GE Medical Systems Information Technologies Users Manual
Specifications and Main Features
Frequently Asked Questions
User Manual
ApexPro
™
Telemetry System
Operator’s Manual
Software Version 3
2001989-134Revision D
NOTE:
The information in this manual only applies to ApexPro Telemetry System software version 3. It does not
apply to earlier software versions. Due to continuing product innovation, specifications in this manual are
subject to change without notice.
Listed below are GE Medical Systems Information Technologies trademarks. All other trademarks contained
herein are the property of their respective owners.
APEX, ApexPro, DINAMAP Pro, and UNITY NETWORK are trademarks of GE Medical Systems
Information Technologies registered in the United States Patent and Trademark Office.
CD Telemetry
®
-LAN, CIC Pro, IMPACT.wf, PRN 50 are a trademarks of GE Medical Systems Information
The ApexPro telemetry system bears CE mark CE-0459 indicating
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 radio-interference protection
class A in accordance with EN 55011.
The country of manufacture can be found on the equipment labeling.
The product complies with the requirements of standard EN 60601-1-2
“Electromagnetic Compatibility-Medical Electrical Equipment.”
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.
Revision DApexPro Telemetry SystemCE-1
2001989-134
CE Marking Information
Exceptions
The CIC Pro and ApexPro server is suitable for use in the specified
electromagnetic environment. The customer and/or the user of the CIC
Pro and ApexPro server should assure that it is used in an
electromagnetic environment as described below:
36.202.1 Immunity: ESDDirect - Discharges of 6 KV or greater to the
rear I/O connector area may cause the system
to lock up, thus experiencing loss of data and
loss of functionality. Operator intervention may
be required.
Likelihood of occurrence: Remote
During testing there were 2 occurrences out of
1,920 discharges.
The rear I/O connector area is not considered
to be user accessible during normal operation.
36.202.3.1 Immunity: Fast Transient Transients on the AC power line of +/- 1 KV or
higher may cause momentary network packet
loss (i.e. waveform and/or numeric data), thus
experiencing momentary loss of data at the
time of the surge.
36.202.3.2 Immunity: Fast SurgesSurges on the AC power line of +/- 1 KV or
higher may cause momentary network packet
loss (i.e. waveform and/or numeric data), thus
experiencing momentary loss of data at the
time of the surge.
Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Mains power quality should be that of a typical
commercial and/or hospital environment.
Mains power quality should be that of a typical
commercial and/or hospital environment.
36.202.2 Immunity: Radiated FieldsIf operated in the midst of the conditions
outlined in EMC standard EN60601-1-2
(Radiated Immunity 3 V/m), fields in excess of
1 V/m may cause waveform distortions and
erroneous numeric data at various
electromagnetic interference (EMI)
frequencies.
ApexPro Antenna System
36.202.2 Immunity: Radiated FieldsIf operated in the midst of the conditions
outlined in EMC standard EN60601-1-2
(Radiated Immunity 3 V/m), fields in excess of
0 V/m in the frequency ranges of 520-534
MHz and 645-660 MHz may cause loss of
telemetry.
Review the AAMI EMC Committee technical
information report (TIR-18) titled Guidance
on electromagnetic compatibility of medical
devices for clinical/biomedical engineers Part 1: Radiated radio-frequency
electromagnetic energy. This TIR provides
a means to evaluate and manage the EMI
environment in the hospital.
Manage (increase) distance between
sources of EMI and susceptible devices.
Manage (remove) devices that are highly
susceptible to EMI.
Lower power from internal EMI sources
under hospital control (i.e., paging
systems).
Label devices susceptible to EMI.
Educate staff (nurses and doctors) to be
aware of, and to recognize, potential EMI
related problems.
Review the AAMI EMC Committee technical
information report (TIR-18) titled Guidance
on electromagnetic compatibility of medical
devices for clinical/biomedical engineers Part 1: Radiated radio-frequency
electromagnetic energy. This TIR provides
a means to evaluate and manage the EMI
environment in the hospital.
Manage (increase) distance between
sources of EMI and susceptible devices.
Manage (remove) devices that are highly
susceptible to EMI.
Lower power from internal EMI sources
under hospital control (i.e., paging
systems).
Label devices susceptible to EMI.
Educate staff (nurses and doctors) to be
aware of, and to recognize, potential EMI
related problems.
36.202.2 Immunity: Radiated FieldsIf operated in the midst of the conditions
outlined in EMC standard EN60601-1-2
(Radiated Immunity 3 V/m), fields in excess of
0.5 V/m may cause waveform distortions and
erroneous numeric data at various
electromagnetic interference (EMI)
frequencies.
