CAUTION: In the United States of America, Federal Law restricts this device to sale by or on the order
of a physician.
The information in this manual only applies to the most current Quantitative Sentinel application available as of the revision date of this publication. Specifications in this manual are subject to change without notice. Contact GE Medical Systems Information Technologies for the most current information.
Information contained in this document is proprietary to GE Medical Systems Information Technolo-gies. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any
form, in whole or in part, by any means electronic, mechanical or other otherwise, including photocopying and recording, for any purpose without written permission of GE.
This manual is intended for clinical professionals. Clinical professionals are expected to know the medical procedures, practices and terminology required to monitor patients. Operation of the product
should neither circumvent nor take precedence over required patient care, nor should it impede the
human intervention of attending nurses, physicians or other medical personnel in a manner that would
have a negative impact on patient health.
All illustrations are provided as examples only. Your product features and configuration may be different than those shown. Names of persons, institutions and places and related information are fictitious;
any similarity to actual persons, entities or places is purely coincidental.
Centricity
respective owners.
AirStrip OB
®
is a trademark owned by General Electric Company. All other marks are owned by their
®
is a registered trademark of MP4 Solutions, LP.
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CE Marking Information
Compliance
The Quantitative Sentinel (QS) product bears the CE Mark
indicating its conformity with the provisions of the Council
Directive 93/42/EEC concerning medical devices and fulfills the
essential requirements of Annex I of this directive.
Exceptions
Users should be aware of known RF sources, such as radio or TV
stations and hand-held or mobile two-way radios, and consider
them when installing a medical device or system.
Be aware that adding accessories or components, or modifying the
medical device or system may degrade its EMI (electromagnetic
interference) characteristics. Consult with qualified personnel
regarding changes to the system configuration.
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ii
Contents
CE Marking Information
Compliance .......................................................................................................................... i
Exceptions ........................................................................................................................... i
Preface
Document Information ......................................................................................................... xv
Revision history ........................................................................................................... xv
Chapter contents ......................................................................................................... xvi
Referenced documentation .......................................................................................... xvii
Related documentation ................................................................................................ xvii
Typographic Conventions .................................................................................................... xviii
Messages .................................................................................................................... xviii
Single step convention ................................................................................................. xix
Type conventions ......................................................................................................... xix
Intended Use ....................................................................................................................... xix
Safety Information ............................................................................................................... xx
Potential Electrical/Mechanical/Physical Hazards ....................................................... xx
Internet and intranet considerations ............................................................................ xxii
Surveillance and monitoring concerns ......................................................................... xxii
Erroneous data entry and calculations ........................................................................ xxii
Auto-logoff and message boxes .................................................................................. xxiii
This section includes general information for this document.
What do you want to learn about?
•Document Information (page xv)
•Typographic Conventions (page xviii)
•Intended Use (page xix)
•Safety Information (page xx)
•Service Information (page xxiv)
Document Information
This section describes how this manual is organized.
What do you want to learn about?
•Revision history (page xv)
•Chapter contents (page xvi)
Revision history
•Referenced documentation (page xvii)
•Related documentation (page xvii)
The bottom of each page includes the title of the publication, the
part number, and the revision letter of the publication. Use the
revision letter to identify which version of the document you are
reading.
The revision history of this document is summarized in the
following table.
Table 1: Revision History
Software
RevisionDate
AMarch 20036.60.0Initial release.
BMarch 20056.70.0Updated for new
CJuly 20056.70.1Added the System
VersionComment
release—includes addition of index.
Failover chapter and
made minor changes.
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Chapter contents
Preface - Document Information
Table 1: Revision History
Software
RevisionDate
DOctober 20056.70.5 Updated for new
EJanuary 20066.70.5Added Citrix Support
VersionComment
release—includes addition of Anti-Virus Software Policy, Security
Patches Policy and
Database Maintenance
information. Used for
the Pilot.
appendix and updated
the Preface.
This document is organized into several chapters. These sections
are described in the Section Contents table.
Table 2: Section Contents
NameContents
Chapter 1: QS System OverviewDescribes the QS system, it’s function,
features, processes, and archeteciture. Also describes the user interface
facilities, utility programs and tools.
