGNETIC STORAGE MEDIUMS.
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.
iii
Page 6
WARRANTY INFORMATION
iv
Page 7
USER SAFETY INFORMATION
Warning:
Caution:
Note:
Means there is the possibility of personal injury to you or others.
Means there is the possibility of damage to the device.
Provides information to further assist in the use of the device.
Warning(s)
•This manual gives important information about the use and safety of this device. Deviating from operating
procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could
result in increased risk of harm to users, patients and bystanders, or damage to the device.
•Device (Holter analysis system) 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.
•Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient
care, and adequately trained in the use of this device. Before attempting to use th is device for clinical
applications, the operator must read and understand the contents of the user manual and other accompanying
documents. Inadequate knowledge or training could result in increased risk of harm to users, patient and
bystanders, or damage to the device. Contact Mortara service for additional training options.
• 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 associated safety standards.
• To maintain operator and patient safety, only use parts and accessories supplied with the device and available
through Mortara Instrument, Inc.
• 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.
• Do not operate the device if it has been damaged. Have damaged equipment repaired by qualified personnel.
Contact Mortara service for assistance.
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Page 8
USER SAFETY INFORMATION
Caution(s)
• Loading or operating commercially available software might affect the performance of the device.
• 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 alcohol-free sterilizing disinfectant avoiding aggressive detergents;
dry with a clean cloth. Use of unspecified cleaning/disinfecting agents, failure to follow recommended
procedures, or contact with unspecified materials could result in increased risk of harm to users, patients and
bystanders, or damage to the device.
• Recordings that are saved to the local or server database on the hard drive will cause the device to fill over a
period of time. These recordings must be removed from the database by deleting or archiving prior to causing
the device to cease to operate. Periodic checks of the device’s capacity are recommended; a safe minimum
capacity capacity is 10 Gb. See Section 7 "Exam Search" for ways to select recordings for deletion or
archiving.
• System environment: It is the user’s responsibility to use, transport, and store the device in conditions that are
compatible with the components of the system (PC, printer, display, etc.).
• Separate instructions for storage, use and disposal are included with the computer, display and printer. Read
and follow these, and keep them available for consultation.
• Windows compatibility, updates and anti-virus policy: The HScribe software has been fully tested with
Windows 7 Service Pack 1. Although it is unlikely that Windows updates and security patches affect HScribe
functionality, Mortara recommends turning automatic Windows update off, and periodically running it
manually. A functional test should be executed after update, which includes acquiring a recording, editing and
printing a report, as well as importing an order and exporting results, if activated. Compatibility of HScribe
with major corporate anti-virus software packages has been verified. Mortara recommends excluding the
HScribe database folder (Normally C:\ProgramData\MiPgSqlData on a stand-alone system or the server) from
the folders to be scanned. In addition, anti-virus patch updates and system scans should be scheduled for time
periods when the system is not actively in use or performed manually.
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.
• When necessary, dispose of the device, its components and accessories and/or packing materials in accordance
with local regulations.
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Page 9
EQUIPMENT SYMBOLS AND MARKINGS
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
Indications for Use ........................................................................................................................................................ 1
System Description ........................................................................................................................................................ 2
Interacting with Windows Environment ........................................................................................................................ 2
Login and Main Display ................................................................................................................................................ 3
Program Icons ................................................................................................................................................................ 4
User Roles and Permissions .......................................................................................................................................... 5
Manage User Accounts .................................................................................................................................................. 7
Manage/Create Groups .................................................................................................................................................. 8
Service Logs ............................................................................................................................................................... 11
Front Bezel Removal ................................................................................................................................................... 17
Printer Information ...................................................................................................................................................... 21
Unable to Detect H12+ CF Card ................................................................................................................................ 23
Unable to Detect H3+ Recorder .................................................................................................................................. 23
Scan and Fix Message Appearing ............................................................................................................................... 24
Unable to Acquire Data from Surveyor Import ........................................................................................................... 25
Unable to Access MWL .............................................................................................................................................. 26
Schedule Order .............................................................................................................................................. 27
Review and Edit Recording ........................................................................................................................... 28
Print Final Report .......................................................................................................................................... 28
Export Data ................................................................................................................................................... 29
Test Data Record ......................................................................................................................................................... 30
Fetch All Config .......................................................................................................................................................... 34
System Backup ............................................................................................................................................................ 37
System Restore ............................................................................................................................................................ 39
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INTRODUCTION
SECTION 1
Manual Purpose
This manual is intended to provide the user with information about service related activities associated with the
HScribe™ Holter analysis system and the following functions:
• Device Specifications
• Troubleshooting
• Conformance Testing
• System Utilities
• System Backup and Restoration
Audience
This manual is written for service technicians who are expected to have a working knowledge of electrical and
mechanical repair techniques, computer skills, and terminology as required for servicing medical devices.
