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.
www.masimo.com 7 Masimo
) 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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Description
Parts List
MightySat Rx consists of the following items:
Item Description
1 MightySat Rx
2 Batteries
3 Lanyard
4 Carrying Case
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MightySat Rx Description
in
MightySat Rx Features
Item Description Function
1 Enclosure Clip Attach lanyard to the clip.
2 Bluetooth
Displays when Bluetooth is enabled on the device.
Indicator
(Optional)
3 Battery Status
Displays remaining battery life.
Indicator
4 Main Screen Display for measurements and indicators.
Note: Numbers are dim when confidence in the measurement is
low.
5 Waveform and SIQ
or Pulse Bar
When the waveform option is turned on, the Waveform and SIQ
line display. The height of the SIQ line shows the confidence in
the measurement displayed.
When the waveform option is turned off, the Pulse Bar displays
the pulse rate. The height of the Pulse Bar shows the confidence
in the measurement displayed.
6 Touchpad User interface for settings (see Using the Touchpad on page 21
this manual).
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Basic Setup and Use
The following steps include basic setup and use for operating the MightySat Rx device.
The MightySat Rx requires two alkaline AAA batteries to operate. To install batteries, follow
the steps below:
Note: MightySat Rx will not work if the batteries are inserted backwards.
1. Place the MightySat Rx with the display screen facing
down.
2. Push lightly on the battery button (identified by the
arrow) to release and remove the battery cover.
3. Insert two new AAA alkaline batteries to match the
labels (+ and -) inside of the battery case.
4. Snap the battery door back onto the device.
CAUTION: Ensure that the battery door is installed
before use.
MightySat Rx turns on when the device is opened to place on a finger.
www.masimo.com 17 Masimo
MightySat Rx Basic Setup and Use
1. To open the MightySat Rx, squeeze the back of the device (1).
2. Insert the ring finger with the display facing up (2). For a right-handed person,
this would be the left hand ring finger, for a left-handed person, this would be the
right hand ring finger.
3. Once the device is correctly placed on the finger, release the device to close. The
display should be facing up (3).
4. The tip of the finger should touch the finger stop as shown in the image below.
Note: Ensure the finger is correctly positioned.
After the MightySat Rx is correctly placed on the finger, readings display.
Note: If readings are not displayed, see Troubleshooting on page 25.
CAUTION: Do not press the top of the device while on the finger.
WARNING: Do not attempt to secure the MightySat Rx to the finger using additional
pressure.
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MightySat Rx Basic Setup and Use
The MightySat Rx turns off after removing it from the finger.
Notes:
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Advanced Setup and Use
Using the Touchpad
The multi-function Touchpad on MightySat Rx is located below the
display screen.
Note: The display is not a touch screen.
Desired
Function
Rotate Main
Screen for
better view
while on
finger.*
Enter the
Menu Screen.
Navigate the
Menu Screen.
Select a menu
item.
Exit the Menu
Screen.
Required Action Description
Tap and release
the Touchpad to
rotate once in a
clockwise
direction.
Press and hold
the Touchpad.
Swipe left or right
on the Touchpad.
Touch and
release the
Touchpad.
Swipe right on
the Touchpad to
display arrow,
then touch and
release.
The Main Screen can be rotated for best viewing angle.
The menu allows changes to MightySat Rx settings.
See Main Menu Options on page 22.
Switches between menu items on the Menu Screen.
Select an item on the Menu Screen to switch between
options or enable/disable that option.
See Main Menu Options on page 22.
Returns to the Main Screen.
See Main Menu Options on page 22.
* This function does not rotate the Menu Screen.
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MightySat Rx Advanced Setup and Use
Main Menu Options
Use the Touchpad to navigate the Menu Options. See Using the Touchpad on page 21.
The Menu options are:
Menu Icon Menu Option Description
Back Return to Main Screen. N/A N/A
Waveform
Brightness Change the brightness of the display. 100%
Bluetooth
(Optional)
About
* When On, the icon is white, when Off, the icon is gray (dimmed).
Allows the user to choose to display
the waveform on the screen.
For connection with a smart device.
