ServiceManual
AClinicalInformationSystem
QUANTITATIVESENTINEL
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®
QuantitativeSentinel®ServiceManual
GEMedicalSystemsInformationTechnologies
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physician.
FirstPrinting:March2003
QuantitativeSentinelandQSareregisteredtrademarks.Allotherproductandbrandnamesaretrademarksorregistered
trademarksoftheirrespectivecompanies.
©2003 General Electric Company. All rights reserved.
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CEMarkingInformation
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 twoway 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.
REVISIONHISTORY
The following table summarizes this manual’s revision history by providing the revision label, effective
date, QS software version and comments appropriate for each release.
Table of Revision History
Revision Date QSVersion Comments
AMarch2003 6.60.0 InitialRelease
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CE MARKING INFORMATION
COMPLIANCE ..................................................................................................................................... A
EXCEPTIONS ...................................................................................................................................... A
REVISION HISTORY .......................................................................................................................... A
PREFACE
INTRODUCTION TO THE QUANTITATIVE SENTINEL (QS) ....................................................xiii
User Interface ...............................................................................................................................xiii
Interface Customization ................................................................................................................xiii
Supported Interfaces .....................................................................................................................xiii
USER BACKGROUND .....................................................................................................................xiii
DISCLAIMERS ..................................................................................................................................xiv
Data Collection .............................................................................................................................xiv
Design Changes ............................................................................................................................ xiv
Patient Care ...................................................................................................................................xiv
References to Persons, Places, and Institutions ............................................................................xiv
Reproduction Rights .....................................................................................................................xiv
SAFETY SUMMARY
WARNINGS, CAUTIONS, AND NOTES ......................................................................................... xv
General Definitions ........................................................................................................................ xv
QS Safety Summary .....................................................................................................................xvi
Potential Electrical/Mechanical/Physical Hazards .................................................................xvi
Internet/Intranet Considerations ............................................................................................xvii
Surveillance/Monitoring Concerns .......................................................................................xvii
Erroneous Data Entry/Calculations ......................................................................................xviii
Security Considerations .........................................................................................................xix
CHAPTER1
QS SYSTEM OVERVIEW
QS DESCRIPTION ................................................................................................................................1
Capabilities ......................................................................................................................................1
Intended Users of the QS .................................................................................................................1
User Environment ............................................................................................................................2
Patient Applicability ........................................................................................................................ 2
HIPAA Conformance ......................................................................................................................2
QS Features ............................................................................................................................................ 2
Manual Patient Data Recording ....................................................................................................... 2
Charts ........................................................................................................................................ 2
Forms ........................................................................................................................................3
Chalkboard ................................................................................................................................3
MAR (Medication Administration Record) .............................................................................. 3
Automated Patient Data Recording ................................................................................................. 3
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Hospital Information Systems (HISs) ....................................................................................... 3
Devices ......................................................................................................................................3
Fetal Heart Rate (FHR) Notifications .............................................................................................. 4
Printing and Faxing ......................................................................................................................... 4
Index Calculator .............................................................................................................................. 4
Compute ...........................................................................................................................................4
On-line Help .................................................................................................................................... 4
Security ............................................................................................................................................4
Export ..............................................................................................................................................4
Archive ............................................................................................................................................4
QS Architecture ...................................................................................................................................... 5
User Interface Facilities .........................................................................................................................8
QS Processes .......................................................................................................................................... 9
Archive ............................................................................................................................................9
BRelay .............................................................................................................................................9
CDATS .......................................................................................................................................... 10
CDSS ............................................................................................................................................. 10
HIS .................................................................................................................................................11
LAS ................................................................................................................................................ 11
LOGS ............................................................................................................................................. 12
PDATS ........................................................................................................................................... 12
PDSS .............................................................................................................................................. 13
PFILS .............................................................................................................................................13
PMS ............................................................................................................................................... 14
PtD .................................................................................................................................................14
QPM ............................................................................................................................................... 15
SPP ................................................................................................................................................. 15
System Functions .................................................................................................................................15
Log files .........................................................................................................................................15
Storage Configuration ....................................................................................................................16
Single Server Systems - Windows NT ....................................................................................16
Single Server Systems - Windows 2000 .................................................................................17
Dual Server Systems (Windows NT Only) ............................................................................. 18
File Naming Convention .........................................................................................................19
QS Directory Structure ............................................................................................................20
D:\QS\Archive.................................................................................................................. 20
