Masimo Rad-97 Operator's Manual

Rad-97 Chapter 11: Specifications
www.masimo.com 164 Masimo
Symbol Description Symbol Description
Analog Out Interface Ethernet
Greater than USB port
Less than
China Restriction of Hazardous
Substances
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The names and content of the
toxic and hazardous
substances or elements shall
be provided in the product
instruction manual
Instructions/Directions for Use/Manuals are available in electronic format
@http://www.Masimo.com/TechDocs
Note: eIFU is not available for CE mark countries.
Citations
[1] SpO
2
, SpCO, and SpMet accuracy was determined by testing on healthy adult volunteers in
the range 60% to 100% SpO
2
, 0% to 40% SpCO, and 0% to 15% SpMet against a laboratory
CO-Oximeter. SpO
2
and SpMet accuracy was determined on 16 neonatal NICU patients ranging
in age from 7 days to 135 days old and weighing between 0.5 kg and 4.25 kg. Seventy-nine (79)
data samples were collected over a range of 70% to 100% SaO
2
and 0.5% to 2.5% HbMet with a
resultant accuracy of 2.9% SpO
2
and 0.9% SpMet. Contact Masimo for testing specifications.
[2] The Masimo rainbow SET technology with Masimo sensors has been validated for no motion
accuracy in human blood studies on healthy adult male and female volunteers with light to
dark skin pigmentation in induced hypoxia studies in the range of 70%-100% SpO
2
against a
laboratory CO-Oximeter and ECG monitor.
[3] The Masimo rainbow SET technology with Masimo sensors has been validated for motion
accuracy in human blood studies on healthy adult male and female volunteers with light to
dark skin pigmentation in induced hypoxia studies while performing rubbing and touching
motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5
Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70%-100% SpO
2
against a laboratory CO-Oximeter and ECG monitor.
[4] The Rad-97 has been validated for low perfusion accuracy in bench-top testing against a
Biotek Index 2™* simulator and Masimo's simulator with signal strengths of greater than 0.02%
and transmission of greater than 5% for saturations ranging from 70%-100%.
[5] Masimo rainbow SET technology with Masimo sensors has been validated for pulse rate
accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator.

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