Masimo Rad-97 Operator's Manual

www.masimo.com 9 Masimo
Product Description, Features and
Indications for Use
Product Description
Rad-97™ Pulse CO-Oximeter® is a non-invasive device intended to monitor functional oxygen
saturation of arterial hemoglobin (SpO
2
), pulse rate (PR), perfusion index (Pi), and Pleth
Variability Index (PVi) along with optional non-invasive measurements of total hemoglobin
(SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet),
Acoustic Respiration Rate (RRa), Oxygen Reserve Index (ORi)*, and Pleth Respiration Rate
(RRp)*.
The following key features are available for Rad-97:
• Masimo SET and rainbow SET technology performance.
• SpO
2
and pulse rate monitoring in motion and low perfusion environments.
• Continuous and non-invasive monitoring of carboxyhemoglobin (SpCO),
methemoglobin (SpMet), and total hemoglobin (SpHb).
• Respiration Rate (RR) is measured using:
• Acoustic (RRa)
• Plethysmographic waveform (RRp)*
• Oxygen Reserve Index (ORi)*, an index to measure changes in oxygen states under
hyperoxic conditions.
• Wireless radio for transfer of parameter data.
• Sleep Study and optional Home operational modes.
• Optional integrated Noninvasive Blood Pressure (NIBP) technology.
• Designed for third party measurement expansion to allow for additional platform
measurements.
• Ability to display data on a secondary display.
For all prescribing information and instructions for use of the compatible medical devices
connected to Rad-97, see the Operator's Manual or Instructions for Use for the specific
medical device.
* Currently not available in the U.S.A. and territories relying on FDA market clearance.
Regulatory Notice
The following features are NOT AVAILABLE.
Feature NOT AVAILABLE in U.S.A. and territories relying on FDA market clearance
SpO
2

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