D:\QS\Archive\Image....................................................................................................... 20
D:\QS\Data ....................................................................................................................... 20
D:\QS\Exe......................................................................................................................... 20
D:\QS\HL7Out ................................................................................................................. 20
D:\QS\Logs....................................................................................................................... 20
D:\QS\MSAccess.............................................................................................................. 20
D:\QS\Pfils ....................................................................................................................... 20
D:\QS\Release\NT............................................................................................................ 20
D:\QS\Site......................................................................................................................... 20
D:\QS\SPP ........................................................................................................................ 21
D:\QS\Tools...................................................................................................................... 21
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D:\QS\Web ....................................................................................................................... 21
Archive and Restore ...................................................................................................................... 21
The archiving process ............................................................................................................. 21
The archive database ............................................................................................................... 22
Patient file size considerations ................................................................................................ 22
How Archive initializes disks .................................................................................................23
What happens when one of the CD-R drives is not operational .............................................23
CD-R life expectancy ..............................................................................................................23
Other important things to know about Archive ......................................................................23
Files used by Archive .............................................................................................................. 24
In the staging area:............................................................................................................ 24
In the image directory:...................................................................................................... 24
Archive Admin Commands .................................................................................................... 25
QPM Restore ........................................................................................................................... 25
Problems restoring due to CD drive dirty / CD-R media problems ........................................ 26
Printing ..........................................................................................................................................27
Batch printing ......................................................................................................................... 27
Scheduled printing .................................................................................................................. 27
OB Link .........................................................................................................................................28
QSWeb .................................................................................................................................... 29
Internet Information Server (IIS from Microsoft) ................................................................... 30
Log files ..................................................................................................................................30
Strings Files .............................................................................................................................30
OB Link web files ................................................................................................................... 31
Strip chart applet and screen size applet ................................................................................. 31
Browser setup .......................................................................................................................... 32
Certificate installation ...................................................................................................... 32
Internet Explorer 4.01....................................................................................................... 32
Internet Explorer 5.0 and higher....................................................................................... 32
Netscape 4.5 and higher ................................................................................................... 32
Server Startup Process ...................................................................................................................33
Client Startup Process .................................................................................................................... 34
UTILITY PROGRAMS .......................................................................................................................35
CDATDisp ..................................................................................................................................... 35
CDUpdate ...................................................................................................................................... 35
Designer .........................................................................................................................................35
QSCopy ......................................................................................................................................... 36
QSTest ...........................................................................................................................................36
QS TOOLS - VERSION 6.60.0 ........................................................................................................... 36
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CHAPTER2
PROCESS CONTROL & STATUS
INTRODUCTION ................................................................................................................................ 43
QS PROCESSES .................................................................................................................................. 44
PROCESS ARGUMENTS ................................................................................................................... 45
Archive Arguments ........................................................................................................................ 45
SET .......................................................................................................................................... 45
SHOW ..................................................................................................................................... 45
BRelay Arguments ........................................................................................................................46
SET .......................................................................................................................................... 46
SHOW ..................................................................................................................................... 46
CDATS Arguments ....................................................................................................................... 47
SET .......................................................................................................................................... 47
SHOW ..................................................................................................................................... 47
CDSS Arguments ..........................................................................................................................47
SET .......................................................................................................................................... 47
SHOW ..................................................................................................................................... 47
HIS-HL7 (Inbound) Arguments ....................................................................................................48
SET .......................................................................................................................................... 48
HIS-HL7O (Outbound) Arguments ............................................................................................... 48
SHOW ..................................................................................................................................... 48
SET .......................................................................................................................................... 48
LAS Arguments ............................................................................................................................. 49
SET .......................................................................................................................................... 49
SHOW ..................................................................................................................................... 49
LOGS Arguments .......................................................................................................................... 49
SET .......................................................................................................................................... 49
SHOW ..................................................................................................................................... 49
PDATS Arguments ........................................................................................................................ 49
SET .......................................................................................................................................... 49
SHOW ..................................................................................................................................... 49
PDSS Arguments ........................................................................................................................... 50
SET .......................................................................................................................................... 50