Enables or disables Bluetooth LE.
Hardware and software information
about the device. Serial number;
software version; Bluetooth LE Mac
Address
Default
Setting
On On or Off *
On On or Off *
N/A N/A
Options
25%, 50%,
75%, and
100%
Connecting to a Smart Device via Bluetooth (Optional)
Note: Bluetooth LE is an optional feature available on specific versions of MightySat Rx for
use with compatible smart devices. For a full list of compatible smart devices, see
www.masimoprofessionalhealth.com.
Bluetooth Connection
The MightySat Rx provides a Bluetooth LE wireless option to allow connection to a
compatible smart device. The Bluetooth communication is only available to smart devices
using the Masimo Professional Health App. When a Bluetooth connection is established the
Bluetooth connected icon will appear. MightySat Rx can only communicate to a single smart
device at one time to minimize the risk of unauthorized access.
Note: The MightySat Rx requires the use of the Masimo Professional Health app to
communicate to a compatible smart device.
www.masimo.com 22 Masimo
MightySat Rx Advanced Setup and Use
Pair MightySat Rx to Smart Device
1. Ensure the Bluetooth is enabled on the smart device through the device settings.
2. From your compatible smart device, perform one of the following:
TM
• For Android
• For Apple
3. Search and download the “Masimo Professional Health” app.
4. Launch the Masimo Professional Health app.
5. Turn the MightySat Rx Bluetooth On. See Main Menu Options on page 22 of this
manual for further instructions.
6. Follow the Masimo Professional Health app on-screen instructions to pair a
device.
7. When the Masimo Professional Health app identifies the MightySat Rx,
press/select it to pair.
8. Once MightySat Rx is connected to a smart device, the Masimo Professional
Health app returns to the Main screen.
Note: A connection icon will appear on the MightySat Rx device when a Bluetooth
connection has been established.
9. Place MightySat Rx on the patient's finger. Confirm that readings on MightySat Rx
and readings displayed on the Masimo Professional Health app are the same
without a delay greater than 10 seconds.
Note: If the delay is greater than 10 seconds, move the MightySat Rx closer to the
smart device and repeat the connection process.
Note: To prevent unauthorized connection to the MightySat Rx, turn off the
optional Bluetooth LE feature on the MightySat Rx when a connection is not
required.
CAUTION: When using MightySat Rx (optional Bluetooth version) with a smart
device, keep both devices within range of each other (see Specifications on page
26 for details); moving out of range may cause a loss in connection with the smart
device.
CAUTION: When using MightySat Rx (optional Bluetooth version) with a smart
device, relocate the devices away from sources that may interfere with the
Bluetooth connection. Interference may result in loss of Quality of Service (see
Specifications on page 26 for details) of the Bluetooth connection.
-powered devices, go to the Google PlayTM store.
®
devices, go to the App StoreSM.
Verify Paired MightySat Rx
1. On the smart device, access the Masimo Professional Health app Options.
2. Locate Paired Device.
Note: Sensor Mode is always Bluetooth Sensor when using MightySat Rx with a
smart device.
3. Compare the Paired Device information to the BT SN (Bluetooth Serial Number)
displayed on the MightySat Rx About screen, see Main Menu Options on page 22
for information on accessing the About screen.
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MightySat Rx Advanced Setup and Use
Disconnect Paired MightySat Rx
1. On the smart device, access the Masimo Professional Health app Options.
2. Press/select the Paired Device information.
3. Select Forget this Device. MightySat Rx will be disconnected from the smart
device. MightySat Rx will need to be paired if it is to be used with this smart device
again.
