All equipment sold by GE Medical Systems Information Technologies, is fully guaranteed as to
materials and workmanship for a period of 1 year. GE Medical Systems Information Technologies reserves the right to perform guarantee service operations in its own factory, at
an authorized repair station, or in the customer’s installation.
Our obligation under this guarantee is limited to repairing, or, at our option, replacing any
defective parts of our equipment, except fuses or batteries, without charge, if such defects
occur in normal service.
Claims for damage in shipment should be filed promptly with the transportation company. All
correspondence covering the instrument should specify the model and serial numbers.
GE MEDICAL SYSTEMS Information Technologies
A GE Healthcare Company
GE Medical Systems Information Technologies will make available on request such circuit diagrams, component
diagrams, component parts lists, descriptions, calibration instructions, or other information which will assist the users
or appropriately qualified technical personnel to repair those parts of the equipment which are classified by GE
Medical Systems Information Technologies as repairable. Refer to the 250/250cx Series Service Manual for further
information.
NOTE: In addition to software version 4.50, the information in this manual also applies to previous software
revisions of Corometrics 250cx Series Monitor. There are no user-apparent differences among these software
versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.
NOTE: For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical
Systems Information Technologies
Ohmeda Oximetry and other trademarks (OxyTip+®, PIr™, TruSat™, TruSignal™, TruTrak+®, SuperSTAT™) are the
property of GE Medical Systems Information Technologies, a division of General Electric Corporation. All other product
and company names are the property of their respective owners.
MASIMO SET
®
is a trademark of Masimo Corporation. Possession or purchase of this device does not convey any
express or implied license to use the device with replacement parts which would, alone, or in combination with this
device, fall within the scope of one or more of the patents relating to the device.
NELLCOR
TAT-5000™, Exergen
®
, OxiMax®, C-LOCK® and SatSeconds™ are trademarks of Nellcor Puritan Bennett.
®
and TemporalScanner™ are trademarks of Exergen Corporation.
CAUTION: In the United States of America, Federal Law restricts this device to sale
by or on the order of a physician.
A GE brand Corometrics 250cx Series Monitor bears CE mark CE-0086
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 device is manufactured in India; the CE mark is applied under the
authority of Notified Body BSI (0086).
The country of manufacture and appropriate Notified Body can be found
on the equipment labeling.
The product complies with the requirements of standard EN 60601-1-2
“Electromagnetic Compatibility—Medical Electrical Equipment” and
standard EN 60601-1 “General Requirements for Safety.”
0086
Components of the Certified Systems
The IEC electromagnetic compatibility (EN) standards require individual
equipment (components and accessories) to be configured as a system
for evaluation. For systems that include a number of different
equipments that perform a number of functions, one of each type of
equipment shall be included in the evaluation.
The equipment listed below is representative of all possible
combinations. For individual equipment certification, refer to the
appropriate declarations of conformity.
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.
If the monitor is cold to the touch or below ambient t emperature, allow it to stabilize
before use.
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE Medical Systems Information Technologies. Parts and
accessories used shall meet the requirements of EN60601-1-1.
Disposable devices are intended for single use only. They should not be reused.
Test all functions periodically and whenever the integrity of the monitor is in doubt.
Refer to the “Maternal/Fetal Monitoring, Clinical Applications Manual” for
information concerning the limitations of internal and external feta l heart rate
monitoring techniques.
Responsibility of the Manufacturer
GE Medical Systems Information Technologies is responsible for the effects on
safety, reliability, and performance 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
appropriate regulations; and
the monitor is used in accordance with the instructions of use.
Responsibility of the User
This device is intended for use by clinical professionals who are expected to know
the medical procedures, practices, and terminology required to monitor obstetrical
patients. This manual documents all possible parameters available in the 250cx
Series monitor. It is the responsibility of each hospital to ensure that the Labor and
Delivery staff is trained in all aspects of the selected model.
The 250cx Series monitor is only one clinical indicator of fetal status during labor.
The monitor is designed to assist the perinatal staff in assessing the status of a
patient. The monitor does not replace observation and evaluation of the mother and
fetus at regular intervals by a qualified care provider, who will make diagnoses and
decide on treatments or interventions. Visual assessment of the monitor display and
strip chart must be combined with knowledge of patient history and risk factors to
properly care for the mother and fetus.