SHOW ..................................................................................................................................... 50
PFILS Arguments .......................................................................................................................... 51
SET .......................................................................................................................................... 51
SHOW ..................................................................................................................................... 51
PMS Arguments ............................................................................................................................52
SET .......................................................................................................................................... 52
System Modes .................................................................................................................. 52
Per Acquire....................................................................................................................... 52
Per Bed ............................................................................................................................. 53
Beds with Serial Fetal Monitor Acquire........................................................................... 53
Per Bed/Acquire ............................................................................................................... 53
SHOW ..................................................................................................................................... 53
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PtD Arguments .............................................................................................................................. 54
SET .......................................................................................................................................... 54
QPM Arguments ............................................................................................................................54
CYCLE .................................................................................................................................... 54
SET .......................................................................................................................................... 54
SHOW ..................................................................................................................................... 54
QSConnect Arguments .................................................................................................................. 55
SHOW ..................................................................................................................................... 55
SET .......................................................................................................................................... 55
SPP Arguments ..............................................................................................................................55
SHOW ..................................................................................................................................... 55
SET .......................................................................................................................................... 55
CHAPTER3
NETWORK ARCHITECTURE
OVERVIEW ........................................................................................................................................ 57
FETAL MONITOR COMMUNICATION: DIGI & EQUINOX ........................................................ 57
SERIAL COMMUNICATION: DIGI EQUIPMENT .........................................................................58
Cable Specifications ...................................................................................................................... 59
Copper room-to-concentrator .................................................................................................. 59
Copper concentrator-to-concentrator/concentrator-to-host adapter card ................................ 59
Fiber optic concentrator-to-concentrator/concentrator-to-host adapter card ..........................59
SERIAL COMMUNICATION: EQUINOX EQUIPMENT ............................................................... 59
IP COMMUNICATION: LAN ............................................................................................................60
Cable Specifications ...................................................................................................................... 61
IP COMMUNICATION: WAN ISSUES ............................................................................................ 62
IP COMMUNICATION: NETWORK TRAFFIC ............................................................................... 62
DIALUP ACCESS TO THE QS .......................................................................................................... 63
THE QS AND THE HOSPITAL NETWORK ENVIRONMENT ...................................................... 63
INTERFACES ...................................................................................................................................... 63
UNITY ISSUES ...................................................................................................................................64
NT ISSUES .......................................................................................................................................... 64
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CHAPTER4
SOFTWARE CONSIDERATIONS
OVERVIEW ........................................................................................................................................ 67
SOFTWARE INSTALLATION ..........................................................................................................67
Prerequisites ................................................................................................................................... 68
Assumptions ..................................................................................................................................70
Installation Procedure .................................................................................................................... 71
SOFTWARE (VERSION) UPGRADES ............................................................................................. 73
Upgrade Process ............................................................................................................................73
Release Notes .......................................................................................................................... 73
Additional costs ....................................................................................................................... 73
Installation ...............................................................................................................................73
Personnel requirements .................................................................................................... 73
System down-time............................................................................................................ 73
Upgrading sites not under warranty (without a valid SSA) .................................................... 74
Upgrading sites under warranty (with a valid SSA) ............................................................... 74
Upgrade Preparation Checklist ...................................................................................................... 75
CHAPTER5
PREVENTIVE MAINTENANCE
OVERVIEW ........................................................................................................................................ 79
GE RECOMMENDATIONS ............................................................................................................... 79
CHAPTER6
DATA BACKUP
SOURCE OF BACKUP TOOLS .........................................................................................................81
RESPONSIBILITY .............................................................................................................................. 81
IMPORTANT CONSIDERATIONS ................................................................................................... 81
AppendixA
GLOSSARY - NETWORK TERMS
AppendixB
SAMPLE NETWORK DIAGRAMS
Overview ............................................................................................................................................B-1
List of Diagrams ................................................................................................................................. B-1
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AppendixC
FETAL MONITOR SET-UP
List of Fetal Monitors .........................................................................................................................C-1
Corometrics® 115 .......................................................................................................................C-2
Corometrics® 116 .......................................................................................................................C-4
Corometrics® 118 .......................................................................................................................C-5
Corometrics® 120 Series ............................................................................................................. C-6
Corometrics® 145 .......................................................................................................................C-6
Corometrics® 150 .......................................................................................................................C-6
Corometrics® 151 .......................................................................................................................C-7
Corometrics® 170 Series ............................................................................................................. C-8
Agilent / Hewlett Packard Series 50 (1350, 1351, 1353) ............................................................ C-9
Hewlett Packard 8040 ................................................................................................................ C-10
AppendixD
UNITY PARAMETERS
List of Supported Devices ..................................................................................................................D-1
Allied Health Care Bear 1000 .....................................................................................................D-2
Baxter Vigilance ..........................................................................................................................D-3
Bird VIP .......................................................................................................................................D-4
Datex Capnomac ..........................................................................................................................D-5