Chapter 2: Process Control &
Status
Chapter 3: Network ArchitectureDescribes the two types of networks
Chapter 4: Software Considerations
Chapter 5: Preventive MaintenanceDescribes the cleaning and periodic
Chapter 6: Data BackupDescribes the importance of having a
Describes QS processes and process
arguments.
necessary for communication between
QS servers and clients and the QS
Patient Monitoring System (PMS).
Describes software installation and
upgrades.
servicing of the 3rd party equipment
that hosts and supports the operation
of the QS system.
data backup application.
Chapter 7: System FailoverDescribes backup servers and the
failover process for single and cluster
servers.
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Table 2: Section Contents
NameContents
Chapter 8: Disaster RecoveryDescribes the requirements for disas-
ter recovery, as well as how to set up
the environment for disaster recovery
and then how to recover from a disaster.
Appendix A: Glossary of Network
Terms
Appendix B: Sample Network Diagrams
Appendix C: Fetal Monitor Set-UpDescribes information necessary for
Appendix D: Unity ParametersProvides parameter descriptions and
Appendix E: QS VersionsDescribes the various versions of the
Appendix F: QS & Other Documents
Referenced documentation
There are no referenced documentation in this manual.
List of terms used to describe a network.
Illustrates a collection of diagrams represents but a small number of the network configurations that are possible
in the QS.
interfacing fetal monitors with the QS.
the identity of the corresponding QS
PMS items.
QS system and the operating systems
that support them.
Lists a number of additional publications that may help you in understanding and supporting the QS system.
Related documentation
The following documents are related to this manual.
NOTE: These manuals will only be available if the software that
they document has been installed at your facility.
Quantitative Sentinel
software application that allows obstetricians to remotely view
maternal and fetal information in virtual real time. To get more
information on AirStrip OB, contact MP4 Solutions, LP. To find out
how to install or upgrade QS with AirStrip OB, contact your GE
Healthcare representative.
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interfaces with AirStrip OB, a third-party
Preface - Typographic Conventions
Typographic Conventions
The typographic styles used to ensure reader comprehension are
described in this section.
What do you want to learn about?
•Messages (page xviii)
•Single step convention (page xix)
•Type conventions (page xix)
Messages
The following are the message conventions for this manual. Instead
of an actual message, each one describes what type of information
will be within each message type.
DANGER: Indicates an imminently hazardous situation, which, if
not avoided, will result in death or serious injury. Methods to avoid
the hazard will be included.
WARNING: Indicates a potentially hazardous situation, which, if
not avoided, could result in death or serious injury. This includes
serious adverse reactions, or limitations in use. Steps that should be
taken to avoid or minimize the hazard will be included.
CAUTION: Indicates a potentially hazardous situation, which, if
not avoided, may result in minor or moderate injury. It may also be
used to alert against unsafe practices or to describe recommended
practices for the safe and effective use of the device.
NOTE: Provides additional user information about the preceding
step or information. It does not pertain to hazards.
TIP: Provides extra information about a procedure, such as a
shortcut or an alternative method to complete a task.
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Single step convention
The following example illustrates the convention for a single step.
Other conventions used within this document are shown in the Type
Convention Definitions table.
To print the example and close the dialog box, click OK.
Type conventions
There are times when a different typeface is used in this
documentation. The following table describes these typefaces and
when they are used.
Table 3: Type Convention Definitions
Preface - Intended Use
ConventionDescription
Intended Use
Sans-serif bold
type
SANS-SERIFSMALL
CAPS
Monospace typeInformation that you type on the keyboard is dis-
Monospace italics type
Italic typeInformation in italics is used when discussing a
The information in bold sans-serif type refers to a
component name on the screen. For example, click
OK refers to the OK button on the dialog box.
Keys that you press on the keyboard are displayed
in this font. For example, press ENTER refers to the
Enter key on the keyboard.
played in this font. Examples of code (software
source code) are displayed in monospace font
also.
In software source code examples, monospace
italics are used for code comments.
variable. Any font style, excluding the monospace
styles, can be italicized for this purpose.
The Quantitative Sentinel (QS) System’s is intended for automatic
patient data management. It does this by:
•Providing the user the ability to create and use electronic forms
for entering, viewing and storing patient and facility related
data (e.g. charts, forms, graphs, chalkboards, care plans, user
reference manual).
•Interfacing with other hospital information systems and medical
devices for automatic data acquisition, viewing and storage
with the electronic patient record.