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Safety: Definitions of Terminology
Definitions of Terminology
Six types of special notices are used throughout this manual. They are: Danger,
Warning, Caution, Contraindication, Important, and Note. The warnings and
cautions in this Safety section relate to the equipment in general and apply to all
aspects of the monitor. Be sure to read the other chapters because there are
additional warnings and cautions which relate to specific features of the monitor.
When grouped, warnings and cautions are listed alphabetically and do not imply any
order of importance.
DangerA DANGER notice indicates an imminently
WarningA WARNING indicates a potentially hazardous
Definitions of Terminology
hazardous situation which, if not avoided, will result
in death or serious injury.
situation which, if not avoided, could result in death
or serious injury.
CautionA CAUTION indicates a potentially hazardous
situation which, if not avoided, may result in minor
or moderate injury. Cautions are also used to avoid
damage to equipment.
ContraindicationA CONTRAINDICATION describes any special
symptom or circumstance that renders the use of a
remedy or the carrying out of a procedure
inadvisable, usually because of a risk.
ImportantAn IMPORTANT notice indicates an emphasized
note. It is something you should be particularly
aware of; something not readily apparent.
NoteA NOTE indicates a particular point of information;
something on which to focus your attention.
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Safety: Monitor Contraindications, Warnings, and Precautions
Monitor Contraindications, Warnings, and
Precautions
Warnings
WARNINGS
ACCIDENTAL SPILLS—In the event that fluids are accidentally
spilled onto the monitor, remove the monitor from operation and
inspect for damage.
APPLICATION—This monitor is not designed for direct cardiac
connection.
CONDUCTIVE CONNECTIONS—Avoid making any
conductive connections to applied parts (patient connection)
which are likely to degrade safety.
CONDUCTIVE PARTS—Ensure that the conductive parts of the
lead electrodes and associated connectors do not contact other
conductive parts including earth.
CONNECTIONS—The correct way to connect a patient to the
monitor is to plug the electrode leads into the patient cable which
in turn connects to the monitor. The monitor is connected to the
wall socket by the power cord. Do not plug the electrode leads
into the power cord, a wall socket, or an extension cord.
DEFIBRILLATION—During defibrillation, all personnel must avoid
contact with the patient and monitor to avoid a dangerous shock
hazard. In addition, proper placement of the paddles in relation to the
electrodes is required to minimize harm to the patient.
DEFIBRILLATION PROTECTION—When used with the GE
Medical Systems Information Technologies-recommended
accessories, the monitor is protected against the effects of
defibrillator discharge. If monitoring is disrupted by the
defibrillation, the monitor will recover.
ELECTRICAL SHOCK—To reduce the risk of electrical shock,
do not remove monitor cover. Refer servicing to qualified
personnel.
ELECTROMAGNETIC INTERFERENCE—Be aware that strong
electromagnetic fields may interfere with monitor operation.
Interference prevents the clear reception of signals by the monitor.
If the hospital is close to a strong transmitter such as TV , AM or FM
radio, police or fire stations, a HAM radio operator, an airport, or
cellular phone, their signals could be picked up as monitor signals.
If you feel interference is affecting the monitor, contact your
Service Representative to check the monitor in your environment.
Refer to
information.
“Electromagnetic Interference”
on page 1-9 for additional
Revision C250cx Series Maternal/Fetal Monitor1-5
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Safety: Monitor Contraindications, Warnings, and Precautions
WARNINGS
ELECTROSURGERY—The monitor is not designed for use with
high-frequency surgical devices. In addition, measurements may
be affected in the presence of strong electromagnetic sources such
as electrosurgery equipment.
EQUIPMENT USE—The use of this equipment is restricted to
one patient at a time.
EXPLOSION HAZARD—Do not use this equipment in the
presence of flammable anesthetics or inside an oxygen tent.
GROUNDING—Do not defeat the three-wire grounding feature
of the power cord by means of adaptors, plug modifications, or
other methods. A dangerous shock hazard to both patient and
operator may result.