Dräger Babylog 8000 ...................................................................................................................D-6
Dräger Cato ..................................................................................................................................D-7
Dräger Evita .................................................................................................................................D-8
Dräger Evita 2 ............................................................................................................................D-10
Dräger Evita 2 Dura ...................................................................................................................D-12
Dräger Evita 4 ............................................................................................................................D-14
Dräger Julian ..............................................................................................................................D-16
Dräger PM8060 .........................................................................................................................D-17
Engstrom Elsa ............................................................................................................................D-18
Hamilton Veolar ........................................................................................................................D-19
Hellige SMU EVO .....................................................................................................................D-20
Nellcor Puritan Bennet Adult Star 950 / 1500 / 2000 ................................................................D-22
Nellcor Puritan Bennet Infant Star ............................................................................................D-23
Nellcor Puritan Bennet Infant Star 500 .....................................................................................D-23
Nellcor Puritan Bennet Infant Star 950 .....................................................................................D-24
Nellcor Puritan Bennet pb7200 .................................................................................................D-25
Sechrist 600APM .......................................................................................................................D-26
Siemens SC 9000 .......................................................................................................................D-27
Servo 300 ...................................................................................................................................D-28
Siemens Servo 900 ....................................................................................................................D-29
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AppendixE
QS & OTHER DOCUMENTS
QS DOCUMENTATION ................................................................................................................... E-1
WINDOWS NT & WINDOWS 2000 ................................................................................................ E-1
NETWORKING ................................................................................................................................. E-1
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ListofFigures
FigureTitle PageNumber
QS Context Diagram.................................................................................................................. 5
Major Patient Data Interactions within the QS ..........................................................................6
Ancillary QS Processes.............................................................................................................. 7
Single Server Disk Configuration - Windows NT ...................................................................16
Single Server Disk Configuration - Windows 2000.................................................................17
Dual Server - Disk Configuration ............................................................................................18
Archive Data Flow ...................................................................................................................21
Printer Configuration for Batch and Scheduled Printing .........................................................27
OB Link Fetal Strip Display ....................................................................................................29
QS Server Startup Process .......................................................................................................33
QS Client Startup Process ........................................................................................................34
Network Commands Dialog.....................................................................................................43
Digi Serial Connections ........................................................................................................... 58
Hubs Versus Switches ..............................................................................................................60
HL7 Solar Lab Access Configuration.................................................................................... B-2
Intensive Care Configuration - Single Unit ...........................................................................B-3
Intensive Care Configuration - Multiple Units ...................................................................... B-4
Surveillance Configuration - Single Unit...............................................................................B-5
Surveillance Configuration with Equinox Concentrator - Multiple Units............................. B-6
Surveillance Configuration - Wide Area Network (WAN) ....................................................B-7
Surveillance Configuration (WAN) - Primary & Remote Sites............................................. B-8
Surveillance Configuration WAN-Ring .................................................................................B-9
Corometrics® 116 Set-up.......................................................................................................C-4
Corometrics® 118 Set-up.......................................................................................................C-5
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ListofTables
TableTile PageNumber
Table of Revision History ............................................................................................A
Drive Letter Assignments - Windows NT ..................................................................17
Drive Letter Assignments - Windows 2000 ...............................................................18
QS Component File Name Examples .........................................................................19
Content of T6600l14.EXE ..........................................................................................36
Network Commands Dialog - Component Descriptions ............................................44
Client Workstation Requirements ...............................................................................68
Server Workstation Requirements ..............................................................................69
Network Requirements ...............................................................................................70
Tools Version Applicability ........................................................................................70
Installation Command Parameters ..............................................................................71
Example Upgrade Preparation Checklist ....................................................................75
Corometrics 115 Dip Switch Settings - Switch SW1 ...............................................C-2
Corometrics 115 Dip Switch Settings - Switch SW2 ...............................................C-2
Corometrics 115 Dip Switch Settings - Switch SW3 ...............................................C-3
Corometrics® 151 RS-232 Port Configuration Settings ..........................................C-7
Corometrics® 170 Series Service Codes ..................................................................C-9
Parametric Data - Allied Health Care Bear 1000 ..................................................... D-2
Parametric Data - Baxter Vigilance ......................................................................... D-3
Parametric Data - Bird VIP ...................................................................................... D-4
Parametric Data - Datex Capnomac ......................................................................... D-5
Parametric Data - Dräger Babylog 8000 .................................................................. D-6
Parametric Data - Dräger Cato ................................................................................. D-7
Parametric Data - Dräger Evita ................................................................................ D-8
Parametric Data - Dräger Evita 2 ........................................................................... D-10
Parametric Data - Dräger Evita 2 Dura .................................................................. D-12
Parametric Data - Dräger Evita 4 ........................................................................... D-14
Parametric Data - Dräger Julian ............................................................................. D-16
Parametric Data - Dräger PM8060 ........................................................................ D-17
Parametric Data - Engstrom Elsa ........................................................................... D-18
Parametric Data - Hamilton Veolar ....................................................................... D-19
Parametric Data - Hellige SMU EVO .................................................................... D-20
Parametric Data - Nellcor Puritan Bennet Adult Star 950 / 1500 / 2000 ............... D-22
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TableTile PageNumber
Parametric Data - Nellcor Puritan Bennet Infant Star ........................................... D-23
Parametric Data - Nellcor Puritan Bennet Infant Star 500 .................................... D-23
Parametric Data - Nellcor Puritan Bennet Infant Star 950 .................................... D-24
Parametric Data - Nellcor Puritan Bennet pb7200 ................................................ D-25
Parametric Data - Sechrist 600APM ...................................................................... D-26
Parametric Data - Siemens SC 9000 ...................................................................... D-27
Parametric Data - Servo 300 .................................................................................. D-28
Parametric Data - Siemens Servo 900 ................................................................... D-29
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PREFACE
INTRODUCTIONTOTHEQUANTITATIVESENTINEL(QS)
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).