Notes:
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Appendix
Troubleshooting
Troubleshooting
Error or Error Message Possible Causes Recommended Solutions
A red battery symbol
displays on Main Screen
Device does not display
readings
Device display does not
turn on
Numbers appear dim
Low battery Replace low batteries as soon as
• Incorrect finger
placement
• Incorrect battery
orientation
• No battery
• Low battery
• Environmental
influences
• No battery
• Incorrect battery
orientation
• Device damaged
• Brightness set low
• Exposed to bright
lights or sunlight
• Incorrect finger
placement
• Measurement site
may be poorly
perfused
possible. (see Installing the AAA
Batteries in this manual)
• Wait for measurement
(Optional PVI may take a
maximum of 5 minutes
before initial measurement)
• Reposition finger (see Basic
Setup and Use on page 17 in
this manual)
• Re-orient batteries
• Replace with new batteries
• Relocate device
• Contact Masimo Technical
Services
• Replace with new batteries
• Re-orient batteries
• Contact Masimo Technical
Services
• Check brightness setting in
menu
• Relocate device so that it is
not directly under bright
lights
• Reposition finger (See Basic
Setup and Use on page 17 in
this manual)
• Contact Masimo Technical
Services
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MightySat Rx Appendix
Error or Error Message Possible Causes Recommended Solutions
Device keeps turning off
while on the finger
Measurement does not
display on the smart device
using optional Bluetooth
LE
Specifications
Display Ranges
• Incorrect finger
placement
• Environmental
influences
• Device damaged
• Bluetooth LE not
connected
• Compatible app not
installed on smart
device
• Device damaged
• Smart device
damaged
• Reposition finger (See Basic
Setup and Use on page 17 in
this manual)
• Relocate device
• Replace with new batteries
• Contact Masimo Technical
Services
• Confirm Bluetooth LE is on
for the MightySat Rx and the
smart device
• Confirm a compatible app is
installed on the smart device
• Close and re-launch the
compatible app on the smart
device
• Check that MightySat Rx is
connected to the correct
smart device
• Contact Masimo Technical
Services
Parameter Display Ranges
SpO2 (Oxygen Saturation) 0% to 100%
PR (Pulse Rate) 25 bpm to 240 bpm
Pi (Perfusion Index) 0.02% to 20%
PVi (Pleth Variability Index) 0% to 100%
RRp (Respiration Rate) 4 rpm to 70 rpm
The emitted wavelengths range from 600 nm to 1000 nm and the peak optical power is less
than 15 mW. Information about the wavelength range can be especially useful to clinicians.
www.masimo.com 26 Masimo
MightySat Rx Appendix
Performance Specifications
SpO2 Accuracy
Condition Range Population A
RMS
*
No Motion [1] 70% to 100% Adults, Pediatrics 2%
Motion [2] 70% to 100% Adults, Pediatrics 3%
Low perfusion [3] 70% to 100% Adults, Pediatrics 2%
See the SpO2 Performance Specifications on page 28 for additional SpO2 accuracy
information.
Pulse Rate (PR)
Condition Range Population A
RMS
*
No Motion [4] 25 bpm to 240 bpm Adults, Pediatrics 3 bpm
Motion [4] 25 bpm to 240 bpm Adults, Pediatrics 5 bpm
Low perfusion [4] 25 bpm to 240 bpm Adults, Pediatrics 3 bpm
Respiration Rate (RRp) [5]
Range Accuracy
4 rpm to 70 rpm 3 rpm A
RMS
*
±1 rpm mean error
See RRp Performance Specifications for additional RRp accuracy information.
* A
accuracy is a statistical calculation of the difference between device measurements and
RMS
reference measurements. Approximately two-thirds of the device measurements fell within
+/- A
of the reference measurements in a controlled study.
RMS
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MightySat Rx Appendix
SpO2 Performance Specifications
Table below provides A
Rx with Masimo SET
(Accuracy Root Mean Square) values measured using the MightySat
RMS
®
Oximetry Technology in a clinical study under no motion conditions.
Measured A
Range A
RMS
Values
RMS
90% – 100% 1.08%
80% – 90% 1.95%
70% – 80% 1.79%
Overall Claimed Accuracy Value
Range A
RMS
70% – 100% 2%
The below Bland-Altman plot represents the correlation of (SpO2 - SaO2) versus (SpO2 +
)/2 under no motion with an upper 95% and lower 95% limits of agreement.
SaO
2
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MightySat Rx Appendix
Figure 1: MightySat™ Rx Fingertip Pulse Oximeter (A
70-100%)
RMS
RRp Performance Specifications
The below Bland Altman plots represent the correlation of RRp and the reference respiration
rate in three different studies, each with upper 95% and lower 95% limits of agreement.
