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Summary of Contents for Masimo MightySat Rx
- Page 1 MightySat™ Rx Fingertip Pulse Oximeter Operator's Manual...
- Page 3 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.
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Page 5: Table Of Contents
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 www.masimo.com Masimo... - Page 6 MightySat Rx Contents 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...
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Page 7: 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. -
Page 9: Product Description And Indications
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. -
Page 11: Safety Information, Warnings, And Cautions
• 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. -
Page 12: Performance Warnings And Cautions
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. •... - Page 13 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. •...
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Page 14: 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. •... -
Page 15: Compliance Warnings And Cautions
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. -
Page 17: Technology Overview
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... -
Page 18: Successful Monitoring For Spo2, Pr And Pi
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. -
Page 19: Citations For Pleth Variability Index (Pvi)
MightySat Rx Technology Overview Citations for Pleth Variability Index (PVI) 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. -
Page 21: Operation
Operation MightySat Rx Features ID Description Function Enclosure Clip Clip provided for ease of lanyard attachment. 2 Bluetooth Indicates when Bluetooth LE is enabled on the device. Indicator (Optional) 3 Battery Status Indicates the remaining relative life of the battery. -
Page 22: Installing The Aaa Batteries
To take readings with the MightySat Rx, follow the instruction below: Note: Before use, ensure batteries are correctly installed in the MightySat Rx. To open the MightySat Rx, squeeze the back portion of the device as shown in the image above. -
Page 23: Turning Off Mightysat Rx
The internal spring provides the correct pressure; additional pressure may cause inaccurate readings. Turning off MightySat Rx The MightySat Rx turns off automatically after removing the finger from the device in the absence of device interaction or connection to a smart device. www.masimo.com... -
Page 24: Using The Touchpad
MightySat Rx Operation Using the Touchpad The Touchpad on MightySat Rx device is located below the display screen. Note: The display is not a touch screen. Action Description Function Touch Tap and release. Action will be Select a menu item or action. -
Page 25: Navigating The Menu
MightySat Rx Operation Navigating the Menu From the Main Screen, press and hold the Touchpad to access the Main Menu. Use the Touchpad Swipe gesture to scroll through the Main Menu Options. Use the Touch gesture to select the Main Menu Option. Use the same gestures to adjust settings. -
Page 26: Connecting To A Smart Device Via Bluetooth (Optional)
MightySat Rx Operation 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. -
Page 27: Cleaning, Disinfecting, And Service
12 in this manual. 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. -
Page 28: Service
Cleaning, Disinfecting, and Service 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 26 section in this manual. -
Page 29: Product Support
Smart device Check that MightySat Rx is damaged connected to the correct smart device Contact Masimo Technical Services Product Support For additional help, contact Masimo Technical Services at (949) 297-7498. Local contact information can be found at http://service.masimo.com. www.masimo.com Masimo... -
Page 30: Limited Warranty
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. -
Page 31: Limitation Of Warranty
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. -
Page 32: Restrictions
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. -
Page 33: Specifications
Pleth Variability Index (PVI) 0% to 100% 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 Masimo... -
Page 34: Spo2 Performance Specifications
SpO2 Performance Specifications Table below provides Arms (Accuracy Root Mean Square) values measured using the ® MightySat Rx with Masimo SET Oximetry Technology in a clinical study under no motion conditions. The below Bland-Altman plot represents the correlation of the (SpO2 + SaO2)/2 versus (SpO2 - SaO2) under no motion with an upper 95% and lower 95% limits of agreement. -
Page 35: Battery Life
MightySat Rx Specifications Battery Life Item Description Operating 1.5 Volt AAA Battery (2) Battery Life *Approximately 1800 spot checks *Note: Based upon 15 hours of operation with screen brightness set to 50% a spot check of 30 seconds. Physical Characteristics... -
Page 36: Environment
MightySat Rx Specifications Radio Compliance Radio Modes Bluetooth LE 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 Environment Item Description Operating Temperature Range 5°C to 40°C Operating Humidity 10% to 95% RH Storage/Transport Temperature -40°C to 70°C... -
Page 37: Compliance
MightySat Rx Specifications 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 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... -
Page 38: Citations
Specifications Citations 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%-100% SpO2 against a laboratory co-oximeter. -
Page 39: Symbols
MightySat Rx Specifications Symbols The following symbols may be found on the product or packaging. Symbol Definition Symbol Definition Protection from ingress of particulates > Follow Instructions IP23 than 12.5 mm and ingress from spraying for Use water ETL Intertek certification. Conforms to... -
Page 40: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
MightySat Rx Specifications 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. -
Page 41: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
MightySat Rx Specifications 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. - Page 42 MightySat Rx Specifications 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.
- Page 43 MightySat Rx Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity 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.
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Page 44: Recommended Separation Distances
MightySat Rx Specifications 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... -
Page 45: Index
Citations • 36 Citations for Pleth Variability Index (PVI) • 17 Indications for Use • 7 Cleaning and Disinfecting MightySat Rx • Installing the AAA Batteries • 20, 26 Cleaning, Disinfecting, and Service • 12, Cleaning, Disinfecting, Service Warnings Limitation of Warranty • 29 and Cautions •... - Page 46 Successful Monitoring for SpO2, PR and PI • 16 Symbols • 37 Technology Overview • 15 Troubleshooting • 21, 26 Turning off MightySat Rx • 21 Using MightySat Rx • 20, 26, 27 Using the Touchpad • 19, 22 www.masimo.com Masimo...
- Page 48 38080/9121A-1115...
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