Masimo MightySat Rx Operator's Manual

Fingertip pulse oximeter

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Operator's Manual

MightySat™ Rx Fingertip Pulse

Oximeter

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Summary of Contents for Masimo MightySat Rx

Page 1 Operator's Manual MightySat™ Rx Fingertip Pulse Oximeter...
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.
Page 5 Main Menu Options ------------------------------------------------------------------------------------ 22 Connecting to a Smart Device via Bluetooth (Optional) ---------------------------------------- 23 Turning off MightySat Rx ----------------------------------------------------------------------------- 24 Cleaning, Disinfecting, and Service --------------------------------------------------------------------- 25 Cleaning and Disinfecting MightySat Rx ----------------------------------------------------------- 25 Service --------------------------------------------------------------------------------------------------- 25 Troubleshooting ---------------------------------------------------------------------------------------- 26 Product Support ---------------------------------------------------------------------------------------- 27...
Page 6 MightySat Rx Contents Environment -------------------------------------------------------------------------------------------- 38 Physical Characteristics ------------------------------------------------------------------------------ 39 Compliance --------------------------------------------------------------------------------------------- 39 Bluetooth LE Wireless Technology Information -------------------------------------------------- 40 Guidance and Manufacturer's Declaration - Electromagnetic Emissions -------------------- 41 Guidance and Manufacturer's Declaration - Electromagnetic Immunity -------------------- 42 Recommended Separation Distances -------------------------------------------------------------- 44...
Page 7 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 The Masimo MightySat™ Rx Fingertip Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments, and transport. The Masimo MightySat™ Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO ) and pulse rate (PR) for adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
Page 11 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. www.masimo.com...
Page 12 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. •...
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. •...
Page 14 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.
Page 15 MightySat Rx Safety Information, Warnings, and Cautions 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: •...
Page 17 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 SpO and pulse rate. Functional Oxygen Saturation (SpO2) The MightySat Rx is calibrated to measure and display functional oxygen saturation (SpO the amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to transport oxygen.
Page 19 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 20 MightySat Rx Technology Overview General Description for Respiration Rate (RRp) Respiration rate can be determined by the plethysmographic waveform (RRp). This method measures respirations per minute (rpm) based on plethysmographic amplitude changes that correspond to the respiratory cycle. www.masimo.com Masimo...
Page 21 Operation MightySat Rx Features ID Description Function Enclosure Clip Clip provided for ease of lanyard attachment. Bluetooth Indicates when Bluetooth LE is enabled on the device. Indicator (Optional) 3 Battery Status Indicates the remaining relative life of the battery. Indicator Display Screen Display for measurements and indicators.
Page 22 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 Operation The tip of the finger should touch the finger stop as shown in the image below. Once the MightySat Rx is correctly closed on the finger, the MightySat Rx will display readings. Note: If no readings are displayed, see Troubleshooting on page 26 in this manual.
Page 24 MightySat Rx Operation Desired Required Action Description Function Select a menu Touch and release Select an item on the Menu Screen to switch between item. the Touchpad. options or enable/disable that option. See Main Menu Options on page 22. Exit the Menu Swipe right on the Returns to the Main Screen.
Page 25 Masimo Professional Health app are the same without a delay greater than 10 seconds. Note: If the delay is greater than 10 seconds, move the MightySat Rx closer to the smart device and repeat the connection process.
Page 26 Press/select the Paired Device information. Select Forget this Device. MightySat Rx will be disconnected from the smart device. MightySat Rx will need to be paired if it is to be used with this smart device again. 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.
Page 27 CAUTION: To avoid permanent damage to the MightySat Rx, do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended. Service WARNING: Do not attempt to repair the MightySat Rx as this may cause damage to the device and prevent it from operating properly. www.masimo.com...
Page 28 Rx on page 20 in this manual) No battery Re-orient batteries Low battery Replace with new batteries Environmental influences Relocate device Contact Masimo Technical Services Device display does not No battery Replace with new batteries turn on Device damaged Contact Masimo Technical Services Batteries may be...
