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.

www.masimo.com 3 Masimo
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
www.masimo.com 4 Masimo
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

www.masimo.com 5 Masimo
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.

www.masimo.com 7 Masimo
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.

www.masimo.com 9 Masimo
Safety Information, Warnings, and
Cautions
Safety Warnings and Cautions
•WARNING: Do not use MightySat Rx during magnetic resonance imaging (MRI) or
in an MRI environment.
•WARNING: Do not place MightySat Rx or accessories in any position that might
cause it to fall on the patient.
•WARNING: Do not use MightySat Rx during defibrillation.
•WARNING: Do not use MightySat Rx during electrosurgery.
•WARNING: Do not use MightySat Rx in the presence of flammable anesthetics or
other flammable substances, oxygen-enriched environments, or nitrous oxide to
avoid the risk of explosion.
•WARNING: Only use the MightySat Rx to the secure it to the finger. Excessive
pressure to a finger can cause skin damage.
•WARNING: Check the sensor site every hour to ensure adequate circulation, skin
integrity, and sensor alignment. Skin damage, pressure necrosis, or inaccurate
readings may result.
•WARNING: Do not leave the MightySat Rx unattended around children. Small
items such as the battery door, battery, and lanyard may become choking hazards.
•WARNING: Do not use the lanyard during activities where it may become wrapped
around the neck. Strangulation may occur.
•CAUTION: Do not use the MightySat Rx near devices that are sensitive to
magnets. The magnet provided with the MightySat Rx could interfere with the
proper operation of the device.
•Note: The maximum skin surface temperature is measured to be less than 41°C
(106°F) in a 35°C (95°F) environment. This was verified by measuring the skin
interface temperature with MightySat Rx operating under reasonable worst-case
conditions.

MightySat Rx Safety Information, Warnings, and Cautions
www.masimo.com 10 Masimo
Performance Warnings and Cautions
•WARNING: MightySat Rx is not an apnea monitor and should not be used for
arrhythmia analysis.
•WARNING: MightySat Rx should not be used as the sole basis for medical
decisions. It must be used in conjunction with clinical signs and symptoms.
•WARNING: Do not use MightySat Rx for continuous monitoring. It is intended for
spot-check use only. No alarms are provided to support continuous monitoring.
•WARNING: Do not use MightySat Rx if it appears or is suspected to be damaged.
Damage to internal parts can result in no or inaccurate readings.
•WARNING: Do not repair, open, or modify MightySat Rx. Damage to internal parts
can result in no or inaccurate readings.
•WARNING: Do not use the MightySat Rx if the internal parts have been exposed to
liquids. Damage to the internal parts may result in no or inaccurate readings.
•WARNING: SpO2 is empirically calibrated in healthy adult volunteers with normal
levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).
•WARNING: Avoid the following conditions to minimize the risk of inaccurate SpO2
readings:
•Improper MightySat Rx placement or alignment
•Elevated levels of COHb and MetHb: High levels of COHb or MetHb may
occur with a seemingly normal SpO2. When elevated levels of COHb or
MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample
should be performed.
•Intravascular dyes such as indocyanine green or methylene blue
•Externally applied coloring and texture such as nail polish, acrylic nails,
glitter, etc.
•Patients attached to a high pressure cuff
•Avoid placing the MightySat Rx sensor on any extremity with an arterial
catheter or blood pressure cuff
•Elevated levels of bilirubin
•Severe anemia
•Venous congestion
•Venous pulsation
•Low arterial perfusion
•Excessive motion
•CAUTION: Properly apply and avoid using the MightySat Rx under high ambient
light sources, fluorescent lights, infrared heating lamps 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.

MightySat Rx Safety Information, Warnings, and Cautions
www.masimo.com 11 Masimo
•CAUTION: When using MightySat Rx (optional Bluetooth version) 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 (optional Bluetooth version) 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 on page 31 for details) of the Bluetooth connection. Devices that
may cause RFI include but are not limited to the following: electrocautery
equipment, diathermy equipment, other cellular telephones, wireless PC and
tablets, pagers, RFID devices, MRI, and electromagnetic security systems.
•CAUTION: Do not attempt to remanufacture, recondition, or recycle MightySat Rx
as these processes may damage the internal parts. Damage to internal parts can
result in no or inaccurate readings.
•Note: The MightySat Rx display may be difficult to view when exposed to direct
sunlight or bright lights.
•Note: Do not assess the accuracy of the MightySat Rx using a functional tester. A
functional tester should only be used to check if a unit is working properly.
•Note: The MightySat Rx display will shut off automatically if there are no readings.

