GE Centricity User manual

Centricity® Perinatal

Quantitative Sentinel

Service Manual

2002033-023 Revision E

GE Medical Systems Information Technologies

doing business as GE Healthcare

8200 West Tower Ave.

Milwaukee, WI 53223

United States of America

Customer Support Department—Americas and Southeast Asia

24-hour Emergency Toll-Free Service

Call 1-800-433-2009

Authorized Representative in the European Union

GE Medical Systems Information Technologies GmbH

Munzinger Strasse 3-5

Freiburg D79111

Germany

Tel. [phone]

Fax. [phone]

© 2003, 2006 General Electric Company. All rights reserved.

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 Technologies. 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® is a trademark owned by General Electric Company. All other marks are owned by their respective owners.

AirStrip OB® is a registered trademark of MP4 Solutions, LP.

Service Manual	Revision E
2002033-023

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
Security considerations ................................................................................................	xxiv
Service Information ..............................................................................................................	xxiv
Introduction to the Quantitative Sentinel (QS) System ........................................................	xxiv
User Interface ..............................................................................................................	xxiv
Interface Customization ...............................................................................................	xxv
Supported Interfaces ...................................................................................................	xxv
User Background .................................................................................................................	xxv
Disclaimers ..........................................................................................................................	xxv
Customer Responsibility for Medical Record ...............................................................	xxvi
Data Collection ............................................................................................................	xxvi
Design Changes ..........................................................................................................	xxvi
Patient Care .................................................................................................................	xxvi
References to Persons, Places, and Institutions .........................................................	xxvi
Reproduction Rights ....................................................................................................	xxvii
Chapter 1: QS System Overview
QS System Description .......................................................................................................	1
Capabilities ..................................................................................................................	1
Intended Users of the QS ............................................................................................	2
User Environment ........................................................................................................	2
Patient Applicability ......................................................................................................	2
HIPAA Conformance ...................................................................................................	2
Manual Patient Data Recording ...................................................................................	3
Charts ...............................................................................................................	3
Forms ...............................................................................................................	3

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Chalkboard .......................................................................................................	3
MAR .................................................................................................................	3
Automated Patient Data Recording .............................................................................	3
Hospital Information Systems (HISs) ...............................................................	4
Devices ............................................................................................................	4
Fetal Heart Rate (FHR) Notifications ...........................................................................	4
Printing and Faxing ......................................................................................................	5
Index Calculator ...........................................................................................................	5
Compute ......................................................................................................................	5
Online Help ..................................................................................................................	5
Security ........................................................................................................................	5
Export ..........................................................................................................................	5
Archive .........................................................................................................................	5
User Interface Facilities .......................................................................................................	9
QS Processes ......................................................................................................................	11
Archive .........................................................................................................................	11
Broadcast Relay ..........................................................................................................	12
CDATS .........................................................................................................................	12
CDSS ...........................................................................................................................	13
HIS ...............................................................................................................................	13
HL7Out ........................................................................................................................	14
Lab Access Server .......................................................................................................	14
LOGS ...........................................................................................................................	15
Patient Data Server .....................................................................................................	15
PDSS ...........................................................................................................................	16
PMS .............................................................................................................................	17
PtD ...............................................................................................................................	18
QPM .............................................................................................................................	18
SPP ..............................................................................................................................	18
System Functions ................................................................................................................	19
Log files .......................................................................................................................	19
Storage Configuration ..................................................................................................	20
Single Server Systems - Microsoft Windows NT ..............................................	20
Dual Server Systems (Microsoft Windows NT Only) ........................................	22
The archiving process ......................................................................................	25
The archive database .......................................................................................	26
Patient file size considerations .........................................................................	26
How Archive initializes compact discs ..............................................................	26
What happens when one of the CD-R drives is not operational ......................	27
CD-R life expectancy .......................................................................................	27
Other important things to know about Archive .................................................	27
Files used by Archive .......................................................................................	28
Archive Admin Commands ...............................................................................	29
QPM Restore ...................................................................................................	30
Problems restoring due to dirty CD drive or CD-R media problems ................	31
Printing .........................................................................................................................	31
Batch printing ..................................................................................................	31
Scheduled printing ...........................................................................................	32
QS Office Client ...........................................................................................................	33
OB Link ........................................................................................................................	33
QSWeb .............................................................................................................	34
Log files ............................................................................................................	35
Strings Files .....................................................................................................	35

