Masimo Radical-7 User manual

Operator's Manual
Radical-7®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 Radical-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 Radical-7 are prerequisites for its proper use. Do not operate
Radical-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.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, and precautions.
Wireless Radio:
Contains: FCC ID: VFK-RAD7A or VFK-RAD7B | FCC Model: Radical-7 | IC ID: 7362A-RAD7A or
7362A-RAD7B | IC Model: VFK-RAD7A or VFK-RAD7B
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
3149433
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES 60601-1:2005/A1, CAN/CSA C22.2 No. 60601-1:2014, and
applicable Particular (EN/ISO 80601-2-61:2011) and related Collateral (IEC
60601-1-8:2006/AMD1:2012) Standards for which the product has been found
to comply by Intertek.
Patents: www.masimo.com/patents.htm
Radical-7®, ®, Adaptive Probe Off Detection®, APOD®, 3D Alarm®, Discrete Saturation
Transform®, DST®, FastSat®, FST®, Masimo®, Pulse CO-Oximeter®, PVi®, Root®,
rainbow®, rainbow Resposable®, RRa®, SatShare®, SedLine®, SET®, Signal Extraction
Technology®, Signal IQ®, SpCO®, SpHb®, and SpMet® are federally registered trademarks
of Masimo Corporation.
3D Desat Index Alarm™, rainbow Acoustic Monitoring™, RAM™, RDS™, ORi™, and SST™ 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.
© 2019 Masimo Corporation

www.masimo.com 3 Masimo
Contents
About This Manual-------------------------------------------------------------------------------------------7
Product Description, Features and Indications for Use----------------------------------------------- 9
Key Features --------------------------------------------------------------------------------------------- 9
Indications for Use-------------------------------------------------------------------------------------10
Contraindications --------------------------------------------------------------------------------------10
Safety Information, Warnings and Cautions ---------------------------------------------------------- 11
Safety Warnings and Cautions----------------------------------------------------------------------- 11
Performance Warnings and Cautions--------------------------------------------------------------- 12
Cleaning and Service Warnings and Cautions ----------------------------------------------------18
Compliance Warnings and Cautions----------------------------------------------------------------19
Chapter 1: Technology Overview ------------------------------------------------------------------------ 21
Signal Extraction Technology® (SET®)------------------------------------------------------------ 21
rainbow Pulse CO-Oximetry Technology -----------------------------------------------------------24
rainbow Acoustic Monitoring™ (RAM™) ------------------------------------------------------------28
Chapter 2: Description ------------------------------------------------------------------------------------31
General System Description-------------------------------------------------------------------------- 31
Functionality of the Radical-7------------------------------------------------------------------------31
Handheld ----------------------------------------------------------------------------------------------- 33
Docking Station --------------------------------------------------------------------------------------- 35
Root------------------------------------------------------------------------------------------------------ 38
Monitor Interface With SatShare------------------------------------------------------------------- 39
Chapter 3: Setup------------------------------------------------------------------------------------------- 41
Unpacking and Inspection --------------------------------------------------------------------------- 41
Powering Radical-7 On, Standby, and Power Off-------------------------------------------------- 41
Initial Battery Charging -------------------------------------------------------------------------------42
Docking Station Setup --------------------------------------------------------------------------------42
Root Setup ----------------------------------------------------------------------------------------------43
SatShare Setup and Use ------------------------------------------------------------------------------43
Philips, Agilent, or HP VueLink Setup --------------------------------------------------------------44
SpaceLabs Flexport Setup ----------------------------------------------------------------------------44
Chapter 4: Operation-------------------------------------------------------------------------------------- 47

Radical-7 Contents
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Using the Touchscreen and Buttons --------------------------------------------------------------- 47
About the Main Screen ------------------------------------------------------------------------------- 51
Accessing Main Menu Options ----------------------------------------------------------------------65
Parameter Settings------------------------------------------------------------------------------------ 67
Sounds ---------------------------------------------------------------------------------------------------83
Device Settings-----------------------------------------------------------------------------------------84
About-----------------------------------------------------------------------------------------------------92
Trends----------------------------------------------------------------------------------------------------93
Chapter 5: Profiles----------------------------------------------------------------------------------------- 97
Profiles Overview--------------------------------------------------------------------------------------- 97
Changing Profiles -------------------------------------------------------------------------------------- 97
Profiles Settings----------------------------------------------------------------------------------------99
Replacing Factory Default Settings for Adult and Neo Profiles ------------------------------100
Chapter 6: Alarms and Messages--------------------------------------------------------------------- 101
About Alarms ----------------------------------------------------------------------------------------- 101
3D Alarms --------------------------------------------------------------------------------------------- 103
Radical-7 Messages---------------------------------------------------------------------------------- 105
Chapter 7: Troubleshooting----------------------------------------------------------------------------- 111
Troubleshooting Measurements-------------------------------------------------------------------- 111
Troubleshooting the Radical-7 ---------------------------------------------------------------------114
Chapter 8: Specifications -------------------------------------------------------------------------------119
Display Range -----------------------------------------------------------------------------------------119
Accuracy (ARMS*) ------------------------------------------------------------------------------------119
Resolution----------------------------------------------------------------------------------------------121
Electrical------------------------------------------------------------------------------------------------121
Environmental-----------------------------------------------------------------------------------------122
Physical Characteristics -----------------------------------------------------------------------------122
Trending----------------------------------------------------------------------------------------------- 123
Alarms ------------------------------------------------------------------------------------------------- 123
Display Indicators------------------------------------------------------------------------------------ 123
Compliance --------------------------------------------------------------------------------------------124
Output Interface ------------------------------------------------------------------------------------- 125
Wireless Specifications ----------------------------------------------------------------------------- 128

Radical-7 Contents
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Guidance and Manufacturer's Declaration-Electromagnetic Emissions-------------------- 131
Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communication
Equipment--------------------------------------------------------------------------------------------- 132
Manufacturer's Declaration-Electromagnetic Immunity -------------------------------------- 134
Recommended Separation Distances ------------------------------------------------------------ 136
Symbols------------------------------------------------------------------------------------------------ 137
Citations ----------------------------------------------------------------------------------------------- 139
Chapter 9: Service and Maintenance------------------------------------------------------------------141
Cleaning ------------------------------------------------------------------------------------------------141
Battery Operation and Maintenance --------------------------------------------------------------141
Replacing the Fuses --------------------------------------------------------------------------------- 143
Performance Verification --------------------------------------------------------------------------- 143
Repair Policy ------------------------------------------------------------------------------------------ 146
Return Procedure------------------------------------------------------------------------------------- 146
Contacting Masimo ---------------------------------------------------------------------------------- 146
Appendix: Concepts of Alarm Response Delay------------------------------------------------------ 149
Concepts of Alarm Response Delay --------------------------------------------------------------- 149
Index ------------------------------------------------------------------------------------------------------- 151

www.masimo.com 7 Masimo
About This Manual
This manual explains how to set up and use Radical-7® Pulse CO-Oximeter®. Important
safety information relating to general use of Radical-7 appears in this manual. Read and
follow any warnings, cautions, and notes presented throughout this manual. The following are
explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.