User's Manual

37633/8722A-0115
MightySat
Fingertip Pulse Oximeter
Manufacturer:
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
MightySat Fingertip Pulse Oximeter
Operator's Manual
For Sale in the USA- Not Intended for Medical Use
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.
About this Manual
Do not operate the MightySat Fingertip Pulse Oximeter without completely reading and understanding the
instructions.
Always use the MightySat 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 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 user to avoid injury to the user, 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.
Product Description and Intended Use
Product Description
The MightySat Fingertip Pulse Oximeter is a noninvasive device that measures and displays arterial oxygen
saturation (SpO2), Pulse Rate (PR), Perfusion Index (PI), and Pleth Variability Index (PVI®). The MightySat
is available for people who weigh more than 30 kg (66 lbs).
The MightySat Fingertip Pulse Oximeter is available in the following models:
Model Product Features
9700 MightySat Measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), and
Perfusion Index (PI).
9800 MightySat, Bluetooth Measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), and
Perfusion Index (PI).
Bluetooth LE radio for transfer of parameter data to a compatible smart device.
9900 MightySat, Bluetooth and PVI Measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR),
Perfusion Index (PI), and Pleth Variability Index (PVI).
Bluetooth radio for transfer of parameter data to a smart device.
Intended Use
The MightySat Fingertip Pulse Oximeter by Masimo is for use by sports and aviation users who are
interested in knowing their blood oxygenation level (SpO2), pulse rate (PR) and perfusion index (PI). The
MightySat is not intended for medical use. The MightySat can be used in a wide range of settings, including
extreme sports, and for passengers and pilots.
Safety Information, Warnings, and Cautions
Safety Warnings and Cautions
• Warning: Do not use MightySat if it appears or is suspected to be damaged.
• Warning: Do not repair, open, or modify MightySat. Injury or equipment damage could occur.
• Warning: Do not use MightySat during magnetic resonance imaging (MRI) or in an MRI
environment.
• Warning: Do not expose MightySat components to excessive moisture such as direct exposure to
rain. Excessive moisture can cause the components to perform inaccurately or fail.
• Warning: Do not place MightySat or accessories in any position that might cause it to fall on the
user.
• Warning: Electric Shock Hazard: Do not use MightySat during defibrillation.
• Warning: Do not to use device during electrosurgery.
• Warning: Do not use MightySat in the presence of flammable anesthetics or other flammable
substance in combination with air, oxygen-enriched environments, or nitrous oxide.
• Warning: Do not use tape to secure MightySat to the site; this can restrict blood flow and cause
inaccurate readings. Use of tape can cause skin damage, and/or pressure necrosis or damage the
sensor.
• Warning: Keep the oximeter away from young children. Small items such as the battery door and
battery may become choking hazards.
• Warning: When MightySat is applied for extended periods of time, the sensor site must be checked
frequently to ensure adequate circulation, skin integrity, and correct optical alignment.
• Warning: If MightySat is applied too tightly or becomes tight due to edema it will cause inaccurate
readings and can cause pressure necrosis.
• Warning: Do not use the lanyard with MightySat during activities where a risk of strangulation may
exist (i.e. sleeping).
• Caution: Do not attempt to reprocess, recondition or recycle MightySat as these processes may
damage the electrical components, potentially leading to user harm.
• Caution: Before changing batteries, make sure the device is off and is not applied to a finger.
• Caution: MightySat contains a magnet which may interfere with other devices, including
pacemakers.
• Note: The maximum skin surface temperature is measured to be less than 41°C (106°F) in a
minimum 35°C (95°F) environment. This was verified by measuring the skin interface temperature
with MightySat operating under reasonable worst-case conditions.
Performance Warnings and Cautions
• Warning: MightySat is not intended for medical use.
• Warning: MightySat is not an apnea monitor and should not be used for arrhythmia analysis.
• Warning: Do not self-diagnose or self-medicate on the basis of the measurements. Always consult
your doctor. MightySat is not intended for medical use.
• Warning: MightySat does not include visual alerts or audible alarm features to support continuous
monitoring. It is intended for spot-check use only.