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Strip chart applet and screen size applet .........................................................	36
Server Startup Process ................................................................................................	38
Utility Programs ...................................................................................................................	41
CDATDisp ....................................................................................................................	41
CDUpdate ....................................................................................................................	41
Designer ......................................................................................................................	41
QSCopy .......................................................................................................................	42
QSTest .........................................................................................................................	42
Chapter 2: Process Control & Status
QS Processes ......................................................................................................................	52
Process Arguments .............................................................................................................	53
Archive Arguments ......................................................................................................	53
SET ..................................................................................................................	53
SHOW ..............................................................................................................	54
BRelay Arguments .......................................................................................................	54
SET ..................................................................................................................	54
SHOW ..............................................................................................................	54
CDATS Arguments ......................................................................................................	55
SET ..................................................................................................................	55
SHOW ..............................................................................................................	55
CDSS Arguments ........................................................................................................	55
SET ..................................................................................................................	55
SHOW ..............................................................................................................	56
HIS-HL7 (Inbound) Arguments ....................................................................................	56
SET ..................................................................................................................	56
HIS-HL7O (Outbound) Arguments ...............................................................................	56
SHOW ..............................................................................................................	56
SET ..................................................................................................................	56
LAS Arguments ............................................................................................................	57
SET ..................................................................................................................	57
SHOW ..............................................................................................................	57
LOGS Arguments ........................................................................................................	57
SET ..................................................................................................................	57
SHOW ..............................................................................................................	57
PDATS Arguments ......................................................................................................	57
SET ..................................................................................................................	57
SHOW ..............................................................................................................	58
PDSS Arguments .........................................................................................................	58
SET ..................................................................................................................	58
SHOW ..............................................................................................................	58
PFILS Arguments ........................................................................................................	59
SET ..................................................................................................................	59
SHOW ..............................................................................................................	59
PMS Arguments ...........................................................................................................	60
SET ..................................................................................................................	60
SHOW ..............................................................................................................	62
PtD Arguments ............................................................................................................	62
SET ..................................................................................................................	62
QPM Arguments ..........................................................................................................	63
CYCLE .............................................................................................................	63
SET ..................................................................................................................	63

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SHOW ..............................................................................................................	63
QSConnect Arguments ................................................................................................	63
SHOW ..............................................................................................................	63
SET ..................................................................................................................	63
SPP Arguments ...........................................................................................................	64
SHOW ..............................................................................................................	64
SET ..................................................................................................................	64
Chapter 3: Network Architecture
Network Performance ..........................................................................................................	65
Fetal Monitor Communication ..............................................................................................	67
Equinox Equipment .............................................................................................................	69
Digi Equipment ....................................................................................................................	75
QS Traffic ............................................................................................................................	77
Broadcast Traffic ..........................................................................................................	77
Network Bandwidth ......................................................................................................	77
Network Latency ..........................................................................................................	78
QS Item Size ................................................................................................................	78
Local Area Network .............................................................................................................	79
Wide-Area Network .............................................................................................................	80
Network Recommendations ................................................................................................	81
Server ..........................................................................................................................	81
Equinox (100Base-T) ...................................................................................................	81
Equinox (10Base-T) .....................................................................................................	81
Workstation ..................................................................................................................	81
Network Configuration: Information and Guidelines ............................................................	82
Time synchronization ...................................................................................................	82
Network Device Configuration .....................................................................................	83
When to Use Ethernet 10/100Mb Auto-Negotiation .....................................................	83
Why Do Auto-Negotiation and Compatibility Issues Exist? .........................................	84
General Troubleshooting for 10/100 Mbps NICs .........................................................	84
Why Can't the Speed and Duplex Be Hard-Coded On Only One Link Partner? .........	85
Recommended Port Configuration (Auto-Negotiation or Manual Configuration) 85
Understanding Data Link Errors .......................................................................	86
NIC Compatibility and Operational Issues ...................................................................	86
Yellow Bars on the QS Fetal Display ...........................................................................	91
What is a Yellow bar? ......................................................................................	91
Why is it yellow? ...............................................................................................	92
When are they displayed? ................................................................................	92
What are the known causes? ...........................................................................	92
What are the known fixes? ...............................................................................	93
Vendor Access to the QS System .......................................................................................	94
Interfaces .............................................................................................................................	95
Serial Cable Specifications ..........................................................................................	95
Copper room-to-concentrator ...........................................................................	95
Copper concentrator-to-concentrator/concentrator-to-host adapter card .........	95
Fiber optic concentrator-to-concentrator/concentrator-to-host adapter card ....	95
Ethernet Cable Specifications .....................................................................................	96