Indications for Use
The HScribe 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
• Evaluation of infant patients, including those weighing less than 22 pounds or 10 kilograms, limited to
QRS detection and heart rate reporting only
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SECTION 1
System Description
HScribe is a high-speed, PC-based Holter scanner. Used in conjunction with Mortara Instrument’s H3+™ and
H12+™ digital Holter recorders, the HScribe provides full-disclosure data for arrhythmia analysis, and
incorporates Mortara Instrument’s exclusive VERITAS™ ECG algorithms for superior beat detection and
ST segment analysis on all recorded leads to acquired recorded ECG data. ECG data from an H3+ or a compact
flash (CF) memory card is downloaded for analysis to the HScribe. After acquisition the recorder or CF
memory card is erased and prepared for the next recording session using the HScribe application software.
The HScribe system is available as a single workstation system with a centralized exam database that can
support networked HScribe Review and HScribe Download workstations; or in a distributed configuration
where the database resides on server hardware supporting a number of networked HScribe workstations.
The HScribe review station offers equivalent review, editing and reporting capabilities to the HScribe excluding
data acquisition. Holter ECG recordings are acquired at the HScribe or a networked download station.
The HScribe download station allows either recorder or CF memory card data acquisition and erasure, entry of
patient information, automatic scanning, and archive to external or network drive. It does not review ECG data.
Recordings must be reviewed at any networked HScribe 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. Full-disclosure patient monitoring data can be imported into the HScribe for Holter an alysis
through the use of the HScribe Surveyor Import application.
H3+ and H12+ Holter recordings can be acquired from a web server when they have been uploaded from a
remote location with the HScribe Web Upload option.
Report formats include scan criteria, tabular and narrative report summaries, rhythm profiles, 24-hour or
48-hour trends of all arrhythmias, QT/QTc and ST segment values, template pages, automatic and operatorselected strips with one, two, three, or twelve-lead ECG, and full disclosure of selected channels. HScribe
supports a paperless workflow with user verification and an option for electronic signature.
Multiple recordings with analyses are stored in the HScribe database in a central location. Users with the
appropriate permissions can import a new recording or review existing analyses.
User access to HScribe is defined by the system administrator allowing the ability to modify patient
demographics, report conclusions, diary events and Holter ECG data editing. HScribe access is controlled by
each user’s role (e.g. IT administrator, Clinical Administrator, Physician Reviewer, Holter analyst, etc.) and
associated permissions.
Long-term storage of full-disclosure patient recordings is accomplished by the archive feature. Archived Holter
recordings can be restored to the HScribe database for further analysis, review, report export, and printing.
An audit trail allowing administrative personnel to query details for user actions and operations is maintained by
HScribe.
The HScribe system layouts and contents are customizable for both display and final reporting. Contact
Mortara Customer Service for more information.
Interacting with Windows Environment
HScribe is based on a Microsoft
Conforming to Windows’ intuitive “graphical user interface,” the HScribe 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.
®
Windows® operating system and runs on an industry-standard platform.
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Login and Main Display
If not set up with a single sign on, HScribe will
require user credentials on startup. The default
factory username and password is admin (password
is case sensitive).
SECTION 1
Upon successful login, the HScribe application screen
will appear displaying the user name and software
version in the bottom left corner. Click on any of the
icons representing workflow to perform a specific
task.
Hover over an icon to display the icon’s function.
Icons not permissible to the user are grayed and not
available.
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Program Icons
Icon/Function Description
Desktop shortcut icon to launch the Holter modality application.
Use to schedule an exam and/or review the exam schedule.
Schedule/Orders
Prepare Recorder/Card
Import Recordings
Worklist
This icon is only available when HScribe is not linked to an external scheduling
system.
Use for compact flash (CF) card or recorder erasure and preparation for the next
exam.
Use to display connected devices (CF card, recorder, web upload, and Surveyor
data folders) allowing association of patient demographic data and ac quisition.
Use to display exams with a preset filter showing only Acquired, Edited, or
Reviewed status according to user preference and permissions. Checkboxes
allow for further filtering.
SECTION 1
Use to search for Holter exams in the database using filters.
Exam Search
Use to search for patients in the database using filters and to edit patient
Patient Search
User Preferences
System Configuration
Exit
demographics.
Use to configure user preferences for the Worklist and to change the password.
For administrative users to configure system settings such as
creating/modifying users, changing the HScribe default scan criteria, defining
archive directories, and so on.
Use to close the HScribe application and return to the desktop.
Use to minimize or exit the application and return to the desktop.
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SECTION 1
User Roles and Permissions
HScribe supports a workflow-oriented setup for defining user roles and controlling user access to the various
operations. Role assignments are comprised of a set of permissions for each user type (e.g. IT administrator,
clinical administrator, Holter Hookup Tech, and so on).
Each user can be assigned a single role or a combination of roles. Some roles will include permissions assigned
to other roles where applicable.
Roles Permission Assignment
IT Administrator Manage user permissions; manage personnel lists; export settings; Web upload
and Surveyor data folders; archive settings; workflow configuration; storage
system configuration; unlock exams; view audit trail reports; export service logs.
exams offline to share with Mortara personnel or other sites; view audit trail reports;
modify modality settings (scan criteria defaults and other Holter specific settings);
reconciliate; export service logs; create and modify groups.