•Providing visual notification of when acquired fetal monitor
heart rate values exceed the user defined limits for high and low
fetal heart rate and poor signal quality.
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Preface - Safety Information
•Providing Spectra Alerts capabilities for fetal monitoring
(surveillance).
•Providing automatic computations of physiologic indexes (e.g.
nutrition).
•Providing calculations from user defined formulas (i.e. index
calculator).
•Providing the ability to record, with the patient record, fluid
input and output information that is defined by the user.
•Providing the ability to export patient data to relational
databases for research and Quality Assurance purposes.
•Providing the ability to archive files to a secondary or tertiary
storage medium (i.e. optical disk).
•Providing the ability to print (locally or remotely) patient
records and QS database definition (e.g. item names).
•Providing the ability to review fetal monitor data (OB-Link)
remotely over the Internet.
Safety Information
Warnings, cautions, and notes that are generally applicable to the
Centricity CIS modules are summarized as follows.
•Erroneous data entry and calculations (page xxii)
•Auto-logoff and message boxes (page xxiii)
•Security considerations (page xxiv)
Potential Electrical/Mechanical/Physical Hazards
Changes or modification to this device/system not expressly
approved by GE Medical System may cause electromagnetic
compatibility (EMC) issues with this or other equipment. This
device/system is designed and tested to comply with applicable
standards and regulations regarding EMC and needs to be installed
and put into service according to the EMC information stated as
follows.
CAUTION: Use of known RF sources, such as cell/portable
phones, or other radio frequency (RF) emitting equipment near the
system may cause unexpected or adverse operation of this device/
system. Consult qualified personnel regarding device/system configuration.
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Preface - Safety Information
CAUTION: The device/system should not be used adjacent to, or
stacked with, other equipment. If adjacent or stacked use is necessary, the device/system should be tested to verify normal operation
in the configuration in which it is being used. Consult qualified personnel regarding device/system configuration.
CAUTION: The use of accessories, transducers and cables other
than those specified may result in increased emissions or decreased
immunity performance (a test standard to confirm that industrial
equipment meets power quality and voltage sag ride-through
requirements) of the device/system.
WARNING: ELECTRICAL SHOCK HAZARD—Do not operate
equipment when moisture or liquids are present on any equipment
surface.
WARNING: FIRE HAZARD—Do not operate electrical/electronic devices such as computer workstations, power supplies, and
so forth within enclosed spaces. Sufficient ventilation must be
maintained if these devices are to operate properly, realize their
advertised service lives, and not overheat or catch fire.
WARNING: FIRE HAZARD—Adequate cooling of electrical/
electronic devices such as computer workstations, power supplies,
and so forth require unrestricted air flow to operate properly, realize
their advertised service lives, and not overheat or catch fire. Cooling vents and fan openings should be periodically inspected for
signs of debris buildup (lint, dust, and so forth) and cleaned/vacuumed whenever buildup is observed.
DANGER: EXPLOSIVE HAZARD—Do not operate equipment
in the presence of flammable anesthetics or inside an oxygenated
environment. The potential for fire or explosion could leave users
with no warning and time to escape.
WARNING: INFECTION HAZARD—Do not omit QS equipment
from established cleaning and disinfecting procedures appropriate
for the environments at your facility. Failure to do so could expose
patients and staff members to unnecessary risk of infection.
CAUTION: CONDENSATION HAZARD—Do not operate
equipment recently subjected to environmental variations in temperature and humidity. The potential for accumulation of internal
condensation could result in equipment damage.
CAUTION: Disposal HAZARD—Do not dispose of equipment in
unsorted municipal waste.
This symbol indicates that the waste of electrical and
electronic equipment must be collected separately. Please contact
an authorized representative of the manufacturer for information
concerning the decommissioning of your equipment.
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Internet and intranet considerations
WARNING: Data Accuracy—Users should always verify clinical
data retrieved from (provided by) Internet or intranet sites accessed
via the GE Medical Systems Information Technologies QS URL
capability. The content or operation of the various displays (for
example, pages) is the responsibility of the authors of the individual
Internet or intranet sites.
WARNING: GE Medical Systems Information Technologies nei-
ther guarantees nor assumes any responsibility for the content of
the displays provided by individual sites or the accuracy of the
information that they provide.