• Warning: SpO2 is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
• Warning: Inaccurate SpO2 readings may be caused by:
• Improper MightySat 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.
• Users attached to a high pressure cuff
• Avoid placing the MightySat 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
• Motion artifact
• Caution: To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to MightySat.
• Caution: High ambient light sources, fluorescent lights, infrared heating lamps and direct sunlight
can interfere with the performance of MightySat.
• Caution: To prevent interference from ambient light, ensure that MightySat is properly applied.
Failure to take this precaution in high ambient light conditions may result in inaccurate or no
measurements.
• Caution: If no measurements are displayed, find a better perfused monitoring site.
• Caution: When using MightySat Model 9800 or Model 9900 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 missing, lost, and/or inaccurate data to display on the smart device.
• Note:The MightySat display may be difficult to view when exposed to direct sunlight or bright lights.
• Note: A functional tester cannot be used to assess accuracy of MightySat.
• Note: The MightySat display will shut off automatically if there are no readings.
Cleaning and Service Warnings and Cautions
• Warning: 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.
• Warning: Use only AAA alkaline batteries.
• Warning: Batteries may leak or explode if used or disposed of improperly. Remove batteries if the
device will be stored for more than 30 days.
• Warning: Do not mix fully charged and partially charged batteries at the same time. These actions
may cause the batteries to leak.
• Caution: A user may only perform maintenance procedures specifically described in the manual;
otherwise, return MightySat for servicing.
• Caution: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean
MightySat. These substances affect the device’s materials and instrument failure can result.
• Caution: Do not submerge MightySat 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 here because permanent damage to MightySat may occur.
• Caution: Never immerse MightySat in water or any other liquid solution.
Compliance Warnings and Cautions
• Caution: Disposal of Product: Comply with local laws in the disposal of the instrument and/or its
accessories, including batteries.
• Note: When using MightySat 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.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
• 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. These limits are designed to provide reasonable
protection against harmful interference in all establishments, including domestic establishments.
The Masimo Difference
From the leader in hospital pulse oximetry comes a complete pulse oximeter that is compact and portable
to help you measure blood oxygen saturation through motion and low perfusion. The MightySat Fingertip
Pulse Oximeter allows you to noninvasively track oxygen saturation (SpO2), pulse rate (PR), perfusion index
(PI), and Pleth Variability Index (PVI). The MightySat features Masimo® Signal Extraction Technology®
(SET®) technology, proven to provide accurate pulse oximetry measurements during motion and low
perfusion.
For more than 20 years, Masimo has been focused on a singular mission–to take noninvasive patient
monitoring to new sites and applications. Visit www.Masimo.com for more information about Masimo
products.
About the MightySat Technology
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).
Display Parameter Description
Functional oxygen saturation (SpO2) Functional oxygen saturation (SpO2) is the amount of oxyhemoglobin expressed as a
percentage of the hemoglobin that is available to transport oxygen.
Pulse Rate (PR) Pulse rate (PR), measured in beats per minute (BPM), is based on the optical detection of
peripheral flow pulse.
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 continuously and noninvasively obtained from a pulse oximeter.
Pleth Variability Index (PVI ) (Model 9900
only)
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%).
The utility of PVI is unknown at this time and requires further clinical studies. Technical factors
that may affect PVI include malposition and user motion.
Plethysmograph Waveform (Pleth) 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. Clinicians have attempted to utilize this waveform and its variation for assigning signal
integrity, physiological and artifactual changes such as perfusion changes, dysrhythmia, motion
artifact, and electrical interference. For this reason, accurate and reliable presentation of the
plethysmograph waveform is of importance.
Signal I.Q. Indicators
(SIQ)
The Signal I.Q.® (SIQ) provides an indicator of the assessment of the confidence in the
displayed SpO2 value. The height of the vertical line of the SpO2 SIQ provides an assessment of
the confidence in the measurement displayed. A high vertical line indicates higher confidence
in the measurement. A small vertical line indicates lower confidence in the displayed
measurement.