GE Medical Systems Information Technologies 2014748-002 Medical Telemetry Transmitter User Manual

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Document ID	881640
Application ID	maTnhnqxAd0JjwUy/T2xFQ==
Document Description	Manual Draft1 Part 4
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Document Type	User Manual
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Filesize	12.75kB (159414 bits)
Date Submitted	2007-12-19 00:00:00
Date Available	2007-12-19 00:00:00
Creation Date	2007-12-19 14:19:49
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Technical specifications . . . . . . . . . . . . . . . . . . . . . . E-1
ApexPro and ApexPro CH transmitters. . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Alarms and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Device specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
af
ApexPro telemetry server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Display specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Power specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Dr
ApexPro receiver system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Performance specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Network requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
viii
ApexPro™
2001989-301A- draft 1
Introduction
Dr
af
2001989-301A- draft 1
ApexPro™
1-1
Introduction
Manual information
Purpose
This manual contains the instructions necessary to operate the ApexPro telemetry
system safely and in accordance with its function and intended use.
It also contains limited instructions necessary to operate the telemetry system when
used with the CIC Pro Clinical Information Center. For more information, refer to
Related documents on page 1-2.
Intended audience
This manual is intended 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.
Related documents
af
This manual is intended to be used in conjunction with the CIC Pro Clinical
Information Center Operator’s Manual (PN 2026421-001) and the CIC Pro Clinical
Information Center Bedrock Hardware Platform Service Manual (PN 2026421-002).
This manual assumes that you are familiar with the operating procedures of the CIC
Pro Clinical Information Center. It uses the CIC Pro software version 5 (or later) user
interface for procedures, navigation and illustration purposes.
Dr
If your system uses an earlier CIC Pro software version, you may notice minor
discrepancies between what you see on the equipment and the information presented
in this manual. Refer to the documentation provided with your system for the most
accurate operator’s and service instructions.
Conventions used
Equipment terms
This manual uses the following terms to simplify common equipment names.
Term
1-2
Description
ATS
Refers to the ApexPro Telemetry Server.
CIC Pro center
Refers to the CIC Pro Clinical Information Center.
Monitor
Refers to a bedside monitor, transport monitor, blood pressure
monitor, or a wireless monitor on the Unity Network.
Printer
Refers generically to a direct digital writer or a laser printer.
Server
Refers to the ApexPro Telemetry Server (ATS) or a CIC Pro
center with a BCM or Nightshade server.
ApexPro™
2001989-301A- draft 1
Introduction
Term
Description
Transmitter
Refers to the CARESCAPE Telemetry T14 transmitter.
Writer
Refers to the PRN 50-M digital writer.
Text styles
This manual uses the following text styles to identify hardware terms, software terms
and the correct way to enter data.
Style
Indicates hardware items, such as keys, labels or connectors.
Bold and italicized
Indicates software items, such as menus, menu options or
screen text.
Italics
Emphasizes a word.
Indicates menu options or control settings to select
consecutively.
Indicates keyboard keys to select simultaneously.
Bold
af
Illustrations and names
Definition
In this manual, all illustrations are provided as examples only. They may not
necessarily reflect your monitoring setup or data viewed on your monitoring device.
Dr
All names appearing in examples and illustrations are fictitious. The use of any real
person’s name is purely coincidental.
Ordering manuals
A paper copy of this manual will be provided upon request. Contact your local GE
representative and request the part number on the first page of the manual.
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
2001989-301A- draft 1
Comments
Initial release.
ApexPro™
1-3
Introduction
Equipment information
Intended use of this equipment
The ApexPro telemetry system is intended for use under the direct supervision of a
licensed healthcare practitioner. The system is designed to acquire and monitor
physiological data for ambulating patients within a defined coverage area. The system
processes this physiological data to detect various ECG arrhythmia events and select
physiological parameter limit violations.
The ApexPro telemetry system is intended to be installed in the hospital or clinical
environment in order to provide clinicians with patient physiological data, while
allowing for patient mobility. These systems are typically deployed in sub acute care
areas in hospitals or clinical sites where patient mobility can enhance the
effectiveness of the medical procedures administered.
af
Safety statements
The physiological parameters monitored include ECG, non-invasive blood pressure
and SpO2. The ApexPro telemetry system is intended to provide ECG data via
Ethernet to the computer platform for processing. The ApexPro is also intended to
provide physiologic data over the Unity network to clinical information systems for
display.