Schedule Procedure Create new patient orders; associate an order with an existing patient; modify
demographics of an existing patient; export service logs.
Scheduling and order entry is only available when HScribe is not linked to an
external scheduling system.
Patient Hookup Start and import new recordings using the Import Recordings icon. Includes the
ability to prepare recorder/card and create a new patient; associate an order or
recording with an existing patient; create and modify diary events; export service
logs.
Edit Holter Diary Create and modify diary events; export service logs. Must be assigned in
conjunction with another role (e.g. Review Report).
View Exams/Reports Review exams and final reports only. Includes the ability to search exams, view
and print reports; export service logs.
Prepare Report Review and edit exams to move them to the edited state. Includes ability to search
exams and view and print reports; export service logs.
Review Report Review and edit exams to move them to the reviewed state. Includes ability to
search exams and view and print reports; modify and create conclusions; export
service logs.
Edit Conclusions Create and modify conclusions. Includes ability to review exams and final reports
only; search exams and view and print reports; export service logs.
Sign Report Ability to move exams to a signed state. Includes ability to review exams and final
reports; search exams and view and print reports; export service logs.
Export Report Ability to export a PDF, XML and/or waveform strips when features are enabled.
Must be assigned in conjunction with another role (e.g. Review, View, or
Conclusions).
Feature Activation
An activation code is required to operate full HScribe software functions such as acquisition, network access,
storage, archiving, and export. Without activation, the system will function for a period of fourteen days only.
Contact Mortara Technical Support personnel for information.
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Specifications
Feature Workstation Minimum Specifications*
Processor Performance equivalent to an Intel Core i3
Graphics 1280 x 1024 (1920 x 1080 recommended)
RAM 4 GB
Operating System Microsoft Windows 7 Professional 32-bit or 64-bit (required)
Storage Capacity 160 GB
Archive Network or external USB drive
Input Devices USB Standard keyboard and 2-button scroll mouse
DVD Drive CD-ROM
Network 100 Mbps connection or better
Printing Device HP PCL5-compatible printer series (recommended)
USB Ports 2 free USB 2.0 ports
SECTION 1
* Specifications subject to change without notice.
Feature Server Minimum Specifications*
Processor Performance equivalent to an Intel Xeon class; Quad-core with
hyperthreading
Graphics 1024 x 768
RAM 4 GB
Operating System Microsoft Windows 2008 server R2, 64-bit (required)
System Disk 100 GB for OS and product installation (RAID recommended for data
redundancy)
Data Disks 550 GB hard drive space available
HD controller with 128 MB read/write cache
(RAID recommended for data redundancy)
Archive Network or external USB drive
Software Installation CD-ROM
Network 100 Mbps connection or better
Input Devices Standard keyboard and mouse
* Specifications subject to change without notice.
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SYSTEM AND USER CONFIGURATION
Administrative Tasks
The IT and Clinical Administrator user will select the System Configuration
icon to enter the HScribe administrative functions. All other users can enter this
menu to access the Export Service Log task only.
A list of administrative tasks is presented to:
• Manage user accounts
• Manage personnel lists
• Manage Groups
• Manage archived exams*
• View audit trail logs
• Export service logs for troubleshooting purposes
• Configure system-wide modality settings
• Configure DICOM data exchange
• Configure XML and PDF data exchange
• Configure workflow
• Unlock exams
• Configure Web Upload file location for import
• Configure Surveyor Data file location for import
SECTION 2
* Task may not be available when operating with DICOM.
Manage User Accounts
User’s Database
The IT administrator will select User’s
Database to create or remove user
accounts, reset user passwords, assign
permissions for each user, and assign
personnel entries for that user’s
selection. When a single sign-on is
used, no user account and password
creation is needed.
Personnel
Personnel is selected to add personnel
that will be available in the Patient
Information, Summary, and the Finalize
Exam Update windows. Listed
personnel can be assigned to each user
account and will appear as selections for
the logged-in user and in the appropriate
final report fields.
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SECTION 2
Manage/Create Groups
Groups allow the administrator to group exams according to reporting preferences (modality settings) and file
exchange preferences. A single default group exists that can be copied and saved with a new name to create a
second group. Select Groups to make a change. Any created group can be copied, renamed and modified. The
Default group can be renamed. An unlimited num ber of gr ou ps can be creat ed and m odified.
HScribe Modality Settings, File Exchange paths, Web Upload directory paths, and Surveyor Data import paths can
be uniquely defined for each individual group.
Groups, with exception of the Default gr ou p, can be dele ted resulting in deletion of all exams that exist within the
deleted group.
Modality Settings
HScribe modality settings are defined as default by the clinical administrator and are available for the user with
editing permissions. The analyst is able to modify these settings on a per exam basis. Select the tab you wish to
modify and click on Save Changes or Discard Changes to cancel changes before exiting.
ECG Strips
ECG strip annotations available for selection when adding a strip to the final report can be added, removed, and
moved up or down in the list.
