Masimo MightySat Rx Home Care Manual

Fingertip pulse oximeter

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Operator's manual (48 pages)

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Summary of Contents for Masimo MightySat Rx

Page 1 Home Care 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: Table Of Contents
Performance Warnings -------------------------------------------------------------------------------- 10 Cleaning and Service Warnings --------------------------------------------------------------------- 11 Compliance Warnings --------------------------------------------------------------------------------- 11 Risks and Benefits ----------------------------------------------------------------------------------------- 13 Risks of MightySat Rx --------------------------------------------------------------------------------- 13 Benefits of MightySat Rx ------------------------------------------------------------------------------ 13 Description -------------------------------------------------------------------------------------------------- 15 Parts List ------------------------------------------------------------------------------------------------- 15 MightySat Rx Features -------------------------------------------------------------------------------- 16...
Page 7: Glossary
Pulse Oximeter: A medical device that uses a sensor to indirectly measure oxygen saturation of blood and pulse rate. Quality of Service (QoS): Description or measurement of overall performance of the Bluetooth communication between MightySat Rx and the mobile device as seen by the user. www.masimo.com Masimo...
Page 9: Device Description
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: General Warnings And Precautions
WARNING: Do not use MightySat Rx near flammable gases such as anesthetics, oxygen, oxygen-enriched environments, or nitrous oxide to prevent risk of fire. WARNING: Only use the MightySat Rx to the secure it to the finger. Too much pressure to a finger can cause skin damage.
Page 12: Performance Warnings
PC and tablets, pagers, Bluetooth devices, devices with remote controls, and baby monitors. Note: The MightySat Rx display may be difficult to view when exposed to direct sunlight or bright lights.
Page 13: Cleaning And Service Warnings
WARNING: To prevent damage to MightySat Rx: • Remove batteries when the MightySat Rx will not be in use for more than 30 days • Replace both batteries at the same time to avoid mixing fully and partially charged batteries.
Page 14 MightySat Rx General Warnings and Precautions 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...
Page 15: Risks And Benefits
Risks and Benefits Before using any medical device, it is important to consult your physician and weigh the risks and benefits. The following section describes the Benefits and Risks associated with using MightySat Rx. Risks of MightySat Rx • As with all medical electrical devices, there is always a risk of electrical, mechanical, and fire hazards.
Page 17: Description
Description Parts List MightySat Rx consists of the following items: Item Description MightySat Rx Batteries Lanyard Carrying Case www.masimo.com Masimo...
Page 18: Mightysat Rx Features
MightySat Rx Description MightySat Rx Features Item Description Function Enclosure Clip Attach lanyard to the clip. Bluetooth Displays when Bluetooth is enabled on the device. Indicator (Optional) Battery Status Displays remaining battery life. Indicator Main Screen Display for measurements and indicators.
Page 19: Basic Setup And Use
Basic Setup and Use The following steps include basic setup and use for operating the MightySat Rx device. The MightySat Rx requires two alkaline AAA batteries to operate. To install batteries, follow the steps below: Note: MightySat Rx will not work if the batteries are inserted backwards.
Page 20 Note: If readings are not displayed, see Troubleshooting on page 25. CAUTION: Do not press the top of the device while on the finger. WARNING: Do not attempt to secure the MightySat Rx to the finger using additional pressure. www.masimo.com...
Page 21: Notes
MightySat Rx Basic Setup and Use The MightySat Rx turns off after removing it from the finger. Notes: www.masimo.com Masimo...
Page 23: Advanced Setup And Use
Enter the Press and hold The menu allows changes to MightySat Rx settings. Menu Screen. the Touchpad. See Main Menu Options on page 22. Navigate the Swipe left or right Switches between menu items on the Menu Screen.
Page 24: Main Menu Options
* When On, the icon is white, when Off, the icon is gray (dimmed). 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 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: Notes
On the smart device, access the Masimo Professional Health app Options. 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. Notes: www.masimo.com...
Page 27: Appendix
Low battery • Re-orient batteries • Environmental influences • Replace with new batteries • Relocate device • Contact Masimo Technical Services • • No battery Replace with new batteries Device display does not turn on • • Incorrect battery Re-orient batteries orientation •...
Page 28: Specifications
Contact Masimo Technical Services • • Bluetooth LE not Confirm Bluetooth LE is on Measurement does not connected for the MightySat Rx and the display on the smart device smart device using optional Bluetooth • Compatible app not • installed on smart...
Page 29 MightySat Rx Appendix Performance Specifications SpO2 Accuracy Condition Range Population No Motion [1] 70% to 100% Adults, Pediatrics 2% Motion [2] 70% to 100% Adults, Pediatrics 3% Low perfusion [3] 70% to 100% Adults, Pediatrics 2% See the SpO2 Performance Specifications on page 28 for additional SpO2 accuracy information.
Page 30 Appendix 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% – 100% 1.08% 80% –...
Page 31 MightySat Rx Appendix Figure 1: MightySat™ Rx Fingertip Pulse Oximeter (A 70-100%) 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.
Page 32 MightySat Rx Appendix 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 33 MightySat Rx Appendix 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 34 MightySat Rx Appendix Coronary Disease Musculoskeletal and Connective Tissue Hypertension Degenerative Joint Disease Endocrine/Metabolic Dupuytrens Contracture (Right Hand) Diabetes (Type I or II) Osteoarthritis Neoplasm Hyperlipidemia Hypomagnesemia Lipoma Hypothyroidism Malignant Tumor Neurological Morbid Obesity Gastrointestinal Bilateral Hand Tremors Acid Reflux...
Page 35 MightySat Rx Appendix Rectocele Asthma 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...
Page 36 MightySat Rx Appendix Environment Item Description Operating Temperature 5°C to 40°C (41°F to 104°F) Storage Temperature -40°C to 70°C (-40°F to 158°F) Operating Humidity 10% to 95% non-condensing Storage Humidity 10% to 95% non-condensing Atmospheric pressure 540 mBar to 1060 mBar...
Page 37 MightySat Rx Appendix 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 Type BF applied part electric shock Mode of Operation Continuous Operation Degree of Protection from IP23, Protection from ingress of particulates >...
Page 38 MightySat Rx Appendix Radio Compliance 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 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.
Page 39 MightySat Rx Appendix 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 40 MightySat Rx Appendix 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 41 MightySat Rx Appendix 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 42 MightySat Rx Appendix 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 43 Class 2 wireless device 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 45: Cleaning, Disinfecting, And Service
- 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. If the device does not appear to be operating correctly, see Troubleshooting on page 25 section in this manual.
Page 46 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 47 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 48: Notes
MightySat Rx Appendix prohibited except to the extent expressly permitted by the terms of this Agreement. Notes: www.masimo.com Masimo...
Page 49: Index
Limitation of Warranty • 44 Limited Warranty • 44 Basic Setup and Use • 17, 25, 26 Battery Life • 33 Benefits of MightySat Rx • 13 Main Menu Options • 21, 22, 23 Bluetooth Connection • 22 Medical Conditions • 31 Bluetooth LE Wireless Technology Information •...
Page 50 MightySat Rx Index Sales & End-User License Agreement • Service • 43 Specifications • 23, 26 SpO2 Performance Specifications • 27, 28 Symbols • 40 Troubleshooting • 18, 25, 43 Using the Touchpad • 16, 21, 22 www.masimo.com Masimo...
Page 52 300162/LAB-10168A-0119...

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