The safety statements presented in this chapter refer to the equipment in general and,
in most cases, apply to all aspects of the device. There are additional safety statements
in other chapters which are specific to that chapter content.
Dangers
Dr
The order in which safety statements are presented in no way implies the order of
importance.
Danger statements identify an imminent hazard which, if not avoided, will result in
death or serious injury. No danger statements apply to this system.
Warnings
Warning statements identify a potential hazard or unsafe practice which, if not
avoided, could result in death or serious injury.
The following warning statements apply to this system.
WARNING
Do not monitor patients with a 3-leadwire set when reliable pacer
detection is required. Pacer pulse detection can be erratic when only
a single vector is monitored. Always use a 5- or 6-leadwire set when
reliable pacer detection is required.
1-4
ApexPro™
2001989-301A- draft 1
Introduction
WARNING
ACCESSORIES (SUPPLIES) — To ensure patient safety, use only
parts and accessories manufactured or recommended by GE.
Parts and accessories used must meet the requirements of the
applicable IEC 60601 series safety standards and essential
performance standards, and/or the system configuration must meet
the requirements of the IEC 60601-1-1 medical electrical systems
standard.
WARNING
ACCESSORIES (EQUIPMENT) — The use of accessory
equipment not complying with the equivalent safety requirements of
this equipment may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
use of the accessory in the patient vicinity; and
„
evidence that the safety certification of the accessory has been
performed in accordance to the appropriate IEC 60601-1 and/or
IEC 60601-1-1 harmonized national standard.
„
Dr
af
WARNING
ACCIDENTAL SPILLS — To avoid electric shock or device
malfunction, liquids must not be allowed to enter the device. If
liquids have entered a device, take it out of service and have it
checked by a service technician before it is used again.
WARNING
ACCURACY — If the accuracy of any value displayed on the
monitor, central station, or printed on a graph strip is questionable,
determine the patient's vital signs by alternative means. Verify that
all equipment is working correctly.
WARNING
ADJUSTING SYSTEM ALARM LEVELS — The Leads Fail
alarm indicates that one or more electrodes are not connected to the
patient and, as a result, there is loss of all waveforms and arrhythmia
analysis. The ARR SUSPEND alarm indicates that arrhythmia
conditions are not being detected and therefore alarms associated
with arrhythmias will not occur. The Leads Fail and ARR
SUSPEND alarms should be adjusted to a lower priority level only
by experienced qualified personnel and with great caution.
Adjusting these alarms to a lower priority level may result in
reduced awareness of conditions that indicate the loss of patient
monitoring.
2001989-301A- draft 1
ApexPro™
1-5
Introduction
WARNING
ALARMS — Do not rely exclusively on the audible alarm system
for patient monitoring. Adjustment of Alarm Volume to a low level
or off during patient monitoring may result in a hazard to the patient.
Remember that the most reliable method of patient monitoring
combines close personal surveillance with correct operation of
monitoring equipment.
After connecting the monitor to the central station, nurse-call
system, and/or network, verify the function of the alarm system.
The functions of the alarm system for monitoring of the patient must
be verified at regular intervals.
Do not rely exclusively on the Alarm Pause Breakthrough feature
for alarm notification during an alarm pause. This may result in a
hazard to the patient. Only crisis alarms break through an alarm
pause.
af
WARNING
BEFORE INSTALLATION — Compatibility is critical to safe and
effective use of this device. Please contact your local sales or service
representative prior to installation to verify equipment compatibility.
Dr
WARNING
BEFORE USE — Before putting the system into operation visually
inspect all connecting cables for signs of damage. Damaged cables
and connectors must be replaced immediately.
Before using the system, the operator must verify that it is in correct
working order and operating condition.
Periodically, and whenever the integrity of the product is in doubt,
test all functions.
WARNING
CABLES — Route all cables away from patient's throat to avoid
possible strangulation.
