User's Manual Part 1

1-12
1.3.7.3. SpO
2
The pulse oximeter should not be used as the sole basis for medical decisions. It must be used
in conjunction with clinical signs and symptoms.
Do not start or operate the pulse oximeter unless the setup was verified to be correct.
Do not use the pulse oximeter if it appears or is suspected to be damaged.
Use only MRI compatible SpO
2
accessories (See MRI Accessory list in Section 9).
Use only the Fiber-optic SpO
2
sensors recommended by IRadimed Corporation. A listing of
these can be found in the Accessory List within this manual, or by contacting
IRadimed
Corporation directly.
The Fiber-optic SpO
2
sensors are constructed of fiber-optic glass and should always be
handled with care to prevent damage. Improper handling can reduce both the signal
transmission quality and the SpO
2
measurement sensitivity. Improper handling can also shorten
the SpO
2
sensor's useful life.
The pulse oximeter feature in this monitor is designed to display functional SpO
2
values.
SpO2 is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
The pulse oximeter pulsatile waveform is not proportional to the pulse amplitude, but adjusts the
waveform amplitude as needed for proper viewing.
Avoid placement of the SpO
2
probe on the same limb with an inflated blood pressure cuff. Cuff
inflation could result in inaccurate readings and false alarm violations.
SpO
2
monitoring requires the detection of valid pulses to correctly determine SpO
2
and Heart
Rate values. During conditions of gross artifact, or in the absence of valid pulses, the SpO
2
and
/ or pulse rate values may not be correct.
The SpO
2
monitoring portion of this monitor is intended to measure arterial hemoglobin oxygen
saturation of functional hemoglobin (saturation of hemoglobin functionally available for
transporting oxygen in the arteries). Significant levels of dysfunctional hemoglobins, such as
carboxyhemoglobin or methemoglobin, may affect the accuracy of the measurement. Also,
Cardiogreen and other intravascular dyes may, depending on their concentration, affect the
accuracy of the SpO
2
measurement.
Always shield the SpO
2
sensor from extraneous incident light sources. Such extraneous light
can cause SpO
2
reading or pulse detection errors.
Frequently inspect the SpO
2
sensor site for possible pressure tissue necrosis during prolonged
monitoring. Reposition the sensor at least every 4 hours. Special care should be exercised
when tape is used to secure the sensor, as the stretch memory properties of most tapes can
easily apply unintended pressure to the sensor site.
The pulse oximeter is not an apnea monitor.
The pulse oximeter may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.