Surveillance and monitoring concerns
CAUTION: DATA INTERPRETATION—Users should be aware
of the operational characteristics of QS Fetal Surveillance Alerts
(Hi/Lo Notifications & Spectra). Users should familiarize themselves with the audio/visual indications associated with the alerts
feature employed at their site prior to use—refer to the FHR Notifi-cations Guidelines or Spectra Alerts - Overview information
sheets. Failure to review this material could result in misinterpretation of fetal (maternal) conditions.
CAUTION: MONITOR DIFFERENCES—Users should be aware
of fetal monitor characteristics as they are interpreted for display by
the QS system. In general, thick lines on the paper strip correspond
to ‘red’ lines on the QS strip; while, thin lines on the paper strip
correspond to ‘black’ lines on the QS strip. Users at institutions
using fetal monitors from different manufacturers should be aware
of this QS operational characteristic.
NOTE: TIME SYNCHRONIZATION—Users and members of the
Biomedical Engineering staff should be aware that the time on the
monitor must be synchronized with the time on the QS. Time
synchronization between all devices and QS workstations (servers
and clients) is critical. Anomalies will result if synchronization is
not maintained. The user may see anomalies such as:
•Charting irregularities with the recorded time of clinical data
entry (modify time).
•Fetal strips that restart when workstation displays are refreshed.
•PDATS (QS patient data server) exhibits storage errors.
•Monitored data is not stored when special procedures (noninvasive blood pressure and cardiac output) are performed.
Erroneous data entry and calculations
NOTE: Data Computation—The Centricity CIS modules may
compute data values based upon data entered by the clinical
practitioner and the formulas provided by the System
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Preface - Safety Information
Administrator. Failure to ensure (1) accurate data entry and (2)
correct formula definition could result in the generation of
inaccurate computations.
NOTE: Data Entry—Be sure that the desired patient is selected
before performing data entry. Failure to make the desired patient
the focal point of data operations could result in the data being
placed into another patient file.
NOTE: Drug Computations—Clinical users must ensure that
correct data values are entered for the QS Compute function.
Failure to comply with this requirement could result in an incorrect
recommendation of drug rate or dose.
NOTE: File Merging—Although the patient merge mechanism is a
relatively simple process, the clinical user must pay close attention
to (1) patient selection and (2) data sources for each of the indicated
data items. Failure to comply with this direction could result in an
output file containing data from inappropriate sources (patients).
NOTE: Multiple Patients—Clinical users should be aware that
multiple patients can be assigned to the same bed if a patient
location dialog box (used for admission, discharge, and transfer
functions) is open, and another user or process (such as an ADT
interface) makes an assignment to the same bed prior to that dialog
box being closed. Failure to observe/correct this situation result in
data being placed into the wrong patient file. For this reason, you
should verify patient location (via the QS roster display) after a
transfer, admission, or discharge. If multiple patients are listed for a
bed, you should either relocate the incorrectly placed patient or
merge the patient files if the situation resulted from a single patient
having been assigned an erroneous ID.
NOTE: Patient Identification—Be sure that the patient who
previously occupied a specific bed has been discharged (placed in a
unit Hold bed) before recording/monitoring data on the next patient
placed in that bed. Failure to conform to this requirement could
result in data being placed into the wrong patient file.
NOTE: Typographical Errors—Although the Centricity CIS
modules may be configured to ensure that numeric data (for
example, pulse, BP, or temperature) is within a specified range of
acceptability, users may make typographical errors when entering
data. Failure to verify your manually entered data could result in the
storage of incorrect data.
Auto-logoff and message boxes
WARNING: If a message is displayed when the system auto-logs
off, when a user next logs in (regardless of whether it is the same or
a different user), the message will still be displayed. However,
when the message box is dismissed by the user a grey screen is displayed and the user must exit the system to continue.
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Security considerations
NOTE: System Security—The Centricity CIS system provides the
capability to define the degree of user access to workstations
through the use of IDs and passwords. It also allows the assignment
of READ/WRITE privileges via security objects to determine who
may access or record patient data. Failure to properly configure the
security feature could result in unauthorized personnel gaining
entry into Centricity and ultimately viewing or recording patient
data.
Service Information
If you need help with the Centricity CIS modules or want to speak
with customer support, call the applicable number from the
following table, and one of our representatives will assist you.
