GE Unity Network User manual

Unity Network®
Patient Data Server (PDS)
Software Version 1
2016777-001 Revision A
g
GE Medical Systems
Information Technologies
gemedical.com
NOTE:
The information in this manual only applies to Unity Network Patient Data Server software version 1. Due to continuing product innovation, specifications in this manual are subject to change without notice.
Listed below are GE Medical Systems Information Technologies trademarks used in this manual. All other trademarks contained herein are the property of their respective owners.
APEXPRO, DASH, EAGLE, SOLAR, and UNITY NETWORK, are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office.
CIC PRO, CD TELEMETRY®–LAN, CENTRALSCOPE, ICMMS, OCTACOMM, and OCTANET are trademarks of GE Medical Systems Information Technologies.
© GE Medical Systems Information Technologies, 2003. All rights reserved.
T-2 Unity Network Patient Data Server Revision A
2016777-001 9 October 2003
CE Marking Information
CE Marking Information
Compliance
The Unity Network Patient Data Server application bears CE mark CE-0459 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. The product is in radio­interference protection class A in accordance with EN 55022.
The country of manufacture can be found on the equipment labeling.
The product complies with the requirements of standard EN 55024.
The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. See user’s information.
Exceptions
The Unity Network Patient Data Server EMC: Immunity Performance
There are no Safety and/or EMC compliance exceptions with this product.
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 the EMI performance. Consult with qualified personnel regarding changes to the system configuration.
Revision A Unity Network Patient Data Server CE-1
2016777-001
General Information
This manual is an integral part of the product and describes its
The symbol means ATTENTION: Consult accompanying
Information which refers only to certain versions of the product is
The warranty does not cover damages resulting from the use of
GE Medical Systems Information Technologies is responsible for the
CE Marking Information
intended use. It should always be kept close to the care giver using the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.
documents.
accompanied by the model number(s) of the product(s) concerned. The model number is given on the nameplate of the product.
accessories and consumables from other manufacturers.
effects on safety, reliability, and performance of the product, only if:
assembly operations, extensions, readjustments, modifications,
or repairs are carried out by persons authorized by GE Medical Systems Information Technologies;
the electrical installation of the relevant room complies with the
requirements of the appropriate regulations; and,
All publications conform with the product specifications and
applicable IEC publications on safety and essential performance of electromedical equipment as well as with applicable UL and CSA requirements and AHA recommendations valid at the time of printing.
The quality management system complies with the international
standards ISO 9001 and EN 46001, and the Council Directive on Medical Devices 93/42/EEC.
CE-2 Unity Network Patient Data Server Revision A
2016777-001
Contents
1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Manual Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Manual Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Product References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Frequently Used Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Software Packages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Device Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5
2 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
For Your Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Underwriters Laboratories, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
3 Equipment Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Unity Network Patient Data Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Data Storage Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Overlapping Data Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
4 Patient Data Collection Scenarios . . . . . . . . . . . . . . . . . . 4-1
Admit/Discharge Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Collect Patient Data Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Admit with a PID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Admit without a PID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
Admit without a PID: Before Monitor Comes On-line . . . . . . . . . . . . . . . . . . . . . . . 4-5
Admit with PID: Monitor Off-line Before Discharge . . . . . . . . . . . . . . . . . . . . . . . . 4-6
No PID Before Discharge or Monitor Off-line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
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Patient Transport Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Patient Transport Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
PID Before Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
PID During Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Transport via TRAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Transport Via a Wireless Dash Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Patient Transfer Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Patient Transfer Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
Off-line Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Discharge After Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Pre-Admit Before Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Combination Mode Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Combination Mode Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Switch From Telemetry to Combo Mode and Back to Telemetry . . . . . . . . . . . . 4-17
Switch From Bedside to Combo Mode and Back to Bedside . . . . . . . . . . . . . . .4-18
Third-Party Acquisition Device Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Third-Party Acquisition Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Bedside Monitor/Unity Network ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Unity Network ID/Bedside Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Data Storage and Post Discharge Viewing Scenarios . . . . . . . . . . . . . . . . . . . . . 4-23
General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Data Storage Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
View 72 Hours of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Post Discharge Viewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Patient Re-admit after Discharge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
ii Unity Network Patient Data Server Revision A
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1 General
Revision A Unity Network Patient Data Server 1-1
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For your notes
1-2 Unity Network Patient Data Server Revision A
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About This Manual
Manual Purpose
This manual contains the instructions necessary to understand how to use the Unity Network Patient Data Server (henceforth called PDS or the patient data server) safely and in accordance with its function and intended use.
This guide should be used in conjunction with the CIC Pro V4.0 (or greater) Operator's Manual which details how to view the information stored by the PDS.
Intended Audience
The manual is geared for clinical professionals. Clinical professionals are expected to have a working knowledge of medical procedures, practices and terminology as required to monitor critically ill patients.
General: About This Manual
Revision History
The PDS is intended to be used with the CIC Pro V4.0 and other GEMS devices that reside on the Unity Network MC. It is assumed that users of this product are familiar with using the CIC Pro and other applicable GEMS medical devices connected to the Unity Network MC and understand how to admit, discharge and move patients.
Each page of the document has the document part number and revision letter at the bottom of the page. The revision letter changes whenever the document is updated.
Revision Date Comments
A 9 October 2003 Initial release of this document.
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Manual Conventions
This section describes terminology, standards, and other conventions that are used throughout this manual.
