Fukuda 8000 Series, Maintenance Manual

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xi
Safety Precautions for Using the Equipment
 If the safety of the patient cannot be ensured, do not suspend the alarm or decrease the alarm volume.

The oxygenator mode is intended to prevent alarms during cardiopulmonary bypass surgery. Pay special
attention when using this mode as the alarm generation will not be the same as to the standard monitoring mode.

If the "Alarm Setting" under the Oxygenator Mode Setup is set to [All OFF], all vital alarm will not generate
regardless of the alarm setting of each parameter. Also, if [Sel. Parameter] is set, vital alarm for unselected
parameter will not generate. Pay attention to not miss any significant change of the patient's vital sign as the
alarms will not be generated during the Oxygenator Mode.
 Once the cardiopulmonary bypass is finished, make sure to cancel the Oxygenator Mode and return to the
standard monitoring mode.
Warnings about the SpO
2
Monitoring (HS-8312M or HG-810)
 Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect
certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based
arrhythmia analysis.
 A Pulse CO-Oximeter should be considered an early warning device. As a trend towards patient hypoxemia is
indicated, blood samples should be analyzed by laboratory instruments to completely understand the patient's
condition.
 For measurements of high or low SpHb readings, blood samples should be analyzed by laboratory instruments
to completely understand the patient's condition.
 SpO
2
is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal
levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A pulse oximeter can not measure
elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO
2
measurement.
 For increased COHb: COHb levels above normal tend to increase the level of SpO
2
. The level of increase is
approximately equal to the amount of COHb that is present.
NOTE
 High levels of COHb may occur with a seemingly normal SpO
2
. When elevated levels of
COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be
performed.
 For increased MetHb: the SpO
2
may be decreased by levels of MetHb of up to approximately 10% to 15%.
At higher levels of MetHb, the SpO
2
may tend to read in the low to mid 80s. When elevated levels of MetHb
are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed.
 Interfering Substances: Dyes, or any substance containing dyes, that change usual blood pigmentation may
cause erroneous readings.
 Hemoglobin synthesis disorders may cause erroneous SpHb readings.
 Elevated levels of Total Bilirubin may lead to inaccurate SpO
2
, SpMet, SpCO, SpHb measurements.

Motion artifact may lead to inaccurate SpMet, SpCO, SpHb measurements.
 Severe anemia may cause erroneous SpO
2
readings.

Very low arterial Oxygen Saturation (SpO
2
) levels may cause inaccurate SpCO and SpMet measurements.
 With very low perfusion at the monitored site, the readings may read lower than core arterial oxygen saturation.
 Do not use tape to secure the sensor to the site; this can restrict blood flow and cause inaccurate readings. Use
of additional tape can cause skin damage or damage the sensor.
 If the sensor is wrapped to tightly or supplemental tape is used, venous congestion/pulsations may occur
causing erroneous readings.
 Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper
venous outflow from monitored site. Sensor should not be below heart level (e.g. sensor on hand of a patient
in a bed with arm dangling to the floor).
WARNING