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IP Communication: Network Traffic .....................................................................................	96
The QS System and the Hospital Network Environment .....................................................	97
Unity Equipment ..................................................................................................................	97
Interface Devices .........................................................................................................	97
Octanet ........................................................................................................................	97
NT Issues ............................................................................................................................	99
User Accounts and Security .............................................................................	99
Workgroup versus Domain ...............................................................................	99
Third Party Applications ...................................................................................	99
Static IP Addresses and DHCP ........................................................................	100

Chapter 4: Software Considerations

Software Installation ............................................................................................................	101
Prerequisites ................................................................................................................	102
Server Workstation ......................................................................................................	105
Assumptions ................................................................................................................	106
Installation with the InstallShield ..................................................................................	106
Installation procedure from the command line .............................................................	110
Software Upgrades ..............................................................................................................	112
Upgrade Process .........................................................................................................	112
Release Notes ..................................................................................................	112
Additional costs ................................................................................................	112
Installation ........................................................................................................	112
Upgrading sites not under warranty (without a valid SSA) ...............................	113
Upgrading sites under warranty (with a valid SSA) ..........................................	113
Upgrade Preparation Checklist ....................................................................................	114

Chapter 5: Preventive Maintenance

GE Recommendations ........................................................................................................	119
Database Maintenance ........................................................................................................	120
The QS and Third Party Software .......................................................................................	121
GE Healthcare Information Technologies Anti-Virus Software Policy .........................	121
Global Virus Scanning .................................................................................................	122
Files that should be scanned ...........................................................................	122
Known anomalies .............................................................................................	123
Norton Anti-Virus 8.0 Client .........................................................................................	127
For ALL Systems ..............................................................................................	127
For primary/backup/cluster servers with Microsoft Windows 2000 or 2003 operating system
127
For primary/backup servers with Microsoft Windows NT4 operating system ...	127
For all servers and all QS client workstations regardless of operating system	128
Patches ................................................................................................................................	128
GE Healthcare Information Technologies Security Patches Policy .............................	128
Microsoft Patches ........................................................................................................	129
Licensing .............................................................................................................................	130
6.70.5 Release Specifications .............................................................................................	130
Server Specifications ...................................................................................................	130
Client Workstation Specifications ................................................................................	131
Additional Requirements for Perinatal Installations .....................................................	131

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Chapter 6: Data Backup
Source of Backup Tools ......................................................................................................	133
Data Backup Responsibility .................................................................................................	133
Important Considerations ....................................................................................................	133
Chapter 7: System Failover
Verify Backups to the BKSEVER .........................................................................................	135
Failover Process for a Single Server ...................................................................................	136
Failover Process for Cluster Servers ...................................................................................	136
Sequence for shifting cluster resources between nodes .............................................	136
To shift cluster resources between nodes ........................................................	136
Stopping and starting the QS on the cluster server .....................................................	137
To stop the QS System ....................................................................................	137
To restart the QS System .................................................................................	138
To restart QS System after a power loss .........................................................	138
Chapter 8: Disaster Recovery
Environment and Assumptions ............................................................................................	139
Disaster Recovery Staging Drive (K:) ..........................................................................	139
Guidelines for the staging drive ........................................................................	139
Size requirements for the staging drive ............................................................	140
Cluster server requirements for the staging drive ............................................	140
Single server requirements for the staging drive ..............................................	140
Hardware and Software Requirements ........................................................................	141
Networking Requirements ................................................................................	141
Digi devices ......................................................................................................	141
Secondary Storage Requirements ...................................................................	141
Setting up the Disaster Recovery Environment ...................................................................	142
Customer-Responsible Items ......................................................................................	142
Secondary Storage Drive .................................................................................	142
Staging Drive ....................................................................................................	142
Backup Interval ................................................................................................	142
Data Purging on the Secondary Storage Device .............................................	142
Recovering from a Disaster .................................................................................................	143
Backup Server .............................................................................................................	143
Replacement Server ....................................................................................................	143
Known Deficiencies .............................................................................................................	143
Country Code ...................................................................................................	143
WAN Distance ..................................................................................................	143
Node separation of Clusters using Fibre ..........................................................	143
Miscellaneous Information ...................................................................................................	144
Size requirements for various Drives ...............................................................	144
Geographical separation ..................................................................................	144

