GE Corometrics 250cx Series, Руководство оператора

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1-6 250cx Series Maternal/Fetal Monitor Revision C
2036946-001
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).