Masimo MightySat Rx User manual

Home Care Manual
MightySat™ Rx Fingertip Pulse
Oximeter

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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.
Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) and are CE Marked 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.
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. See
instructions for use for full prescribing information, including indications, contraindications,
warnings and precautions.
For professional use. See directions for use for full prescribing information, including
indications, contraindications, warnings, precautions, and adverse events.
Masimo Corporation
52 Discovery
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.
Patents: www.masimo.com/patents.htm
Masimo, , Signal Extraction Technology, SET, PVi, RRp, 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.
© 2019 by Masimo Corporation.

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Contents
Glossary------------------------------------------------------------------------------------------------------- 5
Device Description-------------------------------------------------------------------------------------------7
Product Description--------------------------------------------------------------------------------------7
Purpose of the Device (Indications for Use)---------------------------------------------------------7
General Warnings and Precautions---------------------------------------------------------------------- 9
Safety Warnings----------------------------------------------------------------------------------------- 9
Performance Warnings--------------------------------------------------------------------------------10
Cleaning and Service Warnings --------------------------------------------------------------------- 11
Compliance Warnings --------------------------------------------------------------------------------- 11
Risks and Benefits -----------------------------------------------------------------------------------------13
Risks of MightySat Rx ---------------------------------------------------------------------------------13
Benefits of MightySat Rx------------------------------------------------------------------------------13
Description-------------------------------------------------------------------------------------------------- 15
Parts List------------------------------------------------------------------------------------------------- 15
MightySat Rx Features --------------------------------------------------------------------------------16
Basic Setup and Use--------------------------------------------------------------------------------------- 17
Notes: ---------------------------------------------------------------------------------------------------- 19
Advanced Setup and Use--------------------------------------------------------------------------------- 21
Using the Touchpad ----------------------------------------------------------------------------------- 21
Main Menu Options------------------------------------------------------------------------------------22
Connecting to a Smart Device via Bluetooth (Optional) ----------------------------------------22
Notes: ----------------------------------------------------------------------------------------------------24
Appendix ----------------------------------------------------------------------------------------------------25
Troubleshooting----------------------------------------------------------------------------------------25
Specifications-------------------------------------------------------------------------------------------26
Cleaning, Disinfecting, and Service -----------------------------------------------------------------43
Notes: ----------------------------------------------------------------------------------------------------46
Index --------------------------------------------------------------------------------------------------------- 47

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Glossary
Apnea: A sleep disorder in which breathing starts and stops.
Hemoglobin: The protein in red blood cells that transports oxygen from the lungs throughout
the body and carbon dioxide from the tissues back to the lungs.
Necrosis: The death of most or all of the cells in a tissue due to disease, injury, or failure of
the blood supply.
Oxygen Saturation: The percentage of hemoglobin in blood that is bound to oxygen.
Parameter: A parameter is an element of a system that is critical in evaluating the system’s
condition.
Perfusion: The bodily process of delivering blood to the capillary beds.
Pulse Oximeter: A medical device that uses a sensor to indirectly measure oxygen saturation
of blood and pulse rate.
Quality of Service (QoS): Description or measurement of overall performance of the
Bluetooth communication between MightySat Rx and the mobile device as seen by the user.

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Device Description
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®) and Pleth Respiration Rate (RRp).
The following key features are available for the MightySat Rx:
•Masimo SET®technology for SpO2and 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).
Bluetooth LE radio is intended to transfer of parameter data to a
compatible smart device.
MightySat Rx,
Bluetooth LE, PVi
and RRp
Intended to measure and display arterial oxygen saturation (SpO2),
Pulse Rate (PR), Perfusion Index (Pi), and Pleth Variability Index (PVi)
and Pleth Respiration Rate (RRp).
Bluetooth LE radio is intended for transfer of parameter data to a
compatible smart device.
Purpose of the Device (Indications for Use)
The Masimo MightySat™ Rx Fingertip Pulse Oximeter is intended for hospitals, hospital-type
facilities, home environments, and transport.
The Masimo MightySat™ Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot
checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for
adult and pediatric patients during both no motion and motion conditions, and for patients
who are well or poorly perfused.
The Masimo MightySat™ Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot
checking of respiration rate (RRp) for adult patients.