ZOLL E Series Monitor Defibrillator Rev H SPO2 - Manual (Page 4)

E Series - Pulse CO-Oximetry (SpO
2
, SpCO, and SpMet) Option Insert
2 9650-1211-01 Rev. H
Safety Considerations
Warnings
General
• Before use, carefully read the E Series Operator’s
Guide, these operating instructions, and the
Directions for Use included with each LNCS or
Rainbow sensor being used.
• Only qualified personnel should operate the
E Series Pulse CO-oximeter.
• Do not use the pulse CO-oximeter as an apnea
monitor.
• Do not immerse the E Series device, patient
cables, or sensors in water, solvents, or cleaning
solutions.
• Consider a pulse CO-oximeter an early warning
device. As a trend toward patient deoxygenation is
indicated, blood samples should be analyzed by a
laboratory CO-oximeter to completely understand
the patient's condition.
• If an alarm occurs while the audio alarms are
suspended, the suspended alarm indications will
only be visual displays and symbols.
• Interfering Substances: Carboxyhemoglobin and
methemoglobin may erroneously alter SpO
2
readings. The level of change is approximately
equal to the amount of carboxyhemoglobin or
methemoglobin present. Dyes, or any substance
containing dyes, that alter arterial pigmentation
may cause erroneous readings.
• Elevated levels of methemoglobin will lead to
inaccurate SpO
2
and SpCO measurements.
• Severe anemia may cause erroneous SpO
2
readings.
• Do not use the E Series pulse CO-oximeter or
LNCS sensors during magnetic resonance imaging
(MRI). Induced current could potentially cause
burns. The E Series pulse CO-oximeter may affect
the MRI image, and the MRI unit may affect the
accuracy of the oximetry measurements.
• If using pulse CO-oximetry during full body
irradiation, keep the sensor out of the irradiation
field. If the sensor is exposed to the irradiation, the
reading may be inaccurate or read zero for the
duration of the active irradiation period.
• Carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
• Functional testers cannot be used to assess the
accuracy of the pulse CO-oximeter.
Sensors
• Use only ZOLL / Masimo approved oximetry sensors
for SpO
2
measurements. Other manufacturers’
sensors may cause improper oximeter performance.
• Tissue damage can result from incorrect application or
use of a sensor (for example, by wrapping the sensor
too tightly). Inspect the sensor site as directed in
Directions for Use (included with each sensor) to
ensure skin integrity, correct positioning and sensor
adhesion.
• Do not use damaged sensors or cables.
• Do not modify or alter the sensor in any way.
Alterations or modification of the sensor may affect
performance and/or accuracy.
• Do not use a sensor with exposed optical components.
• Do not sterilize the sensor by irradiation, steam, or
ethylene oxide. See the cleaning instructions included
with each sensor.
• Do not allow the sensor to remain on one site for a
prolonged period of time, especially when monitoring
neonates. Check the application site at regular
intervals - at least every two hours - and change the
site if any compromise in skin quality occurs. Refer to
the Directions for Use included with each sensor.
• Do not attach the SpO
2
sensor to a limb being
monitored with a blood pressure cuff or with restricted
blood flow.
• A poorly applied sensor may give incorrect
measurements. The signal strength indicator can be
used to identify a poorly applied sensor or poorly
chosen site.
• Choose a site with sufficient perfusion to ensure
accurate oximetry values.
• Venous congestion may cause under-reading of actual
arterial oxygen saturation. Therefore, assure proper
venous outflow from the monitored site. The sensor
should not be below heart level, e.g. on the hand of a
patient in a bed with the arm dangling to the floor.
• Certain nail aberrations, nail polish, fungus, etc. may
cause inaccurate oximetry readings. Remove the nail
polish and/or move the sensor to an unaffected digit.
• High ambient light sources such as surgical lights
(especially those with xenon light source), bilirubin
lamps, fluorescent lights, infrared heating lamps, and
direct sunlight can affect the accuracy of SpO
2
readings. To prevent interference from ambient light,
ensure that the sensor is properly applied and cover
the sensor with opaque material if required.