INOPERABLE MECG—The MECG trace is not visible during a
MECG LEADS OFF condition or an overload (saturation) of the front-
end amplifier during differential input voltage of more than
±
300mV.
INSTRUCTIONS—For continued and safe use of this equipment,
it is necessary to follow all listed instructions. However, the
instructions provided in this manual in no way supersede
established medical procedures concerning patient care. The
monitor does not replace observation and evaluation of the
patient, at regular intervals, by a qualified care provider who will
make diagnoses and decide on treatments and interventions.
INTERFACING OTHER EQUIPMENT—Monitoring equipment
must be interfaced with other types of medical equipment by
qualified biomedical engineering personnel. Be certain to consult
manufacturers’ specifications to maintain safe operation.
LEAKAGE CURRENT TEST—The interconnection of auxiliary
equipment with this device may increase the total leakage current.
When interfacing with other equipment, a test for leakage current
must be performed by qualified biomedical engineering personnel
before using with patients. Serious injury or death could result if
the leakage current exceeds applicable standards. 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 with the appropriate EN60601.1 and/or
EN60601.1.1 harmonized national standard.
LINE ISOLATION MONITOR TRANSIENTS—Line isolation
monitor transients may resemble actual cardiac waveforms, and
thus cause incorrect heart rate determinations and alarm activation
(or inhibition).
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Safety: Monitor Contraindications, Warnings, and Precautions
WARNINGS
MRI USE—Do not use the electrodes during MRI scanning;
conducted current could potentially cause burns.
PATIENT CABLES AND LEADWIRES—Do not use patient
cables and electrode leads that permit direct connection to
electrical sources. Use only “safety” cables and leadwires. Use of
non-safety patient cables and lead wires creates risk of
inappropriate electrical connection which may cause patient shock
or death.
PACEMAKER PATIENTS—Rate meters may continue to count
the pacemaker rate during occurrences of cardiac arrest or some
arrhythmias. Do not rely entirely upon rate meter alarms. Keep
pacemaker patients under close surveillance. Refer to Chapter 16,
“Troubleshooting” for disclosure of the pacemaker pulse rejection
capability of the 250cx Series Monitor.
RF INTERF ACE—Known RF sources, such as cell phones, radio
or TV stations, and two-way radios, may cause unexpected or
adverse operation of this device.
SIMULTANEOUS DEVICES—Do not simultaneously connect
more than one device that uses electrodes to detect ECG and/or
respiration to the same patient. Use of more than one device in this
manner may cause improper operation of one or more of the devices.
STRANGULATION—Make sure all patient cables, leadwires,
and tubing are positioned away from the patient’s head to
minimize the risk of accidental strangulation.
WATER BIRTHS—Do not use the monitor to directly monitor
patients during water births, in whirlpool or submersion water
baths, during showers, or in any other situation where the mother is
immersed in water. Doing so may result in electrical shock hazard.
EXTERNAL VGA CONNECTIONS—Connect only to GE
recommended display. ONLY remove cover plate if external
display is used.
TELEMETRY CONNECTIONS—Connect only to GE
recommended telemetry systems. Contact your GE service
representative for more information.
Revision C250cx Series Maternal/Fetal Monitor1-7
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Safety: Monitor Contraindications, Warnings, and Precautions
WARNINGS
COLOR DISPLAY—Certain colors may have limited visibility at a
distance. Color-blind individuals may experience this more often.
Cautions
EXERGEN
be field serviced. Do
This assembly must be returned to the factory for any repairs. This
assembly, as shipped, is important to patient safety.
DISPOSAL—This product consists of devices that may contain
mercury, which must be recycled or disposed of in accordance with
local, state, or country laws. (Within this system, the backlight
lamps in the monitor display contain mercury.)
CAUTIONS
STATIC ELECTRICITY—This assembly is extremely static
sensitive and should be handled using electrostatic discharge
precautions.
ANNUAL SERVICING—For continued safety and performance
of the monitor, it is recommended that the calibration, accuracy,
and electrical safety of the monitor be verified on an annual basis
by a GE Medical Systems Information Technologies Service
Representative.
®
TAT-5000™ —Cable assembly 2036641-001 cannot
NOT
attempt any repairs to this assembly.