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Appendix A: Glossary of Network Terms
Appendix B: Sample Network Diagrams
Appendix C: Fetal Monitor Set-Up
Corometrics® 115 ................................................................................................................	159
Corometrics® 116 ................................................................................................................	161
Corometrics® 118 ................................................................................................................	163
Corometrics® 120 Series ....................................................................................................	164
Corometrics® 145 ................................................................................................................	164
Corometrics® 150 ................................................................................................................	164
Corometrics® 151 ................................................................................................................	165
RS232 SETUP .............................................................................................................	165
Configuration of the RS-232 Port .................................................................................	165

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Corometrics® 170 Series ....................................................................................................	166
Hewlett Packard/Philips Series 50 (1350, 1351, 1353) .......................................................	167
Hewlett Packard 8040 .........................................................................................................	168
Hewlett Packard 8041 .........................................................................................................	168
Spacelabs MOM™ model 94000 .........................................................................................	168
Appendix D: Unity Parameters
Allied Health Care Bear 1000 ..............................................................................................	170
Baxter Vigilance ...................................................................................................................	170
Bird VIP ...............................................................................................................................	171
Datex Capnomac .................................................................................................................	172
Dräger Babylog 8000 ...........................................................................................................	172
Dräger Cato .........................................................................................................................	173
Dräger Evita .........................................................................................................................	174
Dräger Evita 2 ......................................................................................................................	175
Dräger Evita 2 Dura .............................................................................................................	177
Dräger Evita 4 ......................................................................................................................	178
Dräger Julian .......................................................................................................................	179
Dräger PM8060 ...................................................................................................................	180
Engstrom Elsa .....................................................................................................................	181
Hamilton Veolar ...................................................................................................................	182
Hellige SMU EVO ................................................................................................................	183
Nellcor Puritan Bennet Adult Star 950 / 1500 / 2000 ...........................................................	184
Nellcor Puritan Bennet Infant Star .......................................................................................	185
Nellcor Puritan Bennet Infant Star 500 ................................................................................	186
Nellcor Puritan Bennet Infant Star 950 ................................................................................	186
Nellcor Puritan Bennet pb7200 ............................................................................................	187
Sechrist 600APM .................................................................................................................	188
Siemens SC 9000 ................................................................................................................	188
Servo 300 ............................................................................................................................	190
Siemens Servo 900 .............................................................................................................	190
Appendix E: QS Versions
Appendix F: QS & Other Documents
QS Documentation ..............................................................................................................	193
Microsoft Windows NT & Microsoft Windows 2000 .............................................................	194
Networking ...........................................................................................................................	194
Appendix G: Citrix Support
Customer Requirements ......................................................................................................	195
System Requirements .........................................................................................................	195
Operating System ........................................................................................................	195
Software .......................................................................................................................	196
Hardware .....................................................................................................................	196
Microsoft Windows 2003 Server ..................................................................................	196
Network ........................................................................................................................	196

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Documentation ....................................................................................................................	196
Configuration .......................................................................................................................	197
Notes ...................................................................................................................................	197
IPs and User Accounts ........................................................................................................	198
Create Virtual IPs .........................................................................................................	198
Add and Configure Citrix Users ...................................................................................	198
INDEX .................................................................................................................................	203

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Quantitative Sentinel® Service Manual
List of Figures
Figure Title	Page Number
QS Context Diagram......................................................................................................	6
Major Patient Data Interactions within the QS..............................................................	7
Ancillary QS Processes..................................................................................................	9
Single Server Disk Configuration - Microsoft Windows NT ......................................	21
Single Server Disk Configuration - Microsoft Windows 2000 and 2003....................	22
Dual Server - Disk Configuration................................................................................	23
Archive Data Flow.......................................................................................................	25
Printer Configuration for Batch and Scheduled Printing.............................................	32
OB Link Fetal Strip Display ........................................................................................	34
QS Server Startup Process ...........................................................................................	39
QS Client Startup Process............................................................................................	40
Network Commands Dialog Box.................................................................................	51
Old Isolation Interface Units........................................................................................	67
New Isolation Interface Units ......................................................................................	68
Wall Plate to Patch Panel 568A (Equinox)..................................................................	70
Wall Plate to Patch Panel 568B (Equinox)..................................................................	71
Wall Plate to Patch Panel 568B Shielded (Equinox)...................................................	72
Monitor to Wall Plate ..................................................................................................	73
Monitor to Switch Diagram .........................................................................................	74
Two Port ESP OC ........................................................................................................	74
Wall Plate to Patch Panel 568B Shielded (Digi) .........................................................	76
Typical LAN Configuration.........................................................................................	79
Typical WAN Configuration .......................................................................................	80
Example of a Yellow Bar.............................................................................................	91
Unity to Dash 3000/4000 Monitor Interface................................................................	98
Unity to Solar 9500 Monitor Interface ........................................................................	98
Unity to Solar 8000M Monitor Interface.....................................................................	99
Preparing to Install Dialog Box .................................................................................	106
Welcome to the InstallShield Wizard for QS Clinical Information System
Dialog Box.................................................................................................................	107
Workstation Install Dialog Box .................................................................................	107
Ready to Install the Program Dialog Box..................................................................	108
Installing QS Clinical Information System Dialog Box ............................................	109
InstallShield Wizard Completed Dialog Box ............................................................	109
QS Clinical Information System Installer Information Dialog Box ..........................	110

