Masimo Radius-7 User manual

Operator's Manual
Radius-7®Wearable Pulse
CO-Oximeter®

www.masimo.com 1 Masimo
For Sale in the USA
These operating instructions provide the necessary information for proper operation of all
models of the Radius-7. 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 Radius-7 are prerequisites for its proper use. Do not operate
Radius-7 without completely reading and understanding these instructions.
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.
Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) for noninvasive 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
directions for use or labeling.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See
instructions for use for full prescribing information, including indications, contraindications,
warnings and precautions.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, and precautions.
Wireless Radio:
Contains: FCC ID: VKF-MWM1 | Model: Radius-7 | Contains: IC: 7362A-MWM1 | IC Model:
MWM1
Masimo Corporation
52 Discovery
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
®, Masimo®, Pulse CO-Oximeter®, Radius-7®, Root®, Adaptive Probe Off Detection®,
APOD®, Discrete Saturation Transform®, DST®, FastSat®, FST®, PVi®, rainbow®, rainbow
Resposable®, RRa®, SET®, Signal Extraction Technology®, Signal IQ®, SpCO®, SpHb®,
SpMet® are federally registered trademarks of Masimo Corporation.

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rainbow Acoustic Monitoring™, RAM™, SpOC™, and X-Cal™ are trademarks of Masimo
Corporation. All other trademarks and registered trademarks are property of their respective
owners.
The use of the trademark Patient SafetyNet™ is under license from University HealthSystem
Consortium.
© 2017 Masimo Corporation

www.masimo.com 3 Masimo
Contents
About this Manual -------------------------------------------------------------------------------------------7
Product Description, Features and Indications for Use----------------------------------------------- 9
Product Description------------------------------------------------------------------------------------- 9
Indications for Use-------------------------------------------------------------------------------------- 9
Contraindications --------------------------------------------------------------------------------------- 9
Safety Information, Warnings and Cautions ---------------------------------------------------------- 11
Safety Warnings and Cautions----------------------------------------------------------------------- 11
Performance Warnings and Cautions--------------------------------------------------------------- 12
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 17
Compliance Warnings and Cautions---------------------------------------------------------------- 17
Chapter 1: Technology Overview ------------------------------------------------------------------------19
Signal Extraction Technology® (SET®)------------------------------------------------------------19
rainbow Pulse CO-Oximetry Technology -----------------------------------------------------------22
rainbow Acoustic Monitoring™ (RAM™) ------------------------------------------------------------26
Chapter 2: System Components-------------------------------------------------------------------------29
General System Description--------------------------------------------------------------------------29
Radius-7 Instrument Module------------------------------------------------------------------------ 30
Radius-7 Battery Module------------------------------------------------------------------------------31
Radius-7 Armband -------------------------------------------------------------------------------------32
Radius-7 Battery Charging Adapter ---------------------------------------------------------------- 33
Chapter 3: Setting Up------------------------------------------------------------------------------------ 35
Unpacking and Inspection -------------------------------------------------------------------------- 35
Preparation for Use ----------------------------------------------------------------------------------- 35
Charging the Radius-7 Battery Module------------------------------------------------------------ 36
Connecting Radius-7 to Root via Bluetooth ------------------------------------------------------ 36
Connecting Radius-7 to Patient SafetyNet --------------------------------------------------------37
Securing Radius-7 to Patient-------------------------------------------------------------------------37
Removing Radius-7 from Patient------------------------------------------------------------------- 40
Chapter 4: Operation-------------------------------------------------------------------------------------- 41
Using the Touchpad ----------------------------------------------------------------------------------- 41
About the Main Screen--------------------------------------------------------------------------------42