DAILY TESTING—It is essential that the monitor and accessories
be inspected every day. It is recommended practice to initiate the
monitor’s self-test feature at the beginning of each monitoring
session; follow the instructions in Chapter 4,
ENVIRONMENT—The performance of the monitor has not been
tested in certain areas, such as x-ray and imaging suites. The
monitor is not recommended for use in these environments.
EQUIPMENT CONFIGURATION—The equipment or system
should not be used adjacent to, or stacked with, other equipment.
If adjacent or stacked use is necessary, the equipment or system
should be tested to verify normal operation in the configuration in
which it is being used.
PERFORMANCE—Report all problems experienced with the
monitor. If the monitor is not working properly, contact your
Service Representative for service. The monitor should not be used
if it is not working properly.
“Setup Procedures”
.
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Safety: Monitor Contraindications, Warnings, and Precautions
Electromagnetic Interference
This device has been tested and found to comply with the Medical Electrical
Equipment-General Requirements for Safety-Collateral Standard: Electromagnetic
Compatibility, EN60601-1-2:2001, Medical Device Directive 93/42/EEC. These
limits are designed to provide reasonable protection against harmful interference in
a typical medical installation.
However, because of the proliferation of radio-frequency transmitting equipment
and other sources of electrical noise in the health-care and home environments (e.g.
cellular phones, mobile two-way radios, electrical appliances), it is possible that
high levels of such interference due to proximity or strength of a source, may result
in disruption of performance of this device.
Refer to the Electromagnetic Immunity inf ormation in this product’s service manual
for EN 60601-1-2 (2001) compliance information and safety information for this
product.
This equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with these instructions, may cause harmful
interference with other devices in the vicinity. Disruption or interference may be
evidenced by erratic readings, cessation of operation, or incorrect functioning. If this
occurs, the use site should be surveyed to determine the source of this disruption,
and actions should be taken to eliminate the source.
The user is encouraged to try to correct the interference by one or more of the
following measures:
Turn equipment in the vicinity off and on to isolate the offending
equipment.
Reorient or relocate the other receiving device.
Increase the separation between the interfering equipment and this
equipment.
If assistance is required, contact your GE Medical Systems Service
Representative.
Revision C250cx Series Maternal/Fetal Monitor1-9
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Equipment Symbols
The following is a list of symbols used on products manufactured by GE Medical
Systems Information Technologies. Some symbols may not appear on your unit.
Safety: Equipment Symbols
Equipment Symbols
ATTENTION: Consult accompanying documents.
WASTE OF ELECTRICAL AND ELECTRONIC
EQUIPMENT (WEEE): This symbol indicates that
the waste of electrical and electronic equipment
must not be disposed as unsorted municipal waste
and must be collected separately. Please contact
an authorized representative of the manufacturer
for information concerning the decommissioning of
your equipment.
TYPE B EQUIPMENT: Type B equipment is
suitable for intentional external and internal
application to the patient, excluding direct cardiac
application.
TYPE BF EQUIPMENT:
suitable for intentional external and internal
application to the patient, excluding direct cardiac
application. Type BF equipment has an F-type
applied part.
DEFIBRILLATOR-PROOF TYPE BF EQUIPMENT:
Type BF equipment is suitable for intentional
external and internal application to the patient,
excluding direct cardiac application. Type BF
equipment is type B equipment with an F-type
isolated (floating) part. The paddles indicate the
equipment is defibrillator proof.
TYPE CF EQUIPMENT: Type CF equipment is
suitable for intentional external and internal
application to the patient including direct cardiac
application. Type CF equipment is F-type applied
part that provides a higher degree of protection
against electric shock than that provided by Type
BF applied parts.
Type BF equipment is
ALTERNATING CURRENT (AC).
EQUIPOTENTIALITY.
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Safety: Equipment Symbols
OPOWER OFF: disconnection from the mains.
IPOWER ON: connection to the mains.
Equipment Symbols
VGA connection.
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Safety: Equipment Symbols
1-12250cx Series Maternal/Fetal MonitorRevision C
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2Introduction
Revision C250cx Series Maternal/Fetal Monitor2-1
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For your notes
Introduction:
2-2250cx Series Maternal/Fetal MonitorRevision C
2036946-001
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