Instructions for use – Infinity Acute Care System – Monitoring Applications VG6.n 255
SpO2 and Pulse CO-Ox monitoring with Masimo SET MCable
CAUTION
When using the maximum sensitivity setting, the
performance of the sensor off detection may be
compromised. If the device is in this setting and
the sensor becomes dislodged from the patient,
the potential for false readings may occur due to
environmental ‘noise’ such as light, vibration and
excessive air movement. In addition, when a
sensor becomes detached from a patient, it will
have compromised protection against erroneous
pulse rate and arterial saturation readings.
NOTE
An SpO2 sensor can be used during defibrillation,
but the readings may be inaccurate for up to
20 seconds.
NOTE
Possession or purchase of the Masimo SET
MCable or the Masimo rainbow SET MCable
does not convey any expressed or implied license
to use the device with unauthorized sensors or
cables which would, alone, or in combination with
this device, fall within the scope of one or more of
the patents relating to this device.
NOTE
Purchase of this device confers no express or
implied license under any Masimo patent to use
this instrument with any oximetry sensor that is
not manufactured or licensed by Masimo. For a
list of approved sensors, see the instructions for
use Infinity Acute Care System – Accessories.
NOTE
Do not use a functional tester to assess the
accuracy of an SpO2 sensor or an SpO2 sensor
monitor. Since SpO2 sensor measurements are
statistically distributed, only about two-thirds of
those measurements can be expected to fall
within ±A
rms of a CO-oximeter's measured value.
NOTE
A functional tester can be used to measure the
total error of an SpO2 sensor monitor if a
particular calibration waveform has been
independently demonstrated to be accurate for
that system. The functional tester can then
measure how accurately a particular SpO2
sensor is in reproducing the calibration waveform.
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