One, two, three, or 12 leads can be selected as a default for auto-strips settings selection for the final report.
Periodic strips can be set every HH:MM:SS as well as a set offset for the first strip. ECG strips with lead failure can
be excluded by checking the Skip Lead Fail checkbox.
Scan Criteria
Scan Criteria default settings are defined under this tab. Factory settings can be modified as desired and saved for
all recordings imported after saving. Current recordings will retain the set Scan Criteria at the time of import.
Supraventricular (SVPB) prematuri t y percent , pau se, ST e levat i on an d depression, tachycardia and bradycardia
thresholds are defined in this window. Determination to consider a pause using all beats, or only normal -t o- no rmal
beats is selected with a radio button. Beat types to be used for heart rate and Heart Rate Variability calculations are
selected in this window. Atrial Fibrillation automatic detection is enabled/disabled in this window. Pacemaker
Analysis is not available for selection as a default, although it is shown in this window.
Diary
Diary annotations available for selection when editing diary entries can be added, removed, and moved up or down
in the list.
Event Labels
Event labels available for selection when identifying an ECG event in the recording can be added, removed, and
moved up or down in the list. A maximum of three event labels selected from the Event Labels listing can be
identified as default in this window.
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SECTION 2
QTc
The default formula choice for QTc Linear, Bazett, or Fridericia is chosen in this window with a radio button.
Three user-selectable choices for RR intervals to be used for QTc calculation are selectable by radio button.
Choices are RRprior (previous RR interval in milliseconds), RR16 (sum of the previous 16 RR intervals), and RRc
(weighted average of the past 256 RR intervals).
File Exchange
HScribe supports the ability to import orders from XML files and export PDF and XML results to an external
system dependent on the system activated features. Import/Export directories for the selected group are defined in
the File Exchange window. An E-Scribe Site Number is also defined in this window when applicable. Refer to
the Scribe Data Exchange Administrator Manu al (P/N: 9515-185-51-ENG) for external system integration details.
Standard Export
Systems configured with standard export options will always export XML V5 Holter Statistics and a PDF copy of
the final report to the defined destination.
RX Export
Systems configured with RX export options will always export XML V5 RX Holter Statistics and can optionally
export Holter ECG strips with waveform in Mortara XML format, Holter ECG strips with waveform in FDA XML
format, UNIPRO32 12-lead ECG strips and a PDF copy of the final report to the defined destination.
PDF File Name
The final report PDF file name will have the following structure:
HScribe supports the ability to exchange information with DICOM systems dependent on the system activated
features. A DICOM Modality Worklist (MWL) will be received from the DICOM server. A DICOM encapsulated
PDF will be exported to the defined destination. Refer to the Scribe Data Exchange Administrator Manual
(P/N: 9515-185-51-ENG for DICOM connectivity configuration details.
Web Upload/Surveyor Folders (WU/Serv)
HScribe supports the ability to import Web Upload server recordings and Surveyor Central system monitoring data
dependent on the system activated features. The Web upload and Surveyor import paths are defined within this
selection.
The Windows user running HScribe must have read/write access to the directories. Select the Path field and select
Browse to navigate to the appropriate directory, or enter the path manually. Click Add to include the path for the
selected group.
Web upload and Surveyor data paths can be removed by highlighting the path and selecting Delete.
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SECTION 2
Web upload and Surveyor paths can be authenticated using Validate. When the path is not valid a red exclamation
mark is displayed next to the path field.
Unlock Exams
HScribe internally tracks transitioning exams preventing the same exam to be processed by two or more users.
When a second user attempts to access an exam in use, a m essage displays with notification that the exam is not
currently available.
As a measure for recovering locked exams, administrative users can unlock an exam that resides on the same
workstation by selecting Unlock Exams. Highlight the listed exam(s) and click on Unlock.
Manage Archive Storage
The HScribe administrative user will manage storage system disks through selection of Storage System.
Add Archive Location
Select Mount Remote Disk to open a window allowing entry of a path to the archive directory destination. Any
external disk (e.g. NAS, USB, etc.) accessible from the HScribe central database is a candidate for becoming an
archive volume. A Username, Password and Domain must be entered to Add the new storage disk to the Available
Disks listing. Select Cancel button to exit this window without saving changes.
Restore Archived Exams
Administrative users can restore exams from the archive location to the HScribe database through selection of
Archive Recovery. Once selected, a window will open listing exam archive date and time, archive name, volume
name, volume ID, and drive letter of the archive volume. To restore exams, highlight the desired exam(s) in the list
and click on Recovery. Multiple exams can be restored by highlighting them and then a single Recovery button
click.
Search can be used to find exams matching alphanumeric text entry. Column headers can be selected to sort listed
exams by that item.
Audit Trail Logs
The HScribe administrative user will select Audit Trail to view the audit trail history. A selection of filter criteria
is available to sort the listing by date, user, workstation, operation, or target (e.g. User, Patient, Exam, Conclusion,
Locked Exams, User and System Settings). One or two filter criteria can be used to find audit trails.
