Operator's Manual

Rad-97 Product Description, Features and Indications for Use
www.masimo.com 11 Masimo
Indications for Use
The Masimo Rad-97 and Accessories are indicated for hospitals, hospital-type facilities,
mobile, and home environments.
The Masimo Rad-97 and Accessories can communicate with network systems for
supplemental remote viewing and alarming (e.g., at a central station).
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO
2
), pulse rate (PR),
carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin
concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rad-97 and Accessories are
indicated for use with adult, pediatric, and neonatal patients during both no motion and
motion conditions, and for patients who are well or poorly perfused. In addition, the Masimo
Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring
data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of
arterial hemoglobin (SpO
2
) and pulse rate (PR) to multi-parameter devices for the display on
those devices.
The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making
diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is
intended to be used in conjunction with additional methods of assessing clinical signs and
symptoms.
The optional NomoLine Capnography product family is intended to be connected to other
medical backboard devices for monitoring of breath rate and CO
2
. The NomoLine
Capnography product family is intended to be connected to a patient breathing circuit for
monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The
environment is the operating suite, intensive care unit and patient room. The intended
patient population is adult, pediatric and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive
measurement of arterial blood pressure. The NIBP module is designed to measure blood
pressure for patient population described in the following table:
Patient Population Approximate Age Range
Newborn (neonate) Birth to 1 month of age
Infant 1 month to 2 years of age
Child 2 to 12 years of age
Adolescent 12-21 years of age
Adult 21 years of age and older
Contraindications
The Rad-97 is not intended for use as an apnea monitor.