Masimo Rad-97 Operator's Manual

Rad-97 Product Description, Features and Indications for Use
www.masimo.com 10 Masimo
Feature NOT AVAILABLE in U.S.A. and territories relying on FDA market clearance
PR
Pi
PVi
SpHb
SpCO
SpOC
SpMet
RRa
RRp X
ORi X
ATA X
In-Vivo X
NIBP
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

Masimo Rad-97 Specifications

General

Display Size	7 inches
SpO2 Accuracy	±2% (70-100%)
Pulse Rate Accuracy	±3 bpm
Perfusion Index Range	0.02% to 20%
Pleth Variability Index Range	0% to 100%
SpO2 Range	0% to 100%
SpHb Range	0 to 25 g/dL
SpCO Range	0% to 40%
Battery Type	Rechargeable lithium-ion
Operating Temperature	5°C to 40°C (41°F to 104°F)
Storage Temperature	-20°C to 60°C (-4°F to 140°F)
Humidity Range	10% to 95% non-condensing
Display	Color touchscreen
Connectivity	Wi-Fi, Ethernet, Bluetooth
Power Supply	100–240 VAC, 50–60 Hz
Battery Life	Approximately 4 hours
Measurements	SpO2, Pulse Rate, Perfusion Index, Pleth Variability Index, SpHb, SpOC, SpMet, SpCO
Pulse Rate Range	25 to 240 bpm
HbCO Range	0-99%
MetHb Range	0-99%
SpMet Range	0-99%
Data Storage	Internal memory
Alarms	Audible and visual alarms for all parameters