Selection of results will display the differences by comparing the XML statistics data before and after changes. A
legend with colored highlighting will point to added, removed, changed, and moved information.
All configuration information, user information, patient demographic information, exam demographic information,
textual conclusions, archive operations, and exam download requests are tracked by the audit trail.
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SECTION 2
Service Logs
All HScribe users have access to Export Service Logs. Selection of the button creates a Win-7 zipped file that
can be sent to the desktop containing a copy of the system logged events.
The file named EMSysLog.xml.gz can be e-mailed to a Mortara service representative for troubleshooting
purposes.
Configure Workflow
The HScribe exam states are designed to follow typical user workflow. There are six possibilities with meanings
defined below each state:
1. ORDERED
The Holter exam is either scheduled by a user or an external scheduling system has sent an order.
2. IN PROGRESS
The Holter recorder or CF card has been prepared and is in process of recording patient data at the
acquisition device.
3. ACQUIRED
The recording device has completed data collection and the recording has been imported at the HScribe
system and is ready for scanning.
4. EDITED
The Holter recording has been analyzed with or without changes to the computer analysis and is ready for
review by a physician. Conclusions may be entered at this state.
5. REVIEWED
The Holter recording has been reviewed and confirmed to be accurate by an authorized user (e.g. physician,
fellow, clinician, etc.). Conclusions may be entered at this state.
6. SIGNED
The exam is reviewed and electronically signed by an authorized user. No further workflow processing is
required. Conclusions may be entered at this state.
The user with appropriate permissions is prompted with a Final Exam Update dialog to confirm or Update the
next logical state when exiting a Holter exam. A drop-down menu allows selection of a state in respect to the
exam’s current state. Cancel may be selected to discard any change to the state.
Workflow Config
A Legal Signature can be enabled by selecting Yes or disabled by
selecting No.
include all, or exclude some states through selection of Workflow Config.
Administrative users can configure the workflow to
• Select All under Modality Status to enable all six states.
• Select No REVIEWED under Modality Status to move the state from EDITED to SIGNED.
• Select No EDITED/REVIEWED under Modality Status to move the state from ACQUIRED to SIGNED.
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SECTION 2
About the Legal Signature
The legal signature requires the user credentials prior to updating a Holter exam when changing to a signed state.
When enabled, the user is prompted to authenticate with a user name and password when transitioning to the signed
state. Authentication can be entered when a different user is currently logged in. When the correct credentials are
not entered, the user will be notified with a message that the “Credentials supplied are not valid.”
When the signing physician has been set up as an Attending Physician under Personnel, the printed name will appear
in the Holter final report on the signature line following the “Electronically Signed By:” field label.
User Preferences
Select the User Preferences icon to open the window. Set selections define the default criteria for the Worklist
when the particular user is logged into HScribe. Set selections can be changed when the user enters the Worklist
window. The user can also change the password in this window when the system is not set up with a single sign-on.
All users have access to the User Preferences settings but may not have the Worklist available. Those users will
only enter this window to change their own password.
There are three possible choices for the Worklist Holter Exam states that can be enabled or disabled by checkboxes.
The choices are dependent on the workflow configuration modality status setting in that Edited or Review may not
appear as selections.
1. Acquired
2. Edited
3. Reviewed
There are three choices for a default time filter.
1. All
2. Today
3. Today, Yesterday and Tomorrow
When finished, select OK to save changes or Cancel to exit the window without saving changes.
HScribe will present the default settings on any of the workstations that the user logs into.
Report Configuration Tool
HScribe final reports should be configured with the practice name, address, and phone number prior to using the
system. The practice logo and default sections for final report inclusion are also customizable within this tool.
Click on the HScribe workstation Start menu. Choose All Programs, Mortara Instrument, Inc. followed by
Report Configuration Tool to open a dialog window prompting a Group choice from a drop-down list. Each
group that has been defined will have its own report configuration.
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Click on the Start Wizard button to open the tool. The Exit button will close the tool.
SECTION 2
Configuring the Final Report
Once the tool is opened, the following can be performed:
1. Hide final report sections by checkbox selection in the Report Configuration Tool. When the box is
checked, the section is disabled as a default; however, the section can be enabled for printing and export
when previewing the final report for each ind i vi dual pat i e nt.
2. Add or Remove a logo image for the HScribe final report header. The Stretch checkbox causes the logo
to fit into the header area appropriately.
3. Enter institution contact information under the Practice section.
When finished, click on Next > and then Finish. <Back allows you to return to the previous screen; Cancel
prompts you with an “Are You Sure” message. Select Yes to cancel the changes.
Once finished, the Group selection is still available for you to
choose the next group to repeat the steps listed above. When
done defining all groups, select the Exit button.
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SECTION 2
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UNIT DISASSEMBLY
SECTION 3
Before you begin
1. Put on your electrostatic discharge (ESD) wrist strap to avoid damaging any circuitry.
2. Remove all devices (such as diskettes and CD-ROMs) from the computer.
3. Power off the computer and any peripheral devices that are connected to it.
4. Disconnect the power cord from the electrical outlet and then from the computer. When the
computer is plugged into an AC power source, there is always voltage applied to the system
board. You must disconnect the power cord from the power source before opening the computer
to prevent system board or component damage.