Figure 2: Bland-Altman plot of the RRp measurement with respect to the respiration rate value
on a simulator (RRref)
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MightySat Rx Appendix
Figure 3: Subject by subject Bland-Altman plot of the RRp measurement with respect to the
respiration rate determined by clinician-scored capnograms (RRref_c) from a clinical study of
healthy volunteers
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MightySat Rx Appendix
Figure 4: Subject by subject Bland-Altman plot of the RRp measurement with respect to the
respiration rate determined by clinician-scored capnograms (RRref_c) from a clinical study of
hospitalized patients
Medical Conditions
Medical Conditions from clinical study of hospitalized patients
N N
Autoimmune
Psoriasis 1 Cellulitis 1
Cardiovascular
Atrial Septal Defect 1 Ventral Hernia 2
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Infections
Muscular
MightySat Rx Appendix
Coronary Disease 1 Musculoskeletal and Connective Tissue
Hypertension 20
Endocrine/Metabolic
Diabetes (Type I or II) 2 Osteoarthritis 4
Hyperlipidemia 8 Neoplasm
Hypomagnesemia 1 Lipoma 1
Hypothyroidism 2 Malignant Tumor 1
Morbid Obesity 6 Neurological
Gastrointestinal
Acid Reflux 1 Neuropathy 1
Crohn's Disease 1 Restless Leg Syndrome 1
Emesis 1 Ophthalmology
GERD 3 Glaucoma 2
Hiatal Hernia 1 Other
Degenerative Joint Disease 1
Dupuytrens Contracture (Right Hand) 1
Bilateral Hand Tremors 1
Reflux Disease 1 Lethargy 1
Genitourinary
Bladder Cancer 1 Renal
Breast Cancer/Breast Cancer History 2 Kidney Disease 2
Cervical Cancer 1 Kidney Failure 1
Endometrial Cancer 1 Kidney Stones 1
Fibroid Uterus 1 Respiratory
www.masimo.com 32 Masimo
Subdural Hematoma 1
MightySat Rx Appendix
Rectocele 1 Asthma 2
Hematology
Pneumonia 2
Acute Blood Loss Anemia 1 Risk of Sleep Apnea 3
Anemia 1 Sleep Apnea 13
Blood Clotting Disorder/Unspecified 1 Vascular
Leukocytosis 1 Raynaud Phenomenon 1
Sickle Cell Disease 1
Hepatobiliary
Cholelithiasis 2
Chronic Cholecystitis 1
Gall Stones 2
Liver Cyst 1
Battery Life
Item Description
Operating 1.5 Volt AAA Battery (2)
Battery Life ≥15 hours (screen brightness at 50%)
www.masimo.com 33 Masimo
MightySat Rx Appendix
Environment
Item Description
Operating Temperature 5°C to 40°C (41°F to 104°F)
Storage Temperature -40°C to 70°C (-40°F to 158°F)
Operating Humidity 10% to 95% non-condensing
Storage Humidity 10% to 95% non-condensing
Atmospheric pressure 540 mBar to 1060 mBar
Physical Characteristics
Item Description
Dimensions
3” x 1.7” x 1.3”
(7.6 cm x 4.3 cm x 3.3 cm)
Weight without Battery 0.2 lbs. (90g)
Compliance
Safety Compliance
ANSI/AAMI ES60601-1
CSA C22.2 No. 60601-1
IEC/EN 60601-1
IEC 60601-1-6
IEC 60601-1-11
ISO 80601-2-61
www.masimo.com 34 Masimo
MightySat Rx Appendix
EMC Compliance
IEC 60601-1-2, Class B
ISO 80601-2-61: Clause 202, 20 V/m radiated immunity
Equipment Classifications per IEC 60601-1
Degree of Protection against
Type BF applied part
electric shock
Mode of Operation Continuous Operation
Degree of Protection from
Liquid Ingress
IP23, Protection from ingress of particulates > than 12.5 mm
and ingress from spraying water.
