Masimo MightySat Rx, MightySat Rx Bluetooth LE User Manual
Home Care Manual
MightySat™ Rx Fingertip Pulse
Oximeter
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.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ANSI/AAMI ES 60601-1:2005, CAN/CSA C22.2 No. 60601-1:2008, and applicable
3148433
Particular, (ISO 80601-2-61:2011) and related Collateral (IEC 60601-1-11:2010)
ACCORDANCE WITH
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.
www.masimo.com 1 Masimo
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 (SpO
(Pi), and optional Pleth Variability Index (PVi
®
), Pulse Rate (PR), Perfusion Index
2
) and Pleth Respiration Rate (RRp).
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).
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 (SpO
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.
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) and pulse rate (PR) for
2
General Warnings and Precautions
The MightySat Rx should be used under the care of and following the instructions of your
physician.
WARNING: Always consult your physician regarding clinical decisions. Do not rely on
MightySat Rx as the only basis for medical decisions. Incorrect clinical decisions may result in
harm.
Before using the MightySat Rx, read the following carefully.
Safety Warnings
WARNING: Follow the MightySat Rx instructions to prevent harm or damage to the device.
WARNING: Do not use MightySat Rx if the device enclosure appears damaged or if you
suspect it has been damaged. Exposed electrical circuits can lead to harm.
WARNING: Do not adjust, repair, open, disassemble, or modify MightySat Rx. Such changes
may cause MightySat Rx to malfunction and may lead to false readings.
WARNING: Do not use MightySat Rx near flammable gases such as anesthetics, oxygen,
oxygen-enriched environments, or nitrous oxide to prevent risk of fire.
WARNING: Only use the MightySat Rx to the secure it to the finger. Too much pressure to a
finger can cause skin damage.
WARNING: Check the sensor site every hour to ensure proper blood flow, skin quality, and
sensor placement. Skin damage, pressure necrosis, or inaccurate readings may result.
WARNING: Only use Masimo-approved accessories and devices with MightySat Rx to prevent
damage to the device and inaccurate readings.
WARNING: Keep MightySat Rx away from small children. Small items such as the battery
door, battery, and lanyard may become a choking hazard.
WARNING: Do not use the lanyard during activities where it may become wrapped around the
neck. Strangulation may occur.
WARNING: Do not touch MightySat Rx while defibrillating a patient to prevent damage to
the device.
WARNING: To prevent harm to the patient and damage to MightySat Rx:
• Do not set MightySat Rx on a wet surface.
• Do not immerse it in liquid.
• Do not attempt to sterilize it.
• Clean only with the solutions listed in this manual.
• Do not clean MightySat Rx while it is connected to the patient.
CAUTION: Do not use the MightySat Rx near devices that are sensitive to magnets. The
magnet provided with the MightySat Rx could hinder proper operation of the device.
Note: Use and store MightySat Rx as directed in the Specifications section in this manual.
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MightySat Rx General Warnings and Precautions
Performance Warnings
WARNING: Do not use MightySat Rx as an apnea monitor. MightySat Rx does not have
alarms to alert you when the patient’s breathing is not normal or has stopped.
WARNING: Do not self-diagnose or self-medicate on the basis of the measurements. Always
consult your doctor.
WARNING: Do not use MightySat Rx for continuous monitoring. It is intended for spot-check
use only. No alarms are provided.
WARNING: Check the following to prevent inaccurate (or no) readings:
• MightySat Rx is applied correctly.
• Blood pressure cuff is not applied to the same arm as a sensor site.
• Sensor site is free of nail polish, acrylic nails, glitter, etc.
• Sensor site is free of moisture, birthmarks, skin discoloration, and any foreign
objects in the path of the sensor.
• MightySat Rx is placed where other devices may not interfere with its operation.
• The patient does not have any medical conditions that might interfere with
readings.
• Contact your physician if you have concerns.
WARNING: Inaccurate respiration rate (RRp) measurements may be caused by:
• Low arterial perfusion
• Motion
CAUTION: Avoid using the MightySat Rx under bright light sources and direct sunlight to
minimize interference that may result in no or inaccurate readings.
CAUTION: Keep the MightySat Rx away from electrical equipment that emits radio
frequencies to minimize radio interference. Radio interference may result in no or inaccurate
readings.
CAUTION: Keep the MightySat Rx away from electrical equipment that emits radio
frequencies to minimize radio interference. Radio interference may result in no or inaccurate
readings.
