Masimo MightySat Rx User manual

MightySat™ Rx
Fingertip Pulse Oximeter
Operator's Manual

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 MightySat™ Rx Fingertip Pulse Oximeter. 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 MightySat Rx are prerequisites for its proper
use. Do not operate MightySat Rx 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.
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.
For professional use. See directions for use for full prescribing information, including
indications, contraindications, warnings, precautions, and adverse events.
Masimo Corporation
40 Parker
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
3148433
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, (ISO 80601-2-61:2011) and related Collateral (IEC
60601-1-11:2010) Standards for which the product has been found to comply by
Intertek.
© 2015 by Masimo Corporation.
Patents: www.masimo.com/patents.htm
Masimo, , Signal Extraction Technology, SET, and Signal I.Q. are federally registered
trademarks of Masimo Corporation.
MightySat is a trademark of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.

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Contents
About this Manual ------------------------------------------------------------------------------------------ 5
Product Description and Indications ---------------------------------------------------------------------7
Product Description--------------------------------------------------------------------------------------7
Indications for Use---------------------------------------------------------------------------------------7
Safety Information, Warnings, and Cautions----------------------------------------------------------- 9
Safety Warnings and Cautions------------------------------------------------------------------------ 9
Performance Warnings and Cautions---------------------------------------------------------------10
Cleaning, Disinfecting, Service Warnings and Cautions----------------------------------------- 12
Compliance Warnings and Cautions----------------------------------------------------------------13
Technology Overview--------------------------------------------------------------------------------------15
Signal Extraction Technology® (SET®)------------------------------------------------------------ 15
Masimo SET® DST ------------------------------------------------------------------------------------- 15
General Description for Oxygen Saturation (SpO2) ----------------------------------------------15
Successful Monitoring for SpO2, PR and PI--------------------------------------------------------16
Functional Oxygen Saturation (SpO2)--------------------------------------------------------------16
General Description for Perfusion Index (PI)------------------------------------------------------16
General Description for Pulse Rate (PR) -----------------------------------------------------------16
General Description for Pleth Variability Index (PVI)--------------------------------------------16
Citations for Pleth Variability Index (PVI) --------------------------------------------------------- 17
Operation---------------------------------------------------------------------------------------------------- 19
MightySat Rx Features --------------------------------------------------------------------------------19
Installing the AAA Batteries ------------------------------------------------------------------------ 20
Using MightySat Rx----------------------------------------------------------------------------------- 20
Turning off MightySat Rx ----------------------------------------------------------------------------- 21
Using the Touchpad -----------------------------------------------------------------------------------22
Navigating the Menu----------------------------------------------------------------------------------23
Connecting to a Smart Device via Bluetooth (Optional)----------------------------------------24
Bluetooth Connection Overview---------------------------------------------------------------------24
Cleaning, Disinfecting, and Service---------------------------------------------------------------------25
Cleaning and Disinfecting MightySat Rx-----------------------------------------------------------25
Service ---------------------------------------------------------------------------------------------------26

MightySat Rx Contents
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Troubleshooting----------------------------------------------------------------------------------------26
Product Support---------------------------------------------------------------------------------------- 27
Limited Warranty --------------------------------------------------------------------------------------28
Exclusions -----------------------------------------------------------------------------------------------28
Limitation of Warranty--------------------------------------------------------------------------------29
Sales & End-User License Agreement--------------------------------------------------------------29
Restrictions -------------------------------------------------------------------------------------------- 30
Specifications ---------------------------------------------------------------------------------------------- 31
Performance Specifications -------------------------------------------------------------------------- 31
Display Ranges ----------------------------------------------------------------------------------------- 31
SpO2 Performance Specifications-------------------------------------------------------------------32
Battery Life----------------------------------------------------------------------------------------------33
Physical Characteristics ------------------------------------------------------------------------------33
Bluetooth LE Wireless Technology Information --------------------------------------------------33
Environment--------------------------------------------------------------------------------------------34
Compliance ---------------------------------------------------------------------------------------------35
Citations-------------------------------------------------------------------------------------------------36
Symbols-------------------------------------------------------------------------------------------------- 37
Guidance and Manufacturer's Declaration - Electromagnetic Emissions --------------------38
Guidance and Manufacturer's Declaration - Electromagnetic Immunity --------------------39
Recommended Separation Distances -------------------------------------------------------------- 42
Index---------------------------------------------------------------------------------------------------------43

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About this Manual
Do not operate the MightySat™ Rx Fingertip Pulse Oximeter without completely reading and
understanding the instructions.
Always use the MightySat Rx precisely in accordance with the directions in this manual,
including site selection and sensor placement. Failure to follow all of the directions in this
manual could lead to inaccurate measurements.
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 to the patient or user (for
example, injury, serious adverse effect, or death).
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 instrument, 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.

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Product Description and Indications
Product Description
The MightySat™ Rx Fingertip Pulse Oximeter is intended as a noninvasive device that
measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), Perfusion Index
(PI), and optional Pleth Variability Index (PVI®).
The following key features are available for the MightySat Rx:
•Masimo SET®technology for SpO2 and pulse rate monitoring in motion and low
perfusion environments.
•Optional Bluetooth®LE wireless technology for the wireless transfer of patient
data to smart devices.
The MightySat™ Rx Fingertip Pulse Oximeter is available in the following versions:
Product Versions Features
MightySat Rx Intended to measure and display arterial oxygen saturation (SpO2),
Pulse Rate (PR), and Perfusion Index (PI).
MightySat Rx,
Bluetooth LE Intended to measure and display arterial oxygen saturation (SpO2), Pulse Rate (PR), and Perfusion Index (PI).
Optional Bluetooth LE radio is intended to transfer of parameter data
to a compatible smart device.
MightySat Rx,
Bluetooth LE and PVI Intended to measure and display arterial oxygen saturation (SpO2), Pulse Rate (PR), Perfusion Index (PI), and optional Pleth Variability
Index (PVI).
Optional Bluetooth LE radio is intended for transfer of parameter data
to a compatible smart device.
Indications for Use
The MightySat™ Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of
functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo
MightySat™ Rx Fingertip Pulse Oximeter is indicated for use with adult and pediatric patients
during both no motion and motion conditions, and for patients who are well or poorly
perfused in hospitals, hospital-type facilities, and mobile environments.