Page 29 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 30 Cleaning, Disinfecting, and Service Exclusions The warranty does not apply to any non-Masimo branded product or any software, even if packaged with the Product, or any Product that was: (a) not new or in its original packaging when supplied to purchaser; (b) modified without Masimo’s written permission; (c) supplies, devices, or systems external to the Product;...
Page 31 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 See the SpO2 Performance Specifications on page 32 for additional SpO2 accuracy information. Pulse Rate (PR) Condition Range Population No Motion [4] 25 bpm to 240 bpm Adults, Pediatrics 3 bpm Motion [4] 25 bpm to 240 bpm Adults, Pediatrics 5 bpm www.masimo.com Masimo...
Page 34 SpO2 Performance Specifications Table below provides A (Accuracy Root Mean Square) values measured using the MightySat ® Rx with Masimo SET Oximetry Technology in a clinical study under no motion conditions. Measured A Values Range 90% –...
Page 35 MightySat Rx Specifications The below Bland-Altman plot represents the correlation of (SpO - SaO ) versus (SpO )/2 under no motion with an upper 95% and lower 95% limits of agreement. Figure 1: MightySat™ Rx Fingertip Pulse Oximeter (A 70-100%) www.masimo.com...
Page 36 MightySat Rx Specifications RRp Performance Specifications The below Bland Altman plots represent the correlation of RRp and the reference respiration rate in three different studies, each with upper 95% and lower 95% limits of agreement. Figure 2: Bland-Altman plot of the RRp measurement with respect to the respiration rate value on a simulator (RRref) www.masimo.com...
Page 37 MightySat Rx Specifications Figure 3: Subject by subject Bland-Altman plot of the RRp measurement with respect to the respiration rate determined by clinician-scored capnograms (RRref_c) from a clinical study of healthy volunteers www.masimo.com Masimo...
Page 38 MightySat Rx Specifications Figure 4: Subject by subject Bland-Altman plot of the RRp measurement with respect to the respiration rate determined by clinician-scored capnograms (RRref_c) from a clinical study of hospitalized patients Medical Conditions Medical Conditions from clinical study of hospitalized patients...
Page 39 MightySat Rx Specifications Hypertension Degenerative Joint Disease Endocrine/Metabolic Dupuytrens Contracture (Right Hand) Diabetes (Type I or II) Osteoarthritis Neoplasm Hyperlipidemia Hypomagnesemia Lipoma Hypothyroidism Malignant Tumor Morbid Obesity Neurological Gastrointestinal Bilateral Hand Tremors Acid Reflux Neuropathy Crohn's Disease Restless Leg Syndrome...
Page 40 MightySat Rx Specifications Hematology Pneumonia Acute Blood Loss Anemia Risk of Sleep Apnea Anemia Sleep Apnea Vascular Blood Clotting Disorder/Unspecified 1 Leukocytosis Raynaud Phenomenon Sickle Cell Disease Hepatobiliary Cholelithiasis Chronic Cholecystitis Gall Stones Liver Cyst Battery Life Item Description Operating 1.5 Volt AAA Battery (2)
Page 41 MightySat Rx Specifications Item Description Operating Humidity 10% to 95% non-condensing Storage Humidity 10% to 95% non-condensing Atmospheric pressure 540 mBar to 1060 mBar Physical Characteristics Item Description 3” x 1.7” x 1.3” Dimensions (7.6 cm x 4.3 cm x 3.3 cm) Weight without Battery 0.2 lbs.
Page 42 MightySat Rx Specifications Equipment Classifications per IEC 60601-1 Degree of Protection against Type BF applied part electric shock Mode of Operation Continuous Operation Degree of Protection from IP23, Protection from ingress of particulates > than 12.5 mm Liquid Ingress and ingress from spraying water.
Page 43 MightySat Rx Specifications Radio Compliance Europe EN 300 328 EN 301 489-17 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 44 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 45 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 46 MightySat Rx Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity (a) 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.
Page 47 MightySat Rx Specifications Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the ME Equipment For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Page 48 MightySat Rx Specifications Symbol Description Symbol Description Federal Communications Identifies unit has been Commission (FCC) registered as a radio device Licensing Innovation, Science and Non-ionizing Economic Development Canada electromagnetic radiation (ISED) Warning, electricity Biohazardous Waste Not for continuous monitoring Electrostatic...
Page 49 Note: eIFU is not available in all countries. Citations [1] 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% to 100% SpO2 against a laboratory co-oximeter.
Page 50 MightySat Rx Specifications [2] The Masimo SET® Technology used in the MightySat™ Rx Fingertip Pulse Oximeter has been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies while performing...
Page 51 Declaration - Electromagnetic Immunity • 42 Citations for Pleth Variability Index (PVi) • 17 Cleaning and Disinfecting MightySat Rx • Indications for Use • 7 Cleaning, Disinfecting, and Service • 12, Installing the AAA Batteries • 20, 26 Cleaning, Disinfecting, Service Warnings and Cautions •...
Page 52 Successful Monitoring for SpO2, PR and Pi • 16 Symbols • 45 Technology Overview • 15 Troubleshooting • 21, 26 Turning off MightySat Rx • 24 Using MightySat Rx • 20, 26, 27 Using the Touchpad • 19, 21, 22 www.masimo.com Masimo...
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