UserInterface
Microsoft’s Windows® operating system provides the user interface for the QS. 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 dialogs necessary for data entry,
storage, and retrieval. User interaction with the QS may be accomplished through a variety of devices
such as keyboards, mice, and trackballs.
InterfaceCustomization
System Managers may customize the operation of the QS 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, etc. View definition also allows the System
Manager to provide specific forms of navigation (toolbars, menus, tab control navigators, and
functions keys) through the QS 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 operatingrooms, intensivecareunits,
laboranddeliveryunits, neonatalintensivecareunits, etc. As user experience and expertise grow, you
should solicit their inputs about special clinical needs (new or modified charts, forms, function key
assignments, etc.) so that you may better refine the operational capabilities of currently defined
view(s) and create new ones as the need presents itself.
SupportedInterfaces
The QS 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 to easily connect to and acquire data from existing
hospital information systems (HIS) and laboratory information systems (LIS).
USERBACKGROUND
The intended users of this manual are facility staff members who have been tasked with maintaining the
operation of the QS.
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Preface-DISCLAIMERS
DISCLAIMERS
Disclaimers have been stated below to 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.
DataCollection
The QS 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.
DesignChanges
Due to design changes associated with continuing product improvements, information in this manual is
subject to change. GE Medical Systems InformationTechnologies(hereafter referred to as 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.
PatientCare
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.
ReferencestoPersons,Places,andInstitutions
References to persons, places, and institutions used within this manual are solely intended to facilitate
user comprehension of the QS’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 either living or dead and to either current or previously existing medical institutions should be
regarded as coincidental.
ReproductionRights
No part of this manual may be reproduced, stored in a retrieval system, or transmitted in any form
or by any means - electronic, mechanical, photographic, etc. - without the prior written permission of
GE. All inquiries regarding this manual and/or the Quantitative Sentinel System should be directed to
GE.
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SAFETYSUMMARY-WARNINGS,CAUTIONS,ANDNOTES
SAFETYSUMMARY
WARNINGS,CAUTIONS,ANDNOTES
Warnings, cautions, and notesappear throughout this manual as preventive instructions designed to (1)
ensure the safety of individuals using or in close proximity to the QS, and (2) safeguard the integrity and
condition of the equipment and software employed by the system. These preventive instructions are
presented and defined below. This manual should be (1) mandatory reading for all QS System Managers,
(2) placed in a convenient location to facilitate its use as a reference, and (3) employed as orientation
material for prospective QS System Managers. This section of the manual also summarizes documentation
symbols found within this manual.
GeneralDefinitions
The significance of warnings, cautionsand notesis generically discussed below. Considerations that
generally apply throughout this manual are summarized in a subsequent paragraph.
WARNINGS ...............provide the user with instructions intended to prevent the occurrence of
mishaps that could result in either injury or loss of life. Warni n g s will
always precede the instructions that possess the potential for human
injury.
CAUTIONS ................ provide the user with instructions intended to prevent the occurrence of
mishaps that could result in damage to system equipment/software. Cau-
tionswill always precede the instructions that possess the potential for
equipment damage.
NOTES ........................ provide the user with instructions intended to prevent inappropriate
actions that will result in neither human injury nor equipment damage.
The cost associated with failure to observe a procedural note will typically be in wasted time and effort. Noteswill always precede the instructions that possess the potential for procedural error.
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SAFETYSUMMARY-WARNINGS,CAUTIONS,ANDNOTES
QSSafetySummary
Warnings and cautions that are generally applicable to the various configurations of the QS, as
exemplified in this manual, are summarized as follows:
PotentialElectrical/Mechanical/PhysicalHazards
WARNINGS
CONDUCTIVE HAZARD – Do not use adapters or make plug
modifications to equipment power cords.
ELECTRICAL SHOCK HAZARD – Do not operate equipment when
moisture or liquids are present on any equipment surface.
