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12-2 Infinity Vista VF6
12 P
ULSE
O
XIMETRY
Intended Use
The Infinity Masimo SET
®
SpO
2
SmartPod
®
is indicated for the continuous
noninvasive monitoring of functional oxygen saturation or arterial hemoglobin (SpO
2
)
and pulse rate (measured by an SpO
2
sensor). It is intended for use under the direct
supervision of a licensed healthcare practitioner (i.e. Physicians, Nurses, and
Technicians).
The Infinity Masimo SET
®
pod is indicated for use with adult, pediatric, and neonatal
patients.
The Infinity Masimo SET
®
pod and accessories are indicated for use during both
motion and non-motion conditions, and for patients who are well or poorly perfused in
hospitals and hospital type facilities.
Overview
Pulse Oximetry monitoring is a non-invasive procedure to determine the functional
oxygen saturation of the patient’s arterial blood (SpO
2
) and an accompanying pulse
rate.
A sensor is attached to the patient (usually the finger) and measures the absorption of
light by the oxyhemoglobin. The light sent through the tissue is transformed into a
signal that is processed by the monitor. The monitor is designed to:
z Display the oximetry waveform.
z Calculate the SpO
2
pulse rate.
z Identify critical levels of arterial oxygen saturation.
Th
WA R N I N G : T h e I n f i n i t y M a s i m o S E T
®
Sp O
2
p o d h a s n o t b e e n
t e s t e d a n d i s n o t a p p r o v e d f o r u s e w i t h i n t h e M R I
e n v i r o n m e n t s i n c e t h e i r f u n c t i o n c o u l d b e c o m p r o m i s e d ,
p o s s i b l y l e a d i n g t o pa t i e n t i n j u r y.
NOTE:
Possession or purchase of the Masimo SET™ SpO
2
pod does not convey any
express 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.