Environment Not for use in the presence of flammable anesthetics
Bluetooth LE Wireless Technology Information
Bluetooth LE Wireless Technology Information
Modulation Type GFSK
Max. Output Power -1 dBm
Frequency Range 2402 MHz - 2480 MHz
Antenna Peak Gain -7 dBi
Recommended Range ~10 feet (~3 meters) line-of-sight
Quality of Service (QoS) Delay <10 seconds
Security Proprietary binary protocol
Radio Compliance
Radio Modes Bluetooth LE
www.masimo.com 35 Masimo
MightySat Rx Appendix
Radio Compliance
USA FCC ID: VKF-MSAT01A
FCC parts 15.207 and 15.247
Canada IC-7362A-MSAT01A
RSS-210
Europe EN 300 328
EN 301 489-17
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Guidance and Manufacturer's Declarations - Electromagnetic Emissions
The ME Equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME Equipment should assure that it is used in such an
environment.
Emission Test Compliance Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic
emissions
Group 1
Class B
N/A
ME Equipment uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
This device is not intended to be operated in the home
environment. This device has not been evaluated for use in
aircrafts.
IEC 61000-3-2
Voltage
fluctuations/
flicker
N/A
emissions
IEC 61000-3-3
www.masimo.com 36 Masimo
MightySat Rx Appendix
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The ME Equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME Equipment should assure that it is used in such an
environment.
Immunity Test IEC 60601
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Test Level
+6 kV contact
+8 kV air
± 2 kV for
power supply
lines
± 1 kV for
input/output
lines
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
<5 % UT (>95
% dip in UT)
for 0,5 cycle
40 % UT (60 %
dip in UT) for
5 cycles
70 % UT (30 %
dip in UT) for
25 cycles
<5 % UT (>95
% dip in UT)
for 5 s
Compliance
Level
+6 kV
contact
+8 kV air
N/A Mains power quality should be that of a
N/A Mains power quality should be that of a
N/A Mains power quality should be that of a
Electromagnetic Environment Guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
typical commercial or hospital
environment.
typical commercial or hospital
environment.
typical commercial or hospital
environment. If the user of the [ME
EQUIPMENT or ME SYSTEM] requires
continued operation during power
mains interruptions, it is recommended
that the [ME EQUIPMENT or ME
SYSTEM] be powered from an
uninterruptible power supply or a
battery.
Power frequency
(50/ 60 Hz)
magnetic field
IEC 61000-4-3
www.masimo.com 37 Masimo
3 A/m 3 A/m Power frequency magnetic fields should
be at levels characteristic of typical
location in a typical hospital
environment.
MightySat Rx Appendix
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Portable and mobile RF communications equipment should be used no closer to any part of
the ME Equipment, including cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Immunity Test IEC 60601
Test Level
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
ISO 80601-2-61,
Clause 202
3 Vrms 150
kHz to 80 MHz
3 V/m 150 kHz
to 80MHz
20 V/m 80
MHz to 2.5
GHz
Compliance
Level
N/A
3 V/m
20 V/m
Recommended separation distance
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey
a
, should be
less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
www.masimo.com 38 Masimo
MightySat Rx Appendix
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the ME Equipment is used
exceeds the applicable RF compliance level above, the ME Equipment should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the ME Equipment.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]
V/m.
Recommended Separation Distances
Recommended Separation Distance Between Portable and Mobile RF Communication
Equipment and the ME Equipment
The ME Equipment is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the ME Equipment can help
prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the ME Equipment as
recommended below, according to the maximum output power of the communication
equipment.