FIRE HAZARD – Do not operate electrical/electronic devices such as
computer workstations, power supplies, etc. 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.
FIRE HAZARD – Adequate cooling of electrical/electronic devices such
as computer workstations, power supplies, etc. 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, etc.) and
cleaned/vacuumed whenever buildup is observed.
EXPLOSIVE HAZARD – Do not operate equipment in the presence of
flammable anesthetics or inside an oxygenated environment.
INFECTION HAZARD – Do not omit QS equipment from established
cleaning/disinfecting procedures appropriate for the environments at your
facility. Failure to do so could expose patients, staff members, etc. to
unnecessary risk of infection.
PHYSICAL HAZARD – Do not modify physical placement/connection
of QS equipment. Improper stowage could result in physical instability
and possible injury to user/patient.
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.
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SAFETYSUMMARY-WARNINGS,CAUTIONS,ANDNOTES
Internet/IntranetConsiderations
WARNING
DATA ACCURACY – Users should always verify clinical data retrieved
from (provided by) internet/intranet sites accessed via the QS URL
capability. The content/operation of the various displays (e.g. pages) is the
responsibility of the authors/owners of the individual internet/intranet
sites.
GE neither 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/MonitoringConcerns
CAUTIONS
DATA INTERPRETATION – Users should be aware of the operational
characteristics of QSFetalSurveillanceAlerts (Hi/LoNotifications &
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 FHRNotificationsGuidelines or SpectraAlerts-
Overview information sheets contained within this manual. Failure to
review this material could result in misinterpretation of fetal (maternal)
conditions.
MONITOR DIFFERENCES – Users should be aware of fetal monitor
characteristics as they are interpreted for display by the QS. In general,
thicklinesonthepaperstrip correspond to ‘red’ lines on the QS strip;
while, thinlinesonthepaperstripcorrespond to ‘black’ lines on the QS
strip. Users at institutions using fetal monitors from different
manufacturers should be aware of this QS operational characteristic.
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 (non-invasive
bloodpressure and cardiacoutput) are performed.
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ErroneousDataEntry/Calculations
NOTES
DATA COMPUTATION – The QS may compute data values based upon
data entered by the clinical practitioner and the formula provided by the
QS System Manager. Failure to ensure (1) accurate data entry and (2)
correct formula definition could result in the generation of inaccurate
computations.
DATA ENTRY – Be sure that the desired patient is selected before
performing data entry via charts, chalkboards, etc. Failure to make the
desired patient the focal point of data operations could result in the data
being placed into another patient file.
DRUG COMPUTATIONS – Clinical users should 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/dose.
FILE MERGING – Although the QS patient merge mechanism is a
relatively simple process, the clinical user should 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).
MULTIPLE PATIENTS – Clinical users should be aware that multiple
patients can be assigned to the same bed if (1) a patient location dialog
box (used for admission, discharge, and transfer functions) is open, and
(2) 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 (1) relocate the incorrectly placed
patient or (2) merge the patient files if the situation resulted from a single
patient having been assigned an erroneous ID.
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.
TYPOGRAPHICAL ERRORS – Although the QS may be configured to
ensure that numeric data (pulse, BP, temperature, etc.) 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.
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SecurityConsiderations
SYSTEM SECURITY – The QS provides the capability to define the
degree of user access to QS workstations via the use of IDs and
passwords. It also allows the assignment of READ/WRITE privileges to
determine who may access/record patient data on a per item basis. Failure
to properly configure the QS security feature could result in unauthorized
personnel gaining entry into the QS and ultimately viewing/recording
patient data.
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Chapter1
QSSystemOverview
QSDESCRIPTION
The QS system is a software application that operates on industry standard, off-the-shelf software and
computer/network hardware. It is a form of application software commonly referred to as a clinicaldata
managementsystem or clinicalinformationsystem.The primary focus of this type of software is to provide
a data management tool that allows medical institutions to define electronic charts and forms similar to
their paper counterparts, to manually enter or automatically acquire, display, store and retrieve patient and
clinical practice information.
Capabilities
The primary or general purpose of the QS is to provide automated patient data entry. It accomplishes
this by:
1. Allowing creation and use of electronic charts and forms for entering, storing, retrieving,
and viewing patient/facility related data (e.g. charts, forms, graphs, chalkboards, user
reference manuals, medication administration records).
2. Interfacing with other hospital information systems and medical devices for select,
automatic data acquisition, viewing and storage with the electronic patient record.
3. 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.
4. Providing Spectra Alerts capabilities for fetal monitoring (surveillance).
5. Recording acquired fetal monitor data with patient record.
6. Providing automatic computations of physiological indices.
7. Providing calculations from user defined formulas.
8. Providing the ability to record, with the patient record, fluid input and output information
that is defined by the user.
