User's Manual

www.masimo.com 3 Masimo
These operating instructions intend to provide the necessary information for proper operation of the Radius-7 Wearable
Pulse CO-Oximeter. The Operator's Manual describes how Radius-7 information is displayed when used with Root,
including display details as well as accessing and changing user-configurable settings. For additional information
related to Root, refer to the Operator's Manual for Root.
There may be information provided in this manual that is not relevant for your system.
General knowledge of pulse oximetry and an understanding of the features and functions of the Radius-7 Wearable Pulse
CO-Oximeter are prerequisites for proper use.
Do not operate the Radius-7 Wearable Pulse CO-Oximeter without completely reading and understanding these
instructions.
Cleared Use Only: The device and related accessories are CE Marked for non-invasive patient monitoring and may
not be used for any processes, procedures, experiments or any other use for which the device is not intended or
cleared by the applicable regulatory authorities, or in any manner inconsistent with the instructions for use or
labeling.
NOTICE
Purchase or possession of this device does not carry any express or implied license to use with replacement parts which
would, alone or in combination with this device, fall within the scope of one of the relating patents.
For professional use. See instructions for use for full prescribing information, including indications,
contraindications, warnings, precautions and adverse events.
For further information contact:
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
E357969
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005,
CAN/CSA C22.2 No. 60601-1:2008, and applicable Particular
(IEC 60601-2-49:2011, EN/ISO 80601-2-61:2011 and related
Collateral (ANSI/AAMI/IEC 60601-1-8:2006) Standards for
which the product has been found to comply by UL.
Patents: www.masimo.com/patents.htm.
®, Adaptive Probe Off Detection®, APOD®, Discrete Saturation Transform®, DST®, FastSat®, FST®, Masimo®, Pulse
CO-Oximeter®, PVI®, rainbow®, rainbow Resposable®, RRa®, SET®, Signal Extraction Technology®, Signal IQ®,
SpCO®, SpHb®, SpMet® are federally registered trademarks of Masimo Corporation.
Radius-7™, rainbow Acoustic Monitoring™, RAM™ Adaptive Threshold Alarm™, In Vivo Adjustment™ and RRp™ are
trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective
owners.
© 2014 Masimo Corporation.