Rated maximum
Separation Distance According to Frequency of Transmitter (m)
output power of
transmitter (W)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5GHz
0.01 0.12 0.018 0.035
0.1 0.37 0.057 0.11
1 1.17 0.18 0.35
10 3.7 0.57 1.1
100 11.7 1.8 3.5
www.masimo.com 39 Masimo
MightySat Rx Appendix
frequency of the transmitter, where P is the maximum output power rating of the transmitter
Recommended Separation Distance Between Portable and Mobile RF Communication
Equipment and the ME Equipment
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Symbols
The following symbols may appear on the product or product labeling:
Symbol Description Symbol Description
Follow instructions for
use
Mark of conformity to European medical
device directive 93/42/EEC
Protection from ingress
of particulates > than
12.5 mm and ingress
from spraying water
No parameter alarms
Non-Sterile
Federal Communications Commission (FCC)
Licensing
Type BF applied part
Polypropylene
Separate collection for
electrical and electronic
equipment (WEEE)
Body weight
Storage temperature
range
Caution
Not made with natural rubber latex
Storage humidity limitation
www.masimo.com 40 Masimo
MightySat Rx Appendix
Symbol Description Symbol Description
Wireless features can be
used in member states
with the restriction of
indoor use in France Class 2 wireless device
Instructions/Directions for Use/Manuals are
available in electronic format
@http://www.Masimo.com/TechDocs
Note: eIFU is not available in all countries.
Citations
[1] The Masimo SET® Technology used in the MightySat™ Rx Fingertip Pulse Oximeter has been
validated for no motion accuracy in human blood studies on healthy adult male and female
volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70% to
100% SpO2 against a laboratory co-oximeter.
[2] The Masimo SET® Technology used in the MightySat™ Rx Fingertip Pulse Oximeter has been
validated for motion accuracy in human blood studies on healthy adult male and female
volunteers with light to dark pigmented skin in induced hypoxia studies while performing
rubbing and tapping motions, at 2 Hz to 4 Hz at an amplitude of 1 cm to 2 cm and a
non-repetitive motion between 1 Hz to 5 Hz at an amplitude of 2 cm to 3 cm in induced hypoxia
studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter.
[3] The Masimo SET® Technology used in the MightySat™ Rx Fingertip Pulse Oximeter has been
validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and
Masimo’s simulator with signal strengths of greater than 0.02% and transmission of greater
than 5% for saturations ranging from 70% to 100%.
[4] The Masimo SET® Technology used in the MightySat™ Rx Fingertip Pulse Oximeter has been
validated for pulse rate accuracy for the range of 25 bpm to 240 bpm in bench top testing
against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than
0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%. Pulse
rate accuracy under motion was verified by bench top testing in the range of 55 bpm to 180
bpm against a Biotek simulator using the motion preset setting.
[5] RRp performance has been clinically validated on 28 healthy, adult volunteers and 59
hospitalized adult patients. The clinical testing included non-randomized studies comparing
RRp measurements against manual, clinician-scored capnograms. The clinical testing on
hospitalized adult patients was conducted using convenience sampling and did not necessarily
include all patient conditions found in hospitals and hospital-type settings. The clinical testing
results may not be generalized to all patient conditions. RRp performance was validated across
the entire range of 4-70 RPM through bench testing.
www.masimo.com 41 Masimo
Cleaning, Disinfecting, and Service
Cleaning and Disinfecting MightySat Rx
WARNING: Before cleaning, read Cleaning and Service Warnings on page 11.
WARNING: Before cleaning, make sure the device is off and is not applied to a finger.
CAUTION: Thoroughly clean and low level disinfect the MightySat Rx before applying it to on
a new patient.
Note: Before cleaning, remove the batteries and make sure the battery cover is re-attached
correctly.
To clean the MightySat Rx, follow the instructions below:
• Wipe the outer surfaces using a dampened soft cloth twice with one of the
recommended cleaning solutions listed below, or until the surfaces are free of any
visible residue.
Note: Pay particular attention to cracks, crevices, and hard to reach areas of the
device.
• Repeat the above cleaning step using a fresh wipe.
• Allow MightySat Rx to dry thoroughly before using again.
To conduct low level surface disinfection of the MightySat Rx, follow the instructions below:
Note: Follow cleaning instructions prior to disinfecting the device.
• Visibly wet the sensor pads and outer surfaces using a soft cloth dampened with a
10% (1:10) chlorine bleach to water solution.
• Allow the solution to sit for 10 minutes on the sensor pads before wiping them
with a dry soft cloth.
• Allow the MightySat Rx to dry thoroughly before using again.