Xpod Oximeter
36.202.2 Immunity: Radiated FieldsIf operated in the midst of the conditions
outlined in EMC standard EN60601-1-2
(Radiated Immunity 3 V/m), fields in excess of
1 V/m may cause waveform distortions and
erroneous numeric data at various
electromagnetic interference (EMI)
frequencies.
Review the AAMI EMC Committee technical
information report (TIR-18) titled Guidance
on electromagnetic compatibility of medical
devices for clinical/biomedical engineers Part 1: Radiated radio-frequency
electromagnetic energy. This TIR provides
a means to evaluate and manage the EMI
environment in the hospital.
Manage (increase) distance between
sources of EMI and susceptible devices.
Manage (remove) devices that are highly
susceptible to EMI.
Lower power from internal EMI sources
under hospital control (i.e., paging
systems).
Label devices susceptible to EMI.
Educate staff (nurses and doctors) to be
aware of, and to recognize, potential EMI
related problems.
Review the AAMI EMC Committee technical
information report (TIR-18) titled Guidance
on electromagnetic compatibility of medical
devices for clinical/biomedical engineers Part 1: Radiated radio-frequency
electromagnetic energy. This TIR provides
a means to evaluate and manage the EMI
environment in the hospital.
Manage (increase) distance between
sources of EMI and susceptible devices.
Manage (remove) devices that are highly
susceptible to EMI.
Lower power from internal EMI sources
under hospital control (i.e., paging
systems).
Label devices susceptible to EMI.
Educate staff (nurses and doctors) to be
aware of, and to recognize, potential EMI
related problems.
36.202.1 Immunity: ESDAir — Discharges in excess of ±6 Kv may
cause the cuff to deflate and the unit to lock
up. By turning the power switch off, then back
on (manual reset), the unit will be restored to
the user-defined settings and normal
operation.
The Accutracker DX blood pressure monitor
should be kept in the carrying pouch
supplied with each unit.
Care should be taken to minimize the ESD
potential when the Accutracker DX blood
pressure monitor is removed from the
pouch. This includes:
Handling the unit in an ESD-protected
area.
Maintaining humidity levels of 50%
relative humidity or greater.
Discharging ESD potentials on human
hands prior to handling the unit out of the
pouch.
Radio and Telecommunication Terminal Equipment Directive
The ApexPro telemetry system transmitters bear the CE mark CE 0123
indicating conformity with the provisions of the Council Directive 1999/5/
EC of 9 March 1999 concerning R&TTE as tested by MKES BABT
Services GmbH Notified Body TUV (0123).
The product complies with the requirements of standard EN 300 220-1
[ETSI 300 220-1 v1.3.1]: “Electromagnetic Compatibility and Radio
Spectrum Matters (ERM); Short Range Devices (SRD); Part 1: Technical
Characteristics and Test Methods”.
Revision DApexPro Telemetry SystemCE-5
2001989-134
Restrictions
CE Marking Information
The Radio and Telecommunication Terminal Equipment Directive
(R&TTE) states that radio equipment operating in frequency bands for
which the use has not been harmonized across the European Community
have to be identified by an equipment symbol. ApexPro is classified as
Class 2 Equipment and bears the following equipment symbol (also
called the Alert Mark): .
Not all European member states have approved the frequencies within
433. 25 MHz to 434.75 MHz transmitted by the ApexPro telemetry
system for medical telemetry applications.
The following European member states have approved the frequencies
within 433. 25 MHz to 434.75 MHz transmitted by the ApexPro
telemetry system for medical telemetry application:
Austria: Approved for 433.25 MHz to 434.75 MHz; individual
approval from local authorities necessary.
Belgium
Denmark: Individual registration by user necessary in accordance
with “Danish Radio Interface Regulation for radio equipment for
medical telemetry No. 00024.”
Finland
France
Germany
Ireland
Italy: Approved providing compliance with Art. 344 p. to 8 of the
Codice P.T.
Luxembourg
Netherlands
Norway: Approved for 441.750 MHz to 441.975 MHz.
Spain
Sweden
United Kingdom: Approved for 458.975 MHz to 459.100 MHz.
CE-6ApexPro Telemetry SystemRevision D
2001989-134
General Information
CE Marking Information
This manual is an integral part of the product and describes its
intended use. It should always be kept close to 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:
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,
the device is used in accordance with the instructions for use.
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 GE Medical Systems Information Technologies quality
management system complies with the international standards EN
ISO 9001 and EN 46001, and the Council Directive on Medical
Devices 93/42/EEC.
This manual contains the instructions necessary to operate the ApexPro
telemetry system safely and in accordance with its function and intended
use.