5. Disconnect all peripheral device cables from the computer.
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UNIT DISASSEMBLY
SECTION 3
Static electricity
Static electricity can damage electrical components. Before removing or replacing a component, touch a
grounded metal object to discharge static electricity. Also observe the following precautions to prevent
damage to electric components and accessories:
To avoid hand contact, transport product s in stat i c -safe containers such as tubes, bags, or boxes.
Protect all electrostatic parts and assemblies with conductive or approved containers or packaging.
Keep electrostatic-sensitive parts in their containers until they arrive at static-free stations.
Place items on a grounded surface before removing them from their container.
Always be properly grounded when touching a sensitive component or assembly.
Avoid contact with pins, leads, or circuitry.
Place reusable electrostatic-sensitive parts from assemblies in protective packaging or conductive
foam.
Disassembly
During disassembly, label each cable as you remove it, noting its position and routin g. This will
make the replacement of the cables much easier, and will ensure that the cables are rerouted
properly to protect the cables.
Keep all screws with the units removed. The screws used in the computer are of different thread
sizes and lengths; using the wrong screw in a component could damage the unit.
Access panel removal
1. Review the safety considerations before performing the steps listed below by clicking on the
following
CAUTION:
2. Pull up and hold the access panel release latch.
3. Rotate the panel up and lift it away from the chassis.
Failure to comply with the precautions could result in damage to your product or loss of data.
To install the computer cover, reverse the removal procedure.
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UNIT DISASSEMBLY
Front Bezel
1. Prepare the computer for disassembly
2. Remove the access panel
3. Lift up the three tabs on the side of the bezel (1), then rotate the bezel off the chassis (2).
Removing the Front Bezel (shown with optical drive installed)
SECTION 3
To install the new front bezel, reverse the removal procedure.
Front Bezel Security
The front bezel can be locked in place by installing a security screw provided by HP. To install the
security screw:
1. Prepare the computer for disassembly
2. Remove the access panel
3. Remove the front bezel
4. Remove one of the five silver 6-32 standard screws located on the front of the chassis behind
the bezel.
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UNIT DISASSEMBLY
Retrieving the Front Bezel Security Screw
SECTION 3
5. Replace the front bezel.
6. Install the security screw next to the middle front bezel release tab to secure the front bezel in place.
To remove the front bezel security screw, reverse the installation procedures.
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UNIT DISASSEMBLY
HScribe 5 - Item Identification Table
Mortara Item # Description
25019-006-50 CABLE ASSEMBLY USB H3+
6400-012 CABLE USB TYPE A-TO-B FULL SPD (Printer)
9900-014 MONITOR 24" LCD 1920x1200 WIDE DVI + VGA
9903-013 DRIVE COMPACT FLASH EXTERNAL
9903-030 MOUSE 2-BUTTON w/SCROLL WHEEL USB
9906-037 CPU LONG LIFE w/WINDOWS 7 (
9907-016 PRINTER HP LASERJET USB + NETWORK
SERV PART 184-01 LONG LIFE PC POWER SUPPLY
SECTION 3
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UNIT DISASSEMBLY
SECTION 3
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TROUBLESHOOTING
Computer Faults
Dual colored power LED on front of computer to indicate either normal or fault condition
Diagnostic LED Explanation Table:
Number of 1-second red LED blinks followed by a 2-seco n d pau se, t hen repeat s:
2 – processor thermal protection activated
3 – processor not installed
4 – power supply failure
5 – memory error
6 – video error
7 – PCA failure (ROM detected failure prior to vide o)
8 – invalid ROM, bootblock recovery mode
9 – system not fetching code
10 – system hang while loading an option ROM
Printer Information/Settings
Driver: HP Universal Printing PCL5 (V5.4)
Recommended Raster Graphics Printer Setting:
To change the printer settings, click on <start>, then <Devices and Printers>
SECTION 4
Right click on the appropriate printer. Select <Printer Properties>
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TROUBLESHOOTING
Click the Preferences button.
SECTION 4
From the Advanced Tab, set Graphics Mode to: Send Graphics as Raster
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TROUBLESHOOTING
SECTION 4
HScribe Application
Upon completion of installing software, Program Icons (grayed out) not able to access function.
You must click on the system configuration Icon and setup User preferences (To configure user
preferences to setup permissions to these functions).
Reference operator’s manual for more details.
Unable to detect flashcard media
Check to ensure flashcard has volume label of: Mortara_H12
• From Windows explorer, right click on drive that has the CF card installed.
• Go to properties and check volume label
• Close Windows explorer.
Unable to detect H3+ recorder
• Ensure that the AAA battery is removed prior to USB download cable connection
• Is recorder listed in the Recording List in Hscribe?
• Is USB displayed on the H3+ display when connected to PC?
o Check to ensure proper connection is made at the PC and at the recorder.
o Check for damaged connector on cable and recorder.