CAUTION: When using MightySat Rx with a smart device, keep both devices within the
recommended range of each other (see Specifications for details); moving outside of this
range may cause a loss in connection with the smart device.
CAUTION: When using MightySat Rx with a smart device, relocate the devices away from
sources that may interfere with the Bluetooth connection. The presence of other devices that
may create radio frequency interference (RFI) may result in loss of Quality of Service (see
Specifications for details) of the Bluetooth connection. Devices that may cause RFI include
but are not limited to the following: other cellular telephones, wireless PC and tablets, pagers,
Bluetooth devices, devices with remote controls, and baby monitors.
Note: The MightySat Rx display may be difficult to view when exposed to direct sunlight or
bright lights.
Note: The MightySat Rx display will shut off automatically if there are no readings.
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MightySat Rx General Warnings and Precautions
Note: Please contact health professionals if Respiration Rate is <8 or >24 respirations per
minute.
Cleaning and Service Warnings
WARNING: Do not re-manufacture, recondition or recycle MightySat Rx to prevent harm or
damage to the device.
WARNING: To prevent damage to MightySat Rx:
• Remove batteries when the MightySat Rx will not be in use for more than 30 days
• Replace both batteries at the same time to avoid mixing fully and partially
charged batteries.
• Use only AAA alkaline batteries.
WARNING: Dispose of battery according to local regulations.
CAUTION: Perform only the maintenance procedures specifically described in this manual to
prevent damage to the device. For all other maintenance or repair, return MightySat Rx to
Masimo for servicing.
CAUTION: Do not clean MightySat Rx with undiluted bleach, petroleum-based products,
acetone, or other harsh solvents. Clean only with the solutions specified in this manual to
prevent damage to the device.
CAUTION: Do not touch, press, or rub the display panels with anything that could scratch the
display, such as abrasive cleaning compounds, instruments, brushes, or rough-surface
materials. These can damage the device.
CAUTION: Do not submerge MightySat Rx in liquid or attempt to sterilize the MightySat Rx
by any method to prevent damage to the device.
Compliance Warnings
WARNING: Changes or modifications not expressly approved can void the user’s authority to
operate the equipment.
WARNING: The frequency bands of this device (2.4 GHz and 5.15 to 5.25 GHz) are only for
indoor use, in accordance with international telecommunication requirements.
CAUTION: Comply with local laws and regulations when disposing of MightySat Rx, its
accessories, and its battery.
Note: When using MightySat Rx with a device with wireless features, consideration should be
taken to local government frequency allocations and technical parameters to minimize the
possibility of interference to/from other wireless devices.
Note: In accordance with international telecommunication requirements, the frequency band
of 2.4 GHz is only for indoor usage to reduce potential for harmful interference to co-channel
mobile satellite systems.
Note: This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that may cause
undesired operation.
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MightySat Rx General Warnings and Precautions
Note: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user
is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Consult the dealer or an experienced radio/TV technician for help.
Note: This equipment has been tested and found to comply with the Class B limits for
medical devices according to the IEC 60601-1-2: 2007, Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection against harmful interference in all
establishments, including domestic establishments.
Note: This Class B digital apparatus complies with Canadian ICES-003.
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Risks and Benefits
Before using any medical device, it is important to consult your physician and weigh the risks
and benefits.
The following section describes the Benefits and Risks associated with using MightySat Rx.
Risks of MightySat Rx
• As with all medical electrical devices, there is always a risk of electrical,
mechanical, and fire hazards. However, these risks have been mitigated through
the design and testing of MightySat Rx.
• As with all devices with small parts, there is always a risk of a child’s swallowing a
component or choking. Keep small parts away from small children to prevent such
hazards.
• As with all items applied directly to the skin, there is always a risk of skin irritation,
pressure injury, and general discomfort while a sensor or cuff is applied to a
patient. Periodically check the areas where the patient’s skin makes contact with
Benefits of MightySat Rx
the sensor or blood pressure cuff to prevent potential issues.
• MightySat Rx is a portable fingertip device able to provide pulse oximetry
measurements including oxygen saturation (SpO
index (Pi), Respiratory Rate (RRp), and pleth variability index (PVi) within a home
), pulse rate (PR), perfusion
2
environment.
• The MightySat Rx with optional Bluetooth can wirelessly transfer data to a
compatible smart device for a larger display and/or storage of data.
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