The surfaces of the MightySat Rx may be cleaned with the following:
• 70% Isopropyl Alcohol
• Cidex Plus (3.4% glutaraldehyde)
• 10% (1:10) chlorine bleach to water solution
CAUTION: To avoid permanent damage to the MightySat Rx, do not use undiluted bleach (5%
- 5.25% sodium hypochlorite) or any other cleaning solution not recommended.
Service
WARNING: Do not attempt to repair the MightySat Rx as this may cause damage to the
device and prevent it from operating properly.
If the device does not appear to be operating correctly, see Troubleshooting on page 25
section in this manual.
Note: To maintain the proper functionality of the battery compartment and avoid possible
damage from alkaline batteries that may leak, remove batteries from the device when not in
use for long periods of time.
www.masimo.com 43 Masimo
MightySat Rx Appendix
Product Support
For additional help, contact Masimo Technical Services at (949) 297-7498. Local contact
information can be found at http://service.masimo.com.
Limited Warranty
Masimo warrants to the original end-user purchaser the Masimo-branded hardware product
MightySat™ Rx Fingertip Pulse Oximeter and any software media contained in the original
packaging against defects in material and workmanship when used in accordance with
Masimo’s user manuals, technical specifications, and other Masimo published guidelines for a
period of 48 months from the original date the Product was obtained by the end-user
purchaser.
Masimo’s sole obligation under this warranty is the repair or replacement, at its option, of any
defective Product or software media that is covered under the warranty.
To request a replacement under warranty, Purchaser must contact Masimo and obtain a
returned goods authorization number so that Masimo can track the Product. If Masimo
determines that a Product must be replaced under warranty, it will be replaced and the cost of
shipment covered. All other shipping costs must be paid by purchaser.
The above described warranty is in addition to any statutory rights provided to Purchaser
under applicable laws and regulations of the region in which the product was sold to the
extent that those rights cannot be disclaimed and are superseded by the above described
warranty to the extent permitted under applicable laws and regulations of the region in which
the product was sold.
Exclusions
The warranty does not apply to any non-Masimo branded product or any software, even if
packaged with the Product, or any Product that was: (a) not new or in its original packaging
when supplied to purchaser; (b) modified without Masimo’s written permission; (c) supplies,
devices, or systems external to the Product; (d) disassembled, reassembled, or repaired by
anyone other than a person authorized by Masimo; (e) used with other products, like new
sensors, reprocessed sensors, or other accessories, not intended by Masimo to be used with
the Product; (f) not used or maintained as provided in the operator’s manual or as otherwise
provided in its labeling; (g) reprocessed, reconditioned, or recycled; and (h) damaged by
accident, abuse, misuse, liquid contact, fire, earthquake or other external cause.
No warranty applies to any Product provided to Purchaser for which Masimo, or its
authorized distributor, is not paid; and these Products are provided AS-IS without
warranty.
Limitation of Warranty
Except as otherwise required by law or altered by the purchase agreement, the above
warranty is the exclusive warranty that applies to the Product and software media, and
Masimo does not make any other promises, conditions, or warranties regarding the
Product. No other warranty applies, express or implied, including without limitation, any
implied warranty of merchantability, fitness for a particular purpose, satisfactory quality,
or as to the use of reasonable skill and care. In so far as the above warranties cannot be
www.masimo.com 44 Masimo
MightySat Rx Appendix
disclaimed, Masimo limits the duration and remedies of the warranties to the duration
and to the remedies set forth above and as permitted by law. See the licensing terms for
the terms and conditions that apply to and Software accompanying the Product.
Additionally, Masimo will not be liable for any incidental, indirect, special, or consequential
loss, damage, or expense arising from the use or loss of use of any Products or Software. In no
event shall Masimo’s liability arising from any Product or Software (under contract, warranty,
tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or
Software. The above limitations do not preclude any liability that cannot legally be
disclaimed by contract.
