Revision D 170 Series Monitor 1-5
2003023-001
Safety: Monitor Safety Information
operator may result.
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 other equipment, a test of 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 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).
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.
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