Product References
The CIC Pro Clinical Information Center is referred to as the
CIC Pro.
A patient’s identification or medical record number is referred to as
PID.
The Unity Network MC network is referred to as Unity Network.
The Unity Network ID Connectivity Device is referred to as Unity
Network ID.
The Unity Network Patient Data Server is referred to as PDS or
patient data server.
Frequently Used Terms
General: Manual Conventions
Software Packages
Acquisition Device—A device used to acquire patient parameters
which connects to the Unity Network (e.g. Dash/Solar monitors, Telemetry transmitters, etc.).
Admit—The admit option on the acquisition device or CIC Pro has
been selected.
Association Mode—Association mode allows the connection of
non-GEMS devices to a monitor for consolidated viewing and data transmission.
Combo Mode—Combination mode is utilizing telemetry transmitters
to acquire parameters that are displayed at the bedside monitor.
Discharge—The discharge option on the acquisition device or
CIC Pro has been selected.
Monitoring Session—The data gathered by an acquisition device
from admit to discharge.
On-line—The acquisition device is connected (wired or wireless) to
the Unity Network.
PDS Enabled Device—A device that has been configured by the PDS
system to record its data.
The PDS server software includes the Unity Network Patient Data Server (PDS) V1.
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Device Compatibility
General: Manual Conventions
The PDS server will collect patient data from the following GE Medical Systems Information Technologies monitoring products. Any other Unity Network compatible products will function per design without any interaction with the PDS. Please contact GE Medical Systems Information Technologies if you want to connect a device that is compatible but has a software version not listed.
Product Software
ApexPro
telemetry system
1.7, 2.0, 2.1, 2.2, 3.0.4
*CDT-LAN telemetry system (combo mode only) 5H, 6A. 6C, 6CA, 6D, 6DA
Dash 2000 patient monitor 1A, 2A, 2B, 3A
Dash 3000/4000 patient monitor 2B, 2C, 3A, 3B, 3C, 3D, 4A, 4B, 4C
Eagle 4000 patient monitors 6G
Octacomm connectivity device 2A, 2B, 2C, 2D, 2E
Solar
7000/8000 patient monitors
7000/8000 patient monitors
Solar
4C special
3C, 4B, 5B, 5D, 5E, 6A, 7B, 7C
Solar 8000M patient monitors 1A, 1B, 1C, 2A, 3D, 4C, 4D
Solar 9500 patient monitors S9500-3A (S95)
Unity Network ID connectivity device 1A, 2A
*Octanet connectivity device 1A, 1B, 2A
CIC Pro clinical information center 4.0
* Devices are only supported when used with a compatible acquisition device.
NOTE
This list is subject to change without notice.
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For your notes
General: Manual Conventions
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2 Safety
Revision A Unity Network Patient Data Server 2-1
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For your notes
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For Your Safety
Intended Use
Terminology
Safety: For Your Safety
The Unity Network Patient Data Server is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity Network Patient Data Server is to provide centralized intermediate term storage of patient centric events and physiological data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Patient events and physiological data stored at the Unity Network Patient Data Server can be accessed via any (authorized) device that implements the PDS data exchange protocol. The Unity Network Patient Data Server is NOT intended to be the sole source for patient data and is to be used in conjunction with the data at the bedside monitor and central monitoring station.
The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with their definitions and significance.
Hazard is defined as a source of potential injury to a person.
DANGER
Indicates an imminent hazard which, if not avoided, will result in death or serious injury.
WARNING
Indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product/property damage.
NOTE
Provides application tips or other useful information to assure that you get the most from your equipment.
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Safety
Dangers
Warnings
Safety: For Your Safety
The safety statements presented in this chapter refer to the equipment in general and, in most cases, apply to all aspects of the product.
The order in which safety statements are presented in no way implies order of importance.
There are no dangers that refer to the equipment in general. Specific “Danger” statements may be given in the respective sections of this manual.
WARNING
ACCURACY — If the data is not available via the patient data server or the accuracy of the data is questionable, the caregiver should access the information at the primary beside monitor. The Unity Network Patient Data Server is NOT intended to be the sole source for patient data and is to be used in conjunction with the data at the bedside monitor and central monitoring station. The primary monitor should always be reference before making any patient care decisions.
PROPER ADMIT/DISCHARGE — Proper admit/ discharge procedures for the acquisition device must be followed to ensure that data from the different patients is not mixed.
UNIQUE PATIENT ID — Each patient identification number (PID) must be a unique series of characters so that data from more than one patient is not stored in a single record.
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Cautions
Safety: For Your Safety
CAUTIONS
INSTRUCTIONS FOR USE — For continued safe use of this equipment, it is necessary that the listed instructions are followed. However, instructions listed in this manual in no way supersede established medical practices concerning patient care.
NEGLIGENCE — GE Medical Systems Information Technologies does not assume responsibility for damage to the equipment caused by improperly loaded software, failure or data loss due to not using a UPS.
OPERATOR — Medical software such as this patient data server must only be used by persons who have received adequate training in the use of such software and who are capable of applying it properly.
RESTRICTED SALE — U.S. federal law restricts this device to sale by or on the order of a physician.
Underwriters Laboratories, Inc.
Medical Equipment With respect to electric shock, fire and mechanical hazards only in accordance with UL 1950-3, and CAN/CSA C22.2 NO. 950.
Revision A Unity Network Patient Data Server 2-5
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