1-6
ApexPro™
2001989-301A- draft 1
Introduction
WARNING
CONDUCTIVE CONNECTIONS — Extreme care must be
exercised when applying medical electrical equipment. Many parts
of the human/machine circuit are conductive, such as the patient,
connectors, electrodes, transducers. It is very important that these
conductive parts do not come into contact with other grounded,
conductive parts when connected to the isolated patient input of the
device. Such contact would bridge the patient's isolation and cancel
the protection provided by the isolated input. In particular, there
must be no contact of the neutral electrode and ground.
WARNING
DEFIBRILLATION — Do not come into contact with patients
during defibrillation. Otherwise serious injury or death could result.
af
WARNING
DISCONNECTION FROM MAINS — When disconnecting the
system from the power line, remove the plug from the wall outlet
first. Then you may disconnect the power cord from the device. If
you do not observe this sequence, there is a risk of coming into
contact with line voltage by inserting metal objects, such as the pins
of leadwires, into the sockets of the power cord by mistake.
Dr
WARNING
DISPOSAL — Dispose of the packaging material, observing the
applicable waste control regulations and keeping it out of children's
reach.
WARNING
DUST COVERS — If the dust covers for the interface connectors
become detached from the transmitter, they may pose a choking
hazard for pediatric patients. Inspect the dust covers before each use
to verify that they are securely attached. If the dust covers become
detached and cannot be reinserted into their retaining slot, do not use
them on the transmitter, and keep them out of pediatric patients’
reach.
WARNING
ELECTRODES — Whenever patient defibrillation is a possibility,
use non-polarizing (silver/silver chloride construction) electrodes
for ECG monitoring. Polarizing electrodes (stainless steel or silver
constructed) may cause the electrodes to retain a residual charge
after defibrillation. A residual charge will block acquisition of the
ECG signal.
2001989-301A- draft 1
ApexPro™
1-7
Introduction
WARNING
ELECTROMAGNETIC INTERFERENCE — Operation of
transmitters outside the designated WMTS frequency band is at
increased risk for electromagnetic interference. WMTS is protected
in the U.S. only. This interference could lead to lapses in patient
monitoring and missed alarm events, putting the patient at risk and
compromising patient safety.
WARNING
EMC— Magnetic and electrical fields are capable of interfering
with the proper performance of the device. For this reason make sure
that all external devices operated in the vicinity of the monitoring
system comply with the relevant EMC requirements. X-ray
equipment or MRI devices are a possible source of interference as
they may emit higher levels of electromagnetic radiation.
af
Changes or modifications to this device/system not expressly
approved by GE may cause 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:
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.
Dr
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.
The use of accessories, transducers and cables other than those
specified may result in increased emissions or decreased immunity
performance of the device/system.
This device/system is suitable for use in all establishments other
than domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes. Mains power should be that of a typical commercial or
hospital environment. Device is compliant to Class A.
WARNING
EXPLOSION HAZARD — Do not use this equipment in the
presence of flammable anesthetics, vapors or liquids.
1-8
ApexPro™
2001989-301A- draft 1
Introduction
WARNING
IMPROPER TRANSMITTER/LEADWIRE APPLICATION —
Applying a transmitter and/or leadwire that is not thoroughly dry to
a patient can result in an electrically conductive path being
established and a Leads Fail alarm not being provided if leadwires
come off the patient.
WARNING
INCORRECT ALGORITHMS, ARRHYTHMIA PROCESSING
AND CALCULATIONS BASED ON PATIENT AGE — After
manually updating or automatically retrieving patient demographic
information from a network database, always confirm that the
entered patient’s date of birth matches the patient’s actual date of
birth. Otherwise the appropriate age-related algorithms, arrhythmia
detection, and calculations will not be applied.
Dr
af
WARNING
INTERFACING OTHER EQUIPMENT — Devices may only be
interconnected with each other or to parts of the system when it has
been determined by qualified biomedical engineering personnel that
there is no danger to the patient, the operator, or the environment as
a result. In those instances where there is any element of doubt
concerning the safety of connected devices, the user must contact
the manufacturers concerned (or other informed experts) for proper
use. In all cases, safe and proper operation should be verified with
the applicable manufacturer's instructions for use, and system
standards IEC 60601-1-1/EN 60601-1-1 must be complied with.
WARNING
LEAKAGE CURRENT TEST — When interfacing with other
equipment, a test for leakage current must be performed by qualified
biomedical engineering personnel before using with patients.