This manual addresses the operation of the ApexPro telemetry system at
the CIC Pro. Be sure to read the entire manual before using the
equipment.
Intended Audience
This manual is geared for clinical professionals. Clinical professionals
are expected to have a working knowledge of medical procedures,
practices, and terminology, as required for monitoring of critically ill
patients.
The Basics: About This Manual
This manual assumes that you are familiar with the operating
procedures of the CIC Pro. If you would like more information about
using the CIC Pro, refer to the CIC Pro Clinical Information Center
Operator’s Manual.
This manual also assumes that you are familiar with the operation of a
two-button computer mouse. If you would like more information about
operating the mouse, refer to the CIC Pro Clinical Information Center
Operator’s Manual, or to the documentation supplied with the mouse.
Revision DApexPro Telemetry System1-3
2001989-134
Revision History
The Basics: About This Manual
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.
RevisionDateComments
A25 June 2003Initial release of this document, corresponding to
ApexPro telemetry system software version 3.
B23 October 2003
C21 January 2004
D12 March 2004
Updated to support the ApexPro FH Transceiver
Added additional CE Exceptions for the ApexPro
system.
Added FCC Compliance
Added Industry Canada Compliance
Changed Nurse Graph to Event Marker Graph and
Transmitter Nurse to Event Marker
Added Data Source information
Changed recommended cleaning solutions
Added information regarding time discrepancy
between waveforms
Added information on stopping manual graphs
Made correction to INTFC connector ports 1 and 2
Updated Equipment Symbols
Warning added regarding adjusting System Status
Alarms levels
Added verify lead information to the admit procedure
and electrode placement
Message alarm level added to System Status Alarm
Graph Location Settings information revised
Removed reference to alarm level settings for ARR
SUSPEND, LEADS FAIL, and OFF NETWORK
Changes made to Appendix D for the ApexPro FH
Transceiver
1-4ApexPro Telemetry SystemRevision D
2001989-134
Manual Conventions
This section describes terminology, standards, and other conventions
that are used throughout this manual.
Product References
In this manual:
The ApexPro telemetry system is referred to as the ApexPro system,
or simply the system.
The CIC Pro Clinical Information Center is referred to as the clinical
information center, the CIC Pro or the central station.
The SunTech Medical Systems Accutracker DX noninvasive blood
pressure monitor is referred to as the blood pressure monitor or the
Accutracker.
The PRN 50 Digital Writer is referred to as the digital writer or the
writer.
The Direct Digital Writers are referred to as DDWs or writers.
The laser printer is referred to as the printer.
The Basics: Manual Conventions
Definitions
The following terms are used in this manual:
Buttons — The word “button” is defined in two ways:
1. A button is a labeled gray or red rectangle on the CIC Pro. Clicking
on a button with the mouse pointer opens a tab sheet or performs the
specified action (such as Print). Red buttons are used to view beds in
alarm.
2. A button is a labeled circle, square, or rectangle located on the
ApexPro transmitter, the Apex Oximeter, or the Accutracker blood
pressure monitor. Pressing the button with your finger activates it.
NOTE
The computer mouse used with the CIC Pro also has two buttons.
Refer to the CIC Pro Clinical Information Center Operator’s Manual
for information about using those buttons.
Revision DApexPro Telemetry System1-5
2001989-134
The Basics: Manual Conventions
Messages/Prompts — A message is text that appears on the CIC Pro. It
informs you of conditions occurring that are not necessarily part of
normal operating conditions. Prompts are text messages that appear,
instructing you to perform a specific action.
Multiple patient viewer — The multiple patient viewer is the CIC Pro
display in its normal state. Bed windows for admitted patients are
shown, as well as a menu bar at the bottom of the display.
Screen text — Any text that appears on the CIC Pro display. In this
manual, screen text is shown in italics (for example, ECG, SAVING, etc.).
Single patient viewer — When you click on a patient’s bed window at
the CIC Pro, the display rearranges to accommodate a set of tab sheets
(see definition below) in the bottom portion of the display. This set of tab
sheets is referred to as the single patient viewer because it contains
information specific to one patient.
Tab options — Tab options are the choices and text entry fields
available on a tab sheet. The information presented as tab options may
pertain to a patient’s data, or may be control information (such as alarm
settings) that can be modified to meet the user’s specific needs.
Tab sheets — Tab sheets look like labeled index cards. The menu tab
labels indicate the type of information to be viewed and/or changed on its
tab sheet. Clicking on a tab brings its tab sheet to the front of the “index
card” stack, or to the front of the currently viewed window.
Tabs — Tabs are the labeled section of the tab sheets. Clicking on a tab
brings its tab sheet to the front. Tab and tab sheet are sometimes used
interchangeably.