MightySat Rx Safety Information, Warnings, and Cautions
www.masimo.com 12 Masimo
Cleaning, Disinfecting, Service Warnings and Cautions
•WARNING: Properly use and dispose of Alkaline batteries or they may leak or
explode.
•WARNING: Remove alkaline batteries when the MightySat Rx will not be in use for
more than 30 days to avoid damage to the device due to batteries that may leak.
•WARNING: Replace both batteries at the same time to avoid mixing fully and
partially charged batteries. These actions may cause the batteries to leak;
resulting in possible damage to the device.
•CAUTION: Use only AAA alkaline batteries. Use of non-alkaline batteries may
affect the accuracy of the battery status indicator.
•CAUTION: Only perform maintenance procedures specifically described in the
manual; otherwise, return MightySat Rx for servicing. Improper maintenance may
result in damage to the internal parts. Damage to internal parts may result in no
or inaccurate readings.
•CAUTION: Thoroughly clean and low level disinfect the MightySat Rx before
applying it to on a new patient.
•CAUTION: Do not clean MightySat Rx with any chemical other than those
specified in Cleaning, Disinfecting, and Service on page 25. These substances may
affect the device’s materials and damage internal parts.
•CAUTION: Do not submerge MightySat Rx in any cleaning solution or attempt to
sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method.
This will seriously damage the device.
•CAUTION: Do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any
cleaning solution other than those recommended in Cleaning, Disinfecting, and
Service on page 25 of this manual. Permanent damage to MightySat Rx may occur
if other unspecified solutions are used.
•CAUTION: Never submerge MightySat Rx in water or any other liquid solution this
may cause permanent damage to the MightySat Rx.

MightySat Rx Safety Information, Warnings, and Cautions
www.masimo.com 13 Masimo
Compliance Warnings and Cautions
•WARNING: Any changes or modifications not expressly approved by Masimo shall
void the warranty for this equipment and could void the user’s authority to operate
the equipment.
•CAUTION: Comply with local laws in the disposal of the instrument and/or its
accessories, including batteries.
•CAUTION: This device is not intended to be operated in the home environment.
•CAUTION: This device has not been evaluated for use in aircrafts.
•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.
•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 EN 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.

www.masimo.com 15 Masimo
Technology Overview
The following chapter contains general descriptions about parameters, measurements, and
the technology used by Masimo products.
Signal Extraction Technology® (SET®)
Masimo Signal Extraction Technology's signal processing differs from that of conventional
pulse oximeters. Conventional pulse oximeters assume that arterial blood is the only blood
moving (pulsating) in the measurement site. During patient motion, however, the venous
blood also moves, causing conventional pulse oximeters to read low values, because they
cannot distinguish between the arterial and venous blood movement (sometimes referred to
as noise).
Masimo SET®pulse oximetry utilizes parallel engines and adaptive filtering. Adaptive filters
are powerful because they are able to adapt to the varying physiologic signals and/or noise
and separate them by looking at the whole signal and breaking it down to its fundamental
components. The Masimo SET®signal processing algorithm, Discrete Saturation Transform®
(DST®), in parallel with Fast Saturation Transform (FST®), reliably identifies the noise,
isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen
saturation for display on the monitor.
Masimo SET® DST
This figure is for conceptual purposes only.
General Description for Oxygen Saturation (SpO2)
Pulse oximetry is governed by the following principles:
•Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated
blood) differ in their absorption of red and infrared light (spectrophotometry).
•The amount of arterial blood in tissue changes with your pulse
(photoplethysmography). Therefore, the amount of light absorbed by the varying
quantities of arterial blood changes as well.