Table 4: Customer Support Phone Numbers
AreaPhone Number
Preface - Service Information
Within US1-800-433-2009
Outside US+49 761 4543-600
Introduction to the Quantitative Sentinel (QS) System
The QS Clinical Information System (CIS) is designed to automate
record keeping in medical facilities such as intensive care units
(ICUs), operating rooms (ORs), obstetrical/gynecological (OB/
GYN) units, and units operating on the general floor. The QS
Designer enables individual medical organizations to easily
configure their systems to meet specific data management
requirements without the assistance of experienced medical
programmers. Use of the QS Designer should be limited to the
institution’s assigned System Manager(s).
User Interface
The Microsoft’s Windows® operating system provides the user
interface for the QS system. This interface allows the use of
function keys, icons, and menus to facilitate user direction of
system operations. Scrollable windows provide access to the
various screen displays and user dialog boxes necessary for data
entry, storage, and retrieval. User interaction with the QS system
may be accomplished through a variety of devices such as
keyboards, mouse devices, and trackballs.
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Interface Customization
System Managers may customize the operation of the QS system to
meet the specialized needs of different clinical users. This is
accomplished through the definition of Views that exhibit unique
display formats, specialized collections of charts and forms, and so
on. View definition also allows the System Manager to provide
specific forms of navigation (toolbars, menus, tab control
navigators, and function keys) through the QS system that are
specifically tailored to meet the needs of individual user groups.
Users who have a wide range of responsibilities may be assigned
multiple views; this will allow selection of the view best suited for
the clinical environment in which they are functioning at any point
in time. Views may be defined for environments such as operating
rooms, intensive care units, labor and delivery units, neonatal
intensive care units, and so on. As user experience and expertise
grow, you should solicit their inputs about special clinical needs
(new or modified charts, forms, function key assignments, and so
forth) so that you may better refine the operational capabilities of
currently defined view(s) and create new ones as the need presents
itself.
Preface - User Background
Supported Interfaces
User Background
Disclaimers
The QS system employs Microsoft- and IBM-supported software
architectural standards, an IBM-compatible microcomputer
platform, and standard off-the-shelf network hardware and software
products. Adherence to industry standards allows the QS system to
easily connect to and acquire data from existing hospital
information systems (HIS) and laboratory information systems
(LIS).
The intended users of this manual are facility staff members who
have been tasked with maintaining the operation of the QS system.
This manual should be mandatory reading for all QS System
Managers, placed in a convenient location to facilitate its use as a
reference, and employed as orientation material for prospective QS
System Managers.
The following disclaimers clarify the intent of this manual’s content
and the manner of its presentation. These statements address system
operational considerations, design changes, reproduction rights,
and the use of patient data as defined in the paragraphs that follow.
What would you like to learn about?
Customer Responsibility for Medical Record (page xxvi)
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Preface - Disclaimers
Data Collection (page xxvi)
Design Changes (page xxvi)
Patient Care (page xxvi)
References to Persons, Places, and Institutions (page xxvi)
Reproduction Rights (page xxvii)
Customer Responsibility for Medical Record
Customers are responsible for determining the form, type, and
presentation of the data and documentation that will constitute the
official patient medical record. The QS system enables customers
to configure the type of data captured and the electronic and printed
displays of data. It is the customers’ responsibility to become
familiar with the features of the system in order to make informed
decisions about the data, processes, media, and formats that they
may choose to capture, extract, archive, and display for the
purposes of an official medical record.
Data Collection
The QS system is not intended to replace the patient information
obtained from patient monitoring equipment with which it is
interfaced; rather, it should be employed as a supplemental device
that allows the clinical staff to enter, store, retrieve, and view data
in a more efficient yet flexible manner.
Design Changes
Due to design changes associated with continuing product
improvements, information in this manual is subject to change. GE
reserves the right to change software design at any time and any
such changes could affect the contents of this manual. GE assumes
no responsibility for any errors or inconsistencies appearing in this
manual that result from product design changes and upgrades.
Patient Care
Operation of the QS should neither circumvent nor take precedence
over required patient care, nor should it impede the human
intervention of attending nurses, physicians, or other medical
personnel in a manner that would have a negative impact on patient
health.
References to Persons, Places, and Institutions
References to persons, places, and institutions used within this
manual are solely intended to facilitate user comprehension of the
QS system’s use and functions. Extreme care has been taken to use
fictitious names and related information in the examples and
illustrations provided herein. Any similarity of this data to persons
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