Masimo MightySat Manuel De L'utilisateur page 3

• Warning: Do not use MightySat Rx 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 Rx 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 Rx 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 Rx 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 Rx during activities where a risk of strangulation may exist (i.e. sleeping).
• Caution: Do not attempt to reprocess, recondition or recycle MightySat Rx as these processes may damage the electrical
components, potentially leading to patient harm.
• Caution: MightySat Rx 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 35°C (95°F) environment. This
was verified by measuring the skin interface temperature with MightySat Rx operating under reasonable worst-case condi-
tions.
Performance Warnings and Cautions
• Warning: MightySat Rx is not an apnea monitor and should not be used for arrhythmia analysis.
• Warning: The MightySat Rx is intended only as an adjunct device in patient assessment. It should not be used as the sole
basis for diagnosis or therapy decisions. It must be used in conjunction with clinical signs and symptoms.
• Warning: MightySat Rx does not include visual alerts or audible alarm features to support continuous monitoring. It is
intended for spot-check use only.
• Warning: SpO
is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and
2
methemoglobin (MetHb).
• Warning: Inaccurate SpO
• Improper MightySat Rx placement or alignment
• Elevated levels of COHb and MetHb: High levels of COHb or MetHb may occur with a seemingly normal SpO
vated 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 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 Rx.
• Caution: High ambient light sources, fluorescent lights, infrared heating lamps and direct sunlight can interfere with the
performance of MightySat Rx.
• Caution: To prevent interference from ambient light, ensure that MightySat Rx is properly applied. Failure to take this
precaution in high ambient light conditions may result in inaccurate or no measurements.
• Caution: When using MightySat Rx (optional Bluetooth version) with a smart device, keep both devices within the recom-
mended range of each other (see Specifications for details); moving outside of this range may cause a loss in connection
with the smart device.
• Note: The MightySat Rx 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 Rx.
• Note: The MightySat Rx display will shut off automatically if there are no readings.
Cleaning and Service Warnings and Cautions
• Warning: Use only AAA alkaline batteries.
• Warning: Alkaline 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: An operator may only perform maintenance procedures specifically described in the manual; otherwise, return
MightySat Rx for servicing.
• Caution: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean MightySat Rx. These substanc-
es affect the device's materials and instrument failure can result.
• 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 recom-
mended here because permanent damage to MightySat Rx may occur.
• Caution: Never immerse MightySat Rx in water or any other liquid solution.
readings may be caused by:
2
3
. When ele-
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