GE Unity Network User manual

4.7 (3)
GE Medical Systems
Information Technologies
g
gemedical.com
Unity Network
®
Patient Data Server (PDS)
Software Version 1
2016777-001 Revision A
T-2 Unity Network Patient Data Server Revision A
2016777-001 9 October 2003
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.
Revision A Unity Network Patient Data Server CE-1
2016777-001
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 radio-
interference 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.
CE-2 Unity Network Patient Data Server Revision A
2016777-001
CE Marking Information
General Information
This manual is an integral part of the product and describes its
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.
The symbol means ATTENTION: Consult accompanying
documents.
Information which refers only to certain versions of the product is
accompanied by the model number(s) of the product(s) concerned.
The model number is given on the nameplate of the product.
The warranty does not cover damages resulting from the use of
accessories and consumables from other manufacturers.
GE Medical Systems Information Technologies is responsible for the
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.
Revision A Unity Network Patient Data Server i
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
ii Unity Network Patient Data Server Revision A
2016777-001
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
Revision A Unity Network Patient Data Server 1-1
2016777-001
1 General
1-2 Unity Network Patient Data Server Revision A
2016777-001
For your notes
Revision A Unity Network Patient Data Server 1-3
2016777-001
General: About This Manual
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.
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.
Revision History
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.
1-4 Unity Network Patient Data Server Revision A
2016777-001
General: Manual Conventions
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
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.
Software Packages
The PDS server software includes the Unity Network Patient Data
Server (PDS) V1.
Revision A Unity Network Patient Data Server 1-5
2016777-001
General: Manual Conventions
Device Compatibility
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.
* Devices are only supported when used with a compatible acquisition
device.
NOTE
This list is subject to change without notice.
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
4C special
Solar
7000/8000 patient monitors
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
1-6 Unity Network Patient Data Server Revision A
2016777-001
General: Manual Conventions
For your notes
Revision A Unity Network Patient Data Server 2-1
2016777-001
2 Safety
2-2 Unity Network Patient Data Server Revision A
2016777-001
For your notes
Revision A Unity Network Patient Data Server 2-3
2016777-001
Safety: For Your Safety
For Your Safety
Intended Use
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.
Terminology
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.
2-4 Unity Network Patient Data Server Revision A
2016777-001
Safety: For Your Safety
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.
Dangers
There are no dangers that refer to the equipment in general. Specific
“Danger” statements may be given in the respective sections of this
manual.
Warnings
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.
Revision A Unity Network Patient Data Server 2-5
2016777-001
Safety: For Your Safety
Cautions
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.
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