Illustrations and Names
All illustrations in this manual are provided as examples only. They may
not necessarily reflect your telemetry monitoring setup or data displayed
on your equipment.
In this manual, all names appearing in examples and illustrations are
fictitious. The use of any real person’s name is purely coincidental.
1-6ApexPro Telemetry SystemRevision D
2001989-134
Common Operations
Some operations are used repetitively at the CIC Pro or the ApexPro
telemetry system. Rather than explaining how to perform each operation
every time it appears in this manual, these operations are presented
below. Please familiarize yourself with the proper procedure for each.
“Clicking” the Mouse
The term “click” refers to positioning the mouse pointer on a selection
and pressing the left mouse button one time.
In situations where the right mouse button should be pressed, this is
specifically called out. In all other cases, assume that you should press
the LEFT mouse button.
Pressing the mouse button two times in a row is called double clicking. In
situations where the mouse needs to be double clicked to perform a
function, this is specifically called out. In all other cases, assume that you
only need to click the mouse button ONE time.
The Basics: Common Operations
Radio Buttons
To use a radio button control, click on the white circle (radio button) or
the text next to it. When selected, a black dot is shown in the white circle.
To deselect a radio button control, click again on the label text or in the
white circle. When it is not selected, no black dot is shown.
Radio Buttons —
“Dot” in center
indicates active
selection.
007A
Revision DApexPro Telemetry System1-7
2001989-134
Check Boxes
The Basics: Common Operations
To use check box controls, click on the square or the text next to it. When
selected, a check mark is shown in this square. To deselect a check box
control, click again on the text or in the square. When deselected, no
check mark is shown.
Check Boxes —
indicates active
selection.
078B
Scroll Bars
Use horizontal and vertical scroll bars to move a window’s contents left/
right and up/down. Place the mouse pointer on the appropriate arrow to
move the scroll bar, or click and hold the mouse button down while
dragging the scroll bar until the desired information is displayed.
Vertical
Scroll
Bar
Horizontal
Scroll Bar
359A
1-8ApexPro Telemetry SystemRevision D
2001989-134
Popup Lists
The Basics: Common Operations
Clicking in a text field may produce a down arrow button on the right
side of the field. This arrow button is used to open a popup list. A popup
list is a list of options available for that particular field. Use the mouse to
click on the arrow button, which opens the popup list.
Arrow Button —
indicates there is a
popup list.
Popup List
332A
Once the popup list is open, use the mouse to click on an option. This
selects the option and closes the popup list.
NOTE
If you click on the right side of a field, the down arrow button and the
popup list of selections may appear simultaneously.
Revision DApexPro Telemetry System1-9
2001989-134
The Basics: Unit Defaults Worksheet
Unit Defaults Worksheet
This worksheet has been provided as an optional reference tool to record
your care unit’s default settings. Fill out the information and keep it in a
prominent place to refer to your setup. For your convenience, the factory
default settings appears dimmed. Fill in only those settings that differ
from the factory default ones.
NOTE
Before you fill it out, you may want to make additional copies of the
worksheet for future use.
Date:Unit:
Telemetry Alarm Control Defaults
Parameter Limits and Alarm LevelsLowHighLevelArrhythmia Alarm LevelsLevels
HRbpm50150WarningAsystoleCrisis
ST-Imm-2.02.0WarningVFIB/VTACCrisis
ST-IImm-2.02.0WarningV TachCrisis
ST-IIImm-2.02.0WarningVT > 2Crisis
ST-Vmm-2.02.0WarningV BradyCrisis
ST-V2mm-2.02.0WarningAcc VentAdvisory
ST-V3mm-2.02.0WarningPauseAdvisory
ST-V4mm-2.02.0WarningTachyAdvisory
ST-V5mm-2.02.0WarningBradyAdvisory
ST-V6mm-2.02.0WarningR on TMessage
ST-AVRmm-2.02.0WarningCoupletMessage
ST-AVLmm-2.02.0WarningBigeminyMessage
ST-AVFmm-2.02.0WarningTrigeminyMessage
NBP-SmmHg80200WarningPVCMessage
NBP-DmmHg20120WarningIrregularMessage
NBP-MmmHg40140WarningAtrial FibMessage
SPO2%90105Warning
SPO2-Rbpm50150WarningSystem Alarm LevelsLevels
RRbreaths/min530WarningChange BatterySys Warning
RR-APNEAseconds30WarningOff NetworkSys Warning
PVC#/min6AdvisoryArr SuspendSys Warning
Leads FailSys Warning
Probe OffSys Warning
1-10ApexPro Telemetry SystemRevision D
2001989-134
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