• Is recorder listed in Windows explorer? It should be displayed as Mortara_H3.
• Close Windows explorer. (Contact Technical support)
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TROUBLESHOOTING
Windows “Scan and Fix” Message Appearing when CF card/Recorder connected
SECTION 4
If the message above appears when inserting a CF card of H3+ recorder each time, and the system
administrator would like to disable this message, the following steps can be performed.
Note – Disabling this feature will apply to all newly connected hardware devices and the decision to
disable the feature should be considered in the context of the facility IT security policy.
From the Services menu, select “Shell Hardware Detection”. When the window below appears, change the
“Startup Type” from Automatic to Disabled.
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TROUBLESHOOTING
SECTION 4
Unable to acquire Data from Surveyor Import
Click on system settings
Click on WU/Surv Folders and set the path to the location set in Surveyor Import. (E.g. C:\Surveyor data)
Verify data appears in recording list to import data
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TROUBLESHOOTING
SECTION 4
Unable to access MWL:
Open system configuration
Proceed to the MWL settings tab and ensure the information is correct.
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CONFORMANCE TESTING
SECTION 5
Conformance Testing
Conformance testing is to be performed by Authorized Mortara Service Representatives to verify
the device is functioning correctly after repair operations have been performed. System must be
configured prior to tests. Testing results can be documented on the test data record provided at
the end of this section of the manual.
Required Equipment:
• H3+ recorder or H12+ CF card with prev iously recorded data
• Legacy recordings <Where applicable>
Launch HScribe application and Login
HScribe will require user credentials on startup. The default factory username and password is
admin (password is case sensitive).
Schedule Order <Where applicable>
The Schedule/Orders icon is only available when the modality is not linked to an external
scheduling system. Click on the icon to open a window allowing you to schedul e Holter exams
and view the existing schedule (Refer to operator’s manual for details).
Insert the USB interface cable connector into the
recorder’s input connector. A tone sounds
indicating that the HScribe has detected the
recorder. The recorder LCD will show “USB”
indicating a powered connection.
• Click on Import recording ICON
• Select recording from the recording list
• Click on Acquire recorder/card.
• Upon completion the Profile page will
appear
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CONFORMANCE TESTING
Import H12+ Compact Flash (CF) Card Recordings
Insert flashcard with data into the HScribe CF
card reader.
SECTION 5
• Click on Import recording ICON
• Select recording from the recording list
• Click on Acquire recorder/card. Upon completion the Profile page will appear
Review and Edit Recording
•Upon completion of the Holter data import and processing, or when a previou sly acq uired
recording is opened, the Profile screen is displayed.
• Press CTRL S to view Profile and ECG screen
• Verify the recorded data is present for the appropriate time period of the recordin g
• Select various strips and save to prepare a final report
Print final Report
•To open a preview of the final report, select Print Report… from the Exam pull-down
menu or use the shortcut keys Ctrl + P. A preview is generated and the first report page
is displayed.
•View each page of report for accuracy and print final report
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CONFORMANCE TESTING
Export Data <Where applicable>
SECTION 5
• Click on exam search ICON
• Export to send the exam data to the defined destination.
• Export is only available when the export feature is enabled.
• Export button is only enabled when the exam status is Signed.
• Verify exported files are in specified location as configured in File Exchange configuration
• Open and view PDF files
Import Legacy Recordings <Where applicable>
• Click on Import Legacy
are stored. Legacy recordings must be in folder named Usr on hard drive with names of
PATxx for Legacy recordings .Once selected, all recordings at that location are shown in
the Recording List.
• Click on New Patient under the Search Patient tab.The Exam Data Entry window opens
displaying the existing demographics attached to the recording.
• Click Confirm after demographic information is complete and the Recording Information
screen showing the recording and the recorder information is displayed.
• Upon completion, Click on exit and the Profile page will be displayed.
• Press CTRL S to view Profile and ECG screen
• Select various strips and save for final report. Print report.
and browse to the directory where the legacy recordings
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CONFORMANCE TESTING
HScribe 5 Test Data Record
Software Serial #: ____________________________
Software Version: ____________________________
PASS / FAIL HScribe application login
PASS / FAIL /NA Schedule order
PASS / FAIL Import data from Holter recorder
PASS / FAIL Edit and review data
PASS / FAIL / NA Print data
PASS / FAIL / NA Export data
PASS / FAIL / NA Import legacy recording
Performed by: ______________________________ Date: _____/_____/_____
SECTION 5
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System Utilities
System Utilities
The following utilities are located at the path below to assist with system configuration and service
functions as defined.
FetchAllConfig.exe (gathers all system configuration data)
ActivationTool.exe (software license information)
CFDWizard.exe (display and report configurator)
Configurator.exe
The Modality Manager Configuration Utility is stored as a unique EXE file
(Configurator.exe) that can be accessed after the installation process is completed if
any changes are needed to the Modality Configuration settings.
SECTION 6
Refer to the following information regarding the configuration settings:
Language: This setting is always available to select the desired language.