9. Providing the ability to export patient data to a relational database for research, reporting
and quality assurance purposes.
10. Providing the ability to archive files to a secondary or a tertiary storage medium.
11. Providing the ability to print.
IntendedUsersoftheQS
Intended users nurses, nurse managers, physicians as well as other licensed care providers and trained/
site authorized personnel with system configuration and maintenance responsibilities
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UserEnvironment
The QS is intended for use in a hospital or other clinical setting.
PatientApplicability
Access to the patient population is restricted to only those patients within units configured for use with
the QS.
Users should note that:
• The QS is not connected directly to any patient;
• The QS is not intended to replace the patient information obtained from patient monitoring
equipment with which it is interfaced.
• Use of the QS should not circumvent or take precedence over required patient care.
HIPAAConformance
GE Medical Systems is aware that complying with the Health Insurance Portability and Accessibility
Act (HIPAA) is a top priority as you work to meet transaction, security and privacy regulations.
Because these new regulations are an important step forward in protecting patient’s privacy and
improving efficiency within the healthcare industry, GE is actively engaged in providing information
to help you identify and resolve many of the patient care and business issues you may face as you
implement actions to comply with HIPAA.
You are encouraged to access the Internet URL listed below for the most recent information about
our commitment to HIPAA:
http://www.gemedicalsystems.com/it_solutions/hipaa/statement.html
QSFEATURES
The following paragraphs describe available QS features. Please note that some features are optional and
only available if specifically purchased.
ManualPatientDataRecording
User will generally enter data via electronic charts, forms, and/or chalkboards using a computer
keyboard. Although default charts, chalkboards and forms are provided for the QS, the QS Designer
tool provides appropriately trained site personnel to create their own or modify duplicates of the
default items to better suit the needs and requirements of their specific facility.
Clinically-related charts and forms may be combined into an appropriately labeled display group to
allow users to access the complete complement of charts suitable for the clinical tasks for which they
are responsible.
Charts
An electronic version of the traditional paper charts that clinicians once used to record patient
information. QS charts appear on the computer workstation display monitor and generally take the
form of tabular charts and flowsheets. Generally used to record recurrent data such as temperature,
blood pressure, etc., QS charts provide the maximum amount of patient information within a given
display.
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Forms
Forms are generally used to record data that does not vary with time. Demographic information
such as patient name, sex, date of birth, etc. is well suited for collection/display by QS forms.
Chalkboard
Similar to the white-boards used within individual hospital units to display patient (bed) status,
attending physician, lab results and other hospital defined information. The QS chalkboard offers
the advantage of being periodically updated with the latest data within the patient record.
MAR(MedicationAdministrationRecord)
The MAR allows transcription of medication and fluid orders into the QS using dedicated displays
and predefined order templates. Currently, there are four displays associated with the MAR - a
MAR display, an I&O Summary display, an Interventions display, and an Order Summary display.
AutomatedPatientDataRecording
Patient data may be automatically acquired from other hospital information systems and/or devices
that are interfaced with the QS system. The acquired data is automatically entered and saved with the
appropriate patient file(s) and may be subsequently retrieved for viewing within QS charts, forms and
chalkboards. Automated data recording combined with manual data entry allows the QS to maintain a
comprehensive patient record.
HospitalInformationSystems(HISs)
Automated information transfer (receipt and transmission) is possible if the QS is networked with
laboratory, ADT (admit, discharge and transfer), or other information systems. User specified data
is acquired from the respective system(s) and is generally unidirectional in that it travels from the
HIS system to the QS database. In some configurations, equipped with the HL7 Outbound feature
and/or Spacelabs Ultraview Gateway, the QS will serve as either the source of information or a
request for information. The QS interface conforms to the HL7 standard - an application level
specification for electronic data exchange in healthcare environments.
Devices
The QS is able to acquire data from physiologic monitors and bedside devices equipped with the
ability to send data to another system (e.g. via RS-232 connection). Data flow is essentially
unidirectional from the device to the QS (except for configurations making use of the Lab Access
Server or Unity Time Synchronization). The QS provides no controls to the interfaced monitor or
device. Device interfaces are consistent with the data transmission protocol established by the
device manufacturer. These protocols are governed by industry standards for data transmission.
The acquired data is in the form of parametric data (e.g. blood pressure values) or waveform data.
Acquired data recorded within the electronic patient record is available for historical review as
well as real-time surveillance capability (fetal monitor waveform data only).
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FetalHeartRate(FHR)Notifications
Sites may choose to use either of two available forms of fetal surveillance.
