Fingertip Pulse Oximeter; Safety Information, Warnings, And Cautions - Masimo MightySat Manuel De L'utilisateur

MightySat® Rx

Fingertip Pulse Oximeter

Not for Sale in the USA - For Export Only
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.
Cleared Use Only: The device and related accessories have obtained CE Mark for noninvasive user 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 instructions for use or labeling.
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.
PRODUCT DESCRIPTION AND INDICATIONS
Product Description
The MightySat Rx Fingertip Pulse Oximeter is a noninvasive device that measures and displays arterial oxygen saturation
(SpO ), Pulse Rate (PR), Perfusion Index (PI), and optional Pleth Variability Index (PVI®). The MightySat Rx is available for
2
patients who weigh more than 30 kg (66 lbs).
The following key features are available for the MightySat Rx:
• Masimo SET® technology for SpO
• 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
MightySat Rx
MightySat Rx, Bluetooth
MightySat Rx, Bluetooth,
and PVI
Indications for Use
The 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
in hospitals, hospital-type facilities, mobile, and home environments.

SAFETY INFORMATION, WARNINGS, AND CAUTIONS

Safety Warnings and Cautions
• Warning: Do not use MightySat Rx if it appears or is suspected to be damaged.
• Warning: Do not repair, open, or modify MightySat Rx. Injury or equipment damage could occur.
• Warning: Do not use MightySat Rx during magnetic resonance imaging (MRI) or in an MRI environment.
• Warning: Do not expose MightySat Rx components to excessive moisture such as direct exposure to rain. Excessive mois-
ture can cause the components to perform inaccurately or fail.
• Warning: Do not place MightySat Rx or accessories in any position that might cause it to fall on the patient.
• Warning: Electric Shock Hazard: Do not use MightySat Rx during defibrillation.
• Warning: Do not to use device during electrosurgery.
O P E R AT O R ' S M A N U A L
and pulse rate monitoring in motion and low perfusion environments.
2
Measures and displays arterial oxygen saturation (SpO
Measures and displays arterial oxygen saturation (SpO
Optional Bluetooth LE radio for transfer of parameter data to a compatible smart device.
Measures and displays arterial oxygen saturation (SpO
Pleth Variability Index (PVI).
Optional Bluetooth LE radio for transfer of parameter data to a compatible smart device.
) and pulse rate (PR). The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for use with
2
FEATURES
), Pulse Rate (PR), and Perfusion Index (PI).
2
), Pulse Rate (PR), and Perfusion Index (PI).
2
), Pulse Rate (PR), Perfusion Index (PI), and optional
2
2
en
8981C-eIFU-0620