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Quantitative Sentinel® Service Manual

Norton Antivirus Corporate Edition - Initial Dialog .................................................	124
Initial Scan Dialog .....................................................................................................	125
Scan Dialog - File Listing..........................................................................................	125
Scan Options Dialog ..................................................................................................	126
Select Items Dialog....................................................................................................	126
HL7 Solar Lab Access Configuration........................................................................	150
Intensive Care Configuration - Single Unit ...............................................................	151
Intensive Care Configuration - Multiple Units ..........................................................	152
Surveillance Configuration - Single Unit ..................................................................	153
Surveillance Configuration with Equinox Concentrator - Multiple Units.................	154
Surveillance Configuration - Wide Area Network (WAN) .......................................	155
Surveillance Configuration (WAN) - Primary & Remote Sites ................................	156
Surveillance Configuration WAN-Ring ....................................................................	157
Corometrics® 116 Set-up ..........................................................................................	162
Corometrics® 118 Set-up ..........................................................................................	163

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Revision E

Quantitative Sentinel® Service Manual
List of Tables
Table Tile	Page Number
Revision History ..........................................................................................................	xv
Section Contents ........................................................................................................	xvi
Type Convention Definitions.....................................................................................	xix
Customer Support Phone Numbers..........................................................................	xxiv
What the server partitions include ...............................................................................	20
Example of a Directory Structure ................................................................................	24
Content of the QS Tools File .......................................................................................	43
Network Commands Dialog Box - Component Descriptions .....................................	52
Estimated IP Traffic.....................................................................................................	78
Auto-Negotiation Valid Configuration Table..............................................................	84
NIC Troubleshooting ...................................................................................................	86
Client Workstation Requirements..............................................................................	102
Server Workstation Requirements .............................................................................	103
Network Requirements ..............................................................................................	104
Tools Version Applicability.......................................................................................	105
Installation Command Parameters .............................................................................	110
Example Upgrade Preparation Checklist...................................................................	114
Corometrics 115 Dip Switch Settings - Switch SW1 ................................................	159
Corometrics 115 Dip Switch Settings - Switch SW2 ................................................	160
Corometrics 115 Dip Switch Settings - Switch SW3 ................................................	160
Corometrics® 151 RS-232 Port Configuration Settings ...........................................	165
Corometrics® 170 Series Service Codes...................................................................	166
Parametric Data - Allied Health Care Bear 1000.......................................................	170
Parametric Data - Baxter Vigilance ...........................................................................	170
Parametric Data - Bird VIP........................................................................................	171
Parametric Data - Datex Capnomac...........................................................................	172
Parametric Data - Dräger Babylog 8000....................................................................	172
Parametric Data - Dräger Cato...................................................................................	173
Parametric Data - Dräger Evita..................................................................................	174
Parametric Data - Dräger Evita 2...............................................................................	175
Parametric Data - Dräger Evita 2 Dura......................................................................	177
Parametric Data - Dräger Evita 4...............................................................................	178
Parametric Data - Dräger Julian.................................................................................	179

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List of Tables
Table Tile	Page Number
Parametric Data - Dräger PM8060 ............................................................................	180
Parametric Data - Engstrom Elsa...............................................................................	181
Parametric Data - Hamilton Veolar ...........................................................................	182
Parametric Data - Hellige SMU EVO........................................................................	183
Parametric Data - Nellcor Puritan Bennet Adult Star 950 / 1500 / 2000...................	184
Parametric Data - Nellcor Puritan Bennet Infant Star ...............................................	185
Parametric Data - Nellcor Puritan Bennet Infant Star 500 ........................................	186
Parametric Data - Nellcor Puritan Bennet Infant Star 950 ........................................	186
Parametric Data - Nellcor Puritan Bennet pb7200 ....................................................	187
Parametric Data - Sechrist 600APM..........................................................................	188
Parametric Data - Siemens SC 9000..........................................................................	188
Parametric Data - Servo 300......................................................................................	190
Parametric Data - Siemens Servo 900 .......................................................................	190
QS Versions as they Relate to Servers and Workstations .........................................	191
QS Documentation.....................................................................................................	193