Sales & End-User License Agreement
This document is a legal agreement between you (“purchaser”) and Masimo Corporation
(“Masimo”) for the purchase of this Product (“Product”) and a license in the included or
embedded Software (“Software”) except as otherwise expressly agreed in a separate contract
for the acquisition of this Product, the following terms are the entire agreement between the
parties regarding your purchase of this Product. If you do not agree to the terms of this
agreement, promptly return the entire Product, including all accessories, in their original
packages, with your sales receipt to Masimo for a full refund.
Restrictions
1. Copyright Restrictions: The Software and the accompanying written materials are
copyrighted. Unauthorized copying of the Software, including Software that has
been modified, merged, or included with other software, or the written materials is
expressly forbidden. Purchaser may be held legally responsible for any copyright
infringement that is caused or incurred by Purchaser’s failure to abide by the terms
of this Agreement. Nothing in this License provides any rights beyond those
provided by 17 U.S.C. §117.
2. Use Restrictions: Purchaser may physically transfer the Product from one location
to another provided that the Software is not copied. Purchaser may not
electronically transfer the Software from the Product to any other instrument.
Purchaser may not disclose, publish, translate, release, distribute copies of, modify,
adapt, translate, reverse engineer, decompile, disassemble, or create derivative
works based on the Software or the written materials.
3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell,
or otherwise dispose of the Product or the Software on a temporary basis.
Purchaser shall not assign or transfer this License, in whole or in part, by operation
of law or otherwise without Masimo's prior written consent; except that the
Software and all of Purchaser’s rights hereunder shall transfer automatically to any
party that legally acquires title to the Product with which this Software is included.
Any attempt to assign any rights, duties or obligations arising hereunder other
than as set forth in this paragraph shall be void.
4. U.S. Government Rights: If Purchaser is acquiring Software (including the related
documentation) on behalf of any part of the United State Government, the
following provisions apply: the Software and documentation are deemed to be
“commercial software” and “commercial computer software documentation,”
respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any
use, modification, reproduction, release, performance, display or disclosure of the
Software (including the related documentation) by the U.S. Government or any of
its agencies shall be governed solely by the terms of this Agreement and shall be
www.masimo.com 45 Masimo
MightySat Rx Appendix
prohibited except to the extent expressly permitted by the terms of this
Agreement.
Notes:
www.masimo.com 46 Masimo
Index
A
Advanced Setup and Use • 21
Appendix • 25
B
Basic Setup and Use • 17, 25, 26
Battery Life • 33
Benefits of MightySat Rx • 13
Bluetooth Connection • 22
Bluetooth LE Wireless Technology
Information • 35
Guidance and Manufacturer's
Declaration - Electromagnetic
Emissions • 36
Guidance and Manufacturer's
Declaration - Electromagnetic
Immunity • 37
L
Limitation of Warranty • 44
Limited Warranty • 44
M
Main Menu Options • 21, 22, 23
Medical Conditions • 31
MightySat Rx Features • 16
C
Citations • 41
Cleaning and Disinfecting MightySat Rx •
43
Cleaning and Service Warnings • 11, 43
Cleaning, Disinfecting, and Service • 43
Compliance • 34
Compliance Warnings • 11
Connecting to a Smart Device via
Bluetooth (Optional) • 22
D
Description • 15
Device Description • 7
Display Ranges • 26
E
Environment • 34
Exclusions • 44
G
General Warnings and Precautions • 9
Glossary • 5
N
Notes: • 19, 24, 46
P
Parts List • 15
Performance Specifications • 27
Performance Warnings • 10
Physical Characteristics • 34
Product Description • 7
Product Support • 44
Purpose of the Device (Indications for
Use) • 7
R
Recommended Separation Distances •
39
Restrictions • 45
Risks and Benefits • 13
Risks of MightySat Rx • 13
RRp Performance Specifications • 29
S
Safety Warnings • 9
www.masimo.com 47 Masimo
MightySat Rx Index
Sales & End-User License Agreement •
45
Service • 43
Specifications • 23, 26
SpO2 Performance Specifications • 27, 28
Symbols • 40
T
Troubleshooting • 18, 25, 43
U
Using the Touchpad • 16, 21, 22
www.masimo.com 48 Masimo
www.masimo.com
300162/LAB-10168A-0119
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