Server Address: The Server Address will read “localhost” if the local PC is hosting the Modality Manager
database. If Modality Manager is not local, this box should contain the IP Address or Computer Name of
the PC or server hosting Modality Manager.
Log Port: This setting is always available to select the port to be used for the event log
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System Utilities
service.
API Port: This setting is always available to select the port to be used for Modality
Manager service.
Logon Mode: This setting can be set to either Local or Active Directory depending on
the user preference. If Local is selected, the Modality Manager service will maintain its
own local listing of user/password pairs for logging onto the system.
If Active Directory is selected, the Modality Manager service will access the list of users from the
Windows domain.
SECTION 6
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System Utilities
SECTION 6
FetchAllConfig.exe
Copies all of the system configuration settings into the file structure displayed below to allow this
information to be sent to a Mortara Service Center. The path can be entered by the user upon executing the
utility.
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System Utilities
SECTION 6
ActivationTool.exe
This utility will display the current software license status, serial number information, and all enabled
options.
The serial number information is necessary when contacting a Mortara Service Center for technical
assistance.
The Activation Utility is also used to perform a software Removal, which MUST be performed prior to
uninstalling the Mortara software. The software Removal process will generate a Removal Code, which
will need to be sent to Mortara to provide notification that the software license has been deactivated.
Once the software Removal has been reported to Mortara, the software may be loaded on another computer
and activated through the normal activation process.
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System Utilities
CFDWizard.exe
The CFD (Custom Format and Display) Wizard can be used to change the following items:
• Logo
• Facility Name
• Facility Address
• Phone Number
• Hide Items
SECTION 6
Customization of the Scribe 5 display appearance and reports are also available. Please co ntact your
regional Mortara Service Center for assistance with this level of customization.
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System Utilities
SECTION 6
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System Backup and Restoration
SECTION 7
System Backup
The Scribe 5 system installs a batch file that will back up all of the necessary data required to restore the
system to operation in the case of a system failure. This file can be modified to direct the system to store
the backup data to an alternate non-local location or designated storage system (recommended).
Executing the system backup copies the following information into a file called CorScribeFullBackup.7z
located on the TEMP folder of the logged in user.
Backup Notes:
be logged into the operating system as a user with administrative permissions.
• Double click on Backup.bat
• A Command Prompt window will open and the backup process will begin, once the Command
Prompt window closes the backup is complete.
• SQL Database information
• Full Disclosure Data
• User Configuration Settings
This may be a hidden file based on the current system settings.
Caution
• It is recommended that the backup be performed while the system applications are not in use (not
receiving any data).
• The Backup.bat routine can be added as a scheduled process thro ugh the Task Scheduler
• If a local backup (factory default) is used It is recommended that after a backup has been
performed that the file created from the backup be removed from the system and placed in a safe
(non-local) location.
• The process is the same for a stand-alone system and a distributed system; when performing the
backup on a distributed system the process must be performed on the PC or server that is running
Modality Manager.
• The backup process can be customized by modifying the DefaultBackupSettings.bat file and
renaming the modified file to CustomBackupSettings.bat
o
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System Backup and Restoration
o Information regarding modifications to the backup file are located within the Backup.bat
file itself.
o Please contact Mortara Instrument Technical Support Gro u p if you require assistance
with modifying the backup file.
o Mortara technical support can assist with the modification of the backup file, however
Mortara will not retain a copy of the file.
• On a distributed system the backup zip file may be parked in a sub folder:
C:\Users\<User>\AppData\Local\Temp\1
This may be a hidden file based on the current system settings.
SECTION 7
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System Backup and Restoration
System Restoration (restores to point of last performed backup)
The following process should be followed to restore a Scribe 5 system.
1. Prepare/Repair PC
2. Load OS (if applicable)
3. Install Product Software
4. Place file CorScribeFullBackup.7z in the correct restore location
5. Run Restore batch file
User must
be logged into the operating system as a user with administrative permissions.
• Place the backup file into the appropriate folder:
C:\Users\<Administrator Name>\AppData\Local\Temp
On a distributed system the file may be located is a sub folder:
C:\Users\<user>\AppData\Local\Temp\1
This may be a hidden file based on the current system settings.
• Navigate to the following path to locate the Restore.bat file
• A Command Prompt window will open and the Restore process will begin
• The Restore program will ask whether or not CreateDB.BAT will need to be run before the restore
is executed. If the system database does not need to be recreated, answer NO to this question. If
the system database has been damaged, or is being recreated, answer YES to this question.
• Once the Command Prompt window closes the backup utility has completed restoring the
following content:
o SQL Database information
o Full Disclosure Data
o User Configuration Settings
• Verify that the appropriate data has been restored (system settings or system settings and exam
data) and that the exams can be accessed.
SECTION 7
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System Backup and Restoration
Notes:
Caution
• It is recommended that the restore be performed while the system applications are not in use (not
receiving any data).
• The process is the same for a stand-alone system and a distributed system; when performing a
Restore operation on a distributed system the process must be performed on the PC or server that
is running Modality Manager.
SECTION 7
40
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