REF 2002033-023	xiv
Revision E

Preface

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)

•Referenced documentation (page xvii)

•Related documentation (page xvii)

Revision history

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
Revision	Date	Version	Comment
A	March 2003	6.60.0	Initial release.
B	March 2005	6.70.0	Updated for new
			release—includes addi-
			tion of index.
C	July 2005	6.70.1	Added the System
			Failover chapter and
			made minor changes.

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Preface - Document Information

Table 1: Revision History

		Software
Revision	Date	Version	Comment
D	October 2005	6.70.5	Updated for new
			release—includes addi-
			tion of Anti-Virus Soft-
			ware Policy, Security
			Patches Policy and
			Database Maintenance
			information. Used for
			the Pilot.
E	January 2006	6.70.5	Added Citrix Support
			appendix and updated
			the Preface.

Chapter contents

This document is organized into several chapters. These sections are described in the Section Contents table.

Table 2: Section Contents

Name	Contents
Chapter 1: QS System Overview	Describes the QS system, it’s function,
	features, processes, and archeteci-
	ture. Also describes the user interface
	facilities, utility programs and tools.
Chapter 2: Process Control &	Describes QS processes and process
Status	arguments.
Chapter 3: Network Architecture	Describes the two types of networks
	necessary for communication between
	QS servers and clients and the QS
	Patient Monitoring System (PMS).
Chapter 4: Software Consider-	Describes software installation and
ations	upgrades.
Chapter 5: Preventive Maintenance	Describes the cleaning and periodic
	servicing of the 3rd party equipment
	that hosts and supports the operation
	of the QS system.
Chapter 6: Data Backup	Describes the importance of having a
	data backup application.
Chapter 7: System Failover	Describes backup servers and the
	failover process for single and cluster
	servers.

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Preface - Document Information

Table 2: Section Contents

Name	Contents
Chapter 8: Disaster Recovery	Describes 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 disas-
	ter.
Appendix A: Glossary of Network	List of terms used to describe a net-
Terms	work.
Appendix B: Sample Network Dia-	Illustrates a collection of diagrams rep-
grams	resents but a small number of the net-
	work configurations that are possible
	in the QS.
Appendix C: Fetal Monitor Set-Up	Describes information necessary for
	interfacing fetal monitors with the QS.
Appendix D: Unity Parameters	Provides parameter descriptions and
	the identity of the corresponding QS
	PMS items.
Appendix E: QS Versions	Describes the various versions of the
	QS system and the operating systems
	that support them.

Appendix F: QS & Other Documents

Lists a number of additional publications that may help you in understanding and supporting the QS system.

Referenced documentation

There are no referenced documentation in this manual.

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.

•Centricity Perinatal Customer-Supplied Equipment Guide, 2002033-045

•6.70.5 Release Notes

•AirStrip OB® System Administration Guide

•AirStrip OB® User’s Guide

Quantitative Sentinel® interfaces with AirStrip OB, a third-party 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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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

Convention	Description
Sans-serif bold	The information in bold sans-serif type refers to a
type	component name on the screen. For example, click
	OK refers to the OK button on the dialog box.
SANS-SERIF SMALL	Keys that you press on the keyboard are displayed
CAPS	in this font. For example, press ENTER refers to the
	Enter key on the keyboard.
Monospace type	Information that you type on the keyboard is dis-
	played in this font. Examples of code (software
	source code) are displayed in monospace font
	also.
Monospace ital-	In software source code examples, monospace
ics type	italics are used for code comments.
Italic type	Information in italics is used when discussing a
	variable. Any font style, excluding the monospace
	styles, can be italicized for this purpose.

Intended Use

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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•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.

What do you want to learn about?

•Potential Electrical/Mechanical/Physical Hazards (page xx)

•Internet and intranet considerations (page xxii)

•Surveillance and monitoring concerns (page xxii)

•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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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 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 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 Notifications 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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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

Area	Phone Number
Within US	1-800-433-2009
Outside US	[phone]

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.

Supported Interfaces

The QS system employs Microsoftand 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).

User Background

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.

Disclaimers

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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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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