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Intended Use
The intended use of this device is to monitor heart rate, respiration rate, invasive
pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation
and pulse rate, central apnea, and ST Segment Analysis.
The device is intended to be used in an environment where patient care is provided by
Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of
the device, who will determine when use of the device is indicated, based upon their
professional assessment of the patient's medical condition.
The device is intended for use in the Adult, Pediatric and Neonatal populations, with
the exception of Arrhythmia and ST Segment Analysis which are not intended for the
neonatal population.
WA R N I N G : T h e I N F I N I T Y M o d u l a r M o n i t o r s h a v e n o t b e e n
t e s t e d a n d a r e 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.
Indications for Use
These devices are capable of monitoring:
z
Heart Rate
z
Respiration Rate
z
Invasive Pressure
z
Non-Invasive Pressure
z
Arrhythmia
z
Temperature
z
Arterial oxygen saturation
z
Pulse rate
z
central apnea
z
ST Segment Analysis
This device will produce visual and audible alarms if any of these parameters vary
beyond preset limits and produce timed or alarm recordings. The devices will connect
to R50 recorders either directly or via the Infinity network.
iv
Infinity Vista
VF6
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