One, FHR Notifications provides both visual and audible indications that a monitored fetal heart rate
(FHR) is either above (high) or below (low) site/user defined limits or missing (poor signal quality).
These indicators are based upon parameters acquired directly from the interfaced monitor.
The other, Spectra Alerts analyzes FHR and uterine activity (UA) using a set of sophisticated internal
algorithms to determine the type and level of alert appropriate for the current fetal state. When
appropriate, the QS will generate both visual and audible alerts appropriate for the evaluated fetal
state.
PrintingandFaxing
Patient information (e.g. tabular charts, flowsheets and forms) as well as system configuration data
(used to define the QS operation as well as item, chart, and form definitions) may be printed either on
receipt of a user initiated demand or in accordance with a predefined printing schedule. The printed
output may be sent to any properly printer or fax machine (optional) configured to work with the QS.
IndexCalculator
The index calculator permits users to enter formulas and perform mathematical and scientific
calculations.
Compute
Compute consists of preset formulas that permit the user to perform nutrition, and drug related
calculations. The formulas are based on known, published formulas.
On-lineHelp
On-line help allows users to access information about a particular QS operation or feature. This is
similar to the Help feature in common software applications like Microsoft Word.
Security
Password, login requirements, validation requirements and assigned service categories are defined by
the site's System Manager(s).
Export
This feature permits the export of ASCII formatted patient data into a relational database (MS Access)
for quality assurance, reporting and research purposes. Operation of the relational database is separate
from the QS system.
Archive
Archive permits patient data (files) to be permanently saved to an alternative storage medium
(currently CD-R).
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QSARCHITECTURE
Figure 1 shows the QS in the context of a typical hospital system. Healthcare providers interact with the
user interface to review and modify patient data and system configuration data. ADT, Lab, and bedside
physiological monitors send data to the QS which incorporates it into the electronic patient data record. OB
Link is a web-based solution to deliver and display fetal trace data and other patient data to remote client
web browsers through the Windows Internet Information Server (IIS).
QSUsers
(ClinicalStaff)
HealthInformationSystems
(ADT/ClinicalData)
LabSystems
MATERNAL/FETALMONIT O R
Bedside(Physiological)
Monitors
QS
ClinicalInformationSystem
SD
TFT450
ArchiveCD-R
Birthlogs
&
DataReports
Printer
Fax
ZERO
SILENCE
GRAPH
DISPLAY
NBP
POWER
ALL
ALARM
GO/STO P
ON/OFF
GO/STOP
SOLAR8000
m
PDUTXHWWH
OBLinkWorkstation
SolarLabAccess
(RemoteLocation)
Figure 1: QS Context Diagram
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The Solar Lab Access (SLA) interface allows for laboratory results to be sent to GEMS Solar 8000 or Dash
3000 monitors on the Unity network for display. Patient data can be stored on long-term storage media for
future retrieval, and may be exported to a third party database for cross-patient analysis. Patient and system
configuration data can be sent to printers either on demand or through performance of scheduled print jobs.
Figure 2 shows the major patient data interactions in the QS. Patient data can be charted or reviewed via
the primary user interface process, the QS Presentation Manager (QPM). QPM can present patient data in
different formats. The Fetal Monitoring Surveillance (FMS) displays fetal wave data and allows users to
annotate that data. The Chart interface presents patient data in a tabular chart. The Forms interface presents
data in a graphical format. The QS Chalkboard (QCB) interface is an electronic version of chalkboards
often found in hospitals at unit central stations, displaying site defined patient data for each unit bed. The
Chalkboard Data Services Server (CDSS) manages data that can be accessed via the chalkboard. The
Medication Administration Record (MAR) provides the ability to order and chart medications, intake and
output fluids.Patient data can also be received from external systems by the system interface process for
the Hospital Information System (HIS Inbound) and Patient Monitoring System (PMS).
ADT/Lab
Systems
Charting
Systems
Solar
Monitors
Monitors
Web
Browsers
SYSTEM
INTERFACES
HIS
Inbound/
Outbound
LAS
PMS
QSWEB
Internet
Info rmation
Server(IIS)
Patient
Files
FMS&
Patient
DataCache
PDATS
FMS Charts Forms MAR QCB
QSWeb
PMS
PFILS
CDATS
CDSS
QPM
Configuration
Data
QSServer/Tools
Processes
Designer
Roster
QPM
Queriesabout
patientsorgate
status
PDSS
QS
Processes
QPM& HIS
(ADT)
CCOW
Context
Manager
Se ntillion
Contextor
3rdParty
Ap plications
Figure 2: Major Patient Data Interactions within the QS
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UserIn terfa ce
USERS