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Masimo
Product Description, Features, and
Indications for Use
Product Description and Features
Pronto® Pulse CO-Oximeter® is a noninvasive device intended to monitor functional oxygen
saturation of arterial hemoglobin (SpO2), pulse rate (PR), perfusion index (PI), and total
hemoglobin (SpHb®).
The following key features are available for Pronto:
•
Masimo SET® and rainbow® SET technology performance.
•
SpO2 and pulse rate monitoring in motion and low perfusion environments.
•
Noninvasive spot-checking of total arterial hemoglobin concentration (SpHb).
•
Download capabilities to transfer data from the device to a computer.
Indications for Use
The Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories are indicated for
noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2),
pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET® Pronto
Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and
pediatric individuals during both no motion and motion conditions, and for individuals who
are well or poorly perfused in clinical and nonclinical settings (e.g., hospitals, hospital-type
facilities, mobile environments, homes, clinics, physician offices, blood donation facilities,
and ambulatory surgery centers).
Contraindications
Pronto is contraindicated for use as an apnea monitor. Pronto is also contraindicated for use
as a continuous monitor.