MightySat Rx Technology Overview
www.masimo.com 16 Masimo
Successful Monitoring for SpO2, PR and PI
Stability of the SpO2 readings may be a good indicator of signal validity. Although stability is
a relative term, experience will provide a good feeling for changes that are artifactual or
physiological and the speed, timing, and behavior of each.
The stability of the readings over time is affected by the averaging time being used. The
longer the averaging time, the more stable the readings tend to become. This is due to a
dampened response as the signal is averaged over a longer period of time than during shorter
averaging times. However, longer averaging times delay the response of the oximeter and
reduce the measured variations of SpO2 and pulse rate.
Functional Oxygen Saturation (SpO2)
The MightySat Rx is calibrated to measure and display functional oxygen saturation (SpO2):
the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available
to transport oxygen.
Note that dyshemoglobins are not capable of transporting oxygen, but are recognized as
oxygenated hemoglobins by conventional pulse oximetry.
General Description for Perfusion Index (PI)
The Perfusion Index (PI) is the ratio of the pulsatile blood flow to the non-pulsatile or static
blood in peripheral tissue. PI thus represents a noninvasive measure of peripheral perfusion
that can be and noninvasively obtained from a pulse oximeter.
General Description for Pulse Rate (PR)
Pulse rate (PR), measured in beats per minute (BPM) is based on the optical detection of
peripheral flow pulse.
General Description for Pleth Variability Index (PVI)
The Pleth Variability Index (PVI) is a measure of the dynamic changes in the perfusion index
(PI) that occur during the respiratory cycle. The calculation is accomplished by measuring
changes in PI over a time interval where one or more complete respiratory cycles have
occurred. PVI is displayed as a percentage (0-100%).
Pleth Variability Index (PVI) may show changes that reflect physiologic factors such as
vascular tone, circulating blood volume, and intrathoracic pressure excursions.
The utility of PVI has been evaluated in clinical studies [1-11]. Technical and clinical factors
that may affect PVI include probe malposition, probe site, patient motion, skin incision,
spontaneous breathing activity, lung compliance, open pericardium, use of vasopressors or
vasodilators, low perfusion index, subject age, arrhythmias, left or right heart failure, and tidal
volume [12-14].

MightySat Rx Technology Overview
www.masimo.com 17 Masimo
Citations for Pleth Variability Index (PVI)
1. Cannesson M., Desebbe O., Rosamel P., Delannoy B., Robin J., Bastien O., Lehot
J.J. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse
Oximeter Plethysmographic Waveform Amplitude and Predict Fluid
Responsiveness in the Operating Theatre. Br J Anaesth. 2008
Aug;101(2):200-6.
2. Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on the Pulse
Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves
Fluid Management. Anesth Analg. 2010 Oct;111(4):910-4.
3. Zimmermann M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B.M., Wiesenack C.
Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to
Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing
Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4. Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. Anesth Analg.
The Ability of Pleth Variability Index to Predict the Hemodynamic Effects of
Positive End-Expiratory Pressure in Mechanically Ventilated Patients under
General Anesthesia. 2010 Mar 1;110(3):792-8.
5. Tsuchiya M., Yamada T., Asada A. Pleth Variability Index Predicts Hypotension
During Anesthesia Induction. Acta Anesthesiol Scand. 2010 May;54(5):596-602.
6. Loupec T., Nanadoumgar H., Frasca D., Petitpas F., Laksiri L., Baudouin D., Debaene
B., Dahyot-Fizelier C., Mimoz O. Pleth Variability Index Predicts Fluid
Responsiveness in Critically Ill Patients. Crit Care Med. 2011 Feb;39(2):294-9.
7. Fu Q., Mi W.D., Zhang H. Stroke Volume Variation and Pleth Variability Index to
Predict Fluid Responsiveness during Resection of Primary Retroperitoneal Tumors
in Hans Chinese. Biosci Trends. 2012 Feb;6(1):38-43.
8. Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L., Reuter D.A. J.
Prediction of Volume Responsiveness using Pleth Variability Index in Patients
Undergoing Cardiac Surgery after Cardiopulmonary Bypass. Anesth. 2012
Oct;26(5):696-701.
9. Byon H.J., Lim C.W., Lee J.H., Park Y. H., Kim H.S., Kim C.S., Kim J.T. Br. J.
Prediction of fluid Responsiveness in Mechanically Ventilated Children
Undergoing Neurosurgery. Anaesth 2013 Apr;110(4):586-91.
10. Feissel M., Kalakhy R., Banwarth P., Badie J., Pavon A., Faller J.P., Quenot JP.
Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated
Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot
Study. J Crit Care. 2013 Oct;28(5):634-9.
11. Yu Y., Dong J., Xu Z., Shen H., Zheng J. Pleth Variability Index-Directed Fluid
Management in Abdominal Surgery under Combined General and Epidural
Anesthesia. J Clin Monit Comput. 2014 Feb 21.
12. Desgranges F.P., Desebbe O., Ghazouani A., Gilbert K., Keller G., Chiari P., Robin
J.,Bastien O., Lehot J.J., Cannesson M. Br. J. Anaesth 2011 Sep;107(3):329-35.
13. Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J
Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97.
14. Takeyama M, Matsunaga A, Kakihana Y, Masuda M, Kuniyoshi T, Kanmura Y.
Impact of Skin Incision on the Pleth Variability Index. J Clin Monit Comput 2011
Aug;25(4):215-21.