WARNING
LOSS OF DATA — Should the monitor at any time temporarily lose
patient data, the potential exists that active monitoring is not being
done. Close patient observation or alternate monitoring devices
should be used until monitor function is restored.
If the monitor does not automatically resume operation within 60
seconds, power cycle the monitor using the power on/off switch.
Once monitoring is restored, you should verify correct monitoring
state and alarm function.
2001989-301A- draft 1
ApexPro™
1-9
Introduction
WARNING
LOSS OF DATA —Caregivers and telemetry patients should be
made aware of antenna coverage areas. Movement outside of the
coverage area may result in loss of patient monitoring.
WARNING
NETWORK INTEGRITY — The ApexPro server resides on the
Unity network. It is possible that inadvertent or malicious network
activity could adversely affect patient monitoring. The integrity of
the Unity network is the responsibility of the hospital.
WARNING
OPERATOR — Medical technical equipment such as this monitor/
monitoring system must only be used by persons who have received
adequate training in the use of such equipment and who are capable
of applying it properly.
af
WARNING
POWER SUPPLY — All devices must be connected to a properly
installed power outlet with protective earth contacts only. If the
installation does not provide for a protective earth conductor,
disconnect the device from the power line and operate it on battery
power, if possible.
Dr
All devices of a system must be connected to the same power supply
circuit. Devices which are not connected to the same circuit must be
electrically isolated when operated (electrically isolated EIA232
interface).
WARNING
PROTECTED LEADWIRES — Only use protected leadwires and
patient cables with this device. The use of unprotected leadwires and
patient cables creates the potential for making an electrical
connection to ground or to a high voltage power source which can
cause serious injury or death to the patient.
Unprotected Leadwire
Protected Leadwire
322C
1-10
ApexPro™
2001989-301A- draft 1
Introduction
WARNING
RATE METERS — Keep pacemaker patients under close
observation. Rate meters may continue to count the pacemaker rate
during cardiac arrest and some arrhythmias. Therefore, do not rely
entirely on rate meter alarms.
WARNING
SINGLE PATIENT USE —This transmitter is designed for use on
one patient at a time. Using this equipment to monitor different
parameters on different patients at the same time compromises the
accuracy of data acquired.
af
WARNING
SITE REQUIREMENTS — For safety reasons, all connectors for
patient cables and sensor leads are designed to prevent inadvertent
disconnection, should someone pull on them. Do not route cables in
a way that they may present a stumbling hazard. For devices
installed above the patient, adequate precautions must be taken to
prevent them from dropping on the patient.
Cautions
Dr
Caution statements identify a potential hazard or unsafe practice which, if not
avoided, could result in minor personal injury or product/property damage.
The following caution statements apply to this system.
CAUTION
DEFIBRILLATOR PRECAUTIONS — Patient signal inputs
labeled with the CF and BF symbols with paddles are protected
against damage resulting from defibrillation voltages. To ensure
proper defibrillator protection, use only the recommended cables
and leadwires.
Proper placement of defibrillator paddles in relation to the electrodes
is required to ensure successful defibrillation.
CAUTION
DISPOSABLES — Disposable devices are intended for single use
only. They should not be reused as performance could degrade or
contamination could occur.
2001989-301A- draft 1
ApexPro™
1-11
Introduction
CAUTION
DISPOSAL — At the end of its service life, the product described in
this manual, as well as its accessories, must be disposed of in
compliance with the guidelines regulating the disposal of such
products. If you have questions concerning disposal of the product,
please contact GE or its representatives.
CAUTION
ELECTROCAUTERY PRECAUTIONS — To prevent unwanted
skin burns, apply electrocautery electrodes as far as possible from all
other electrodes, a distance of at least 15 cm/6 in. is recommended.
CAUTION
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.
Dr
af
CAUTION
MAINTENANCE — Regular preventive maintenance should be
carried out annually. You are responsible for any requirements
specific to your country.
CAUTION
MPSO — Do not use a multiple portable socket outlet (MPSO) for a
system because it could result in unacceptable enclosure leakage
currents.
CAUTION
NEGLIGENCE — GE does not assume responsibility for damage to
the equipment caused by improperly vented cabinets, improper or
faulty power, or insufficient wall strength to support equipment
mounted on such walls.
1-12
ApexPro™
2001989-301A- draft 1

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