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Summary of Contents for Masimo MightySat Medical
- Page 1 User's Manual ® MightySat Medical Pulse Oximeter...
- Page 3 Read these instructions before use. If you have a serious problem, please contact your competent authority and Masimo. Masimo Corporation 52 Discovery Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005, CAN/CSA C22.2 No.
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Page 5: Table Of Contents
Using the Touchpad ................................................13 Main Menu Options ................................................13 Connecting to a Smart Device via Bluetooth (Optional) ..................................... 14 Appendix ....................................................15 Troubleshooting ................................................... 15 Specifications ..................................................15 Cleaning, Disinfecting, and Service ............................................ 22 Index ......................................................25 Masimo Corporation www.masimo.com... -
Page 6: Glossary
The MightySat Medical Pulse Oximeter is for self-monitoring of SpO and pulse rate by individuals 18 years and older. ® Key features available: Masimo SET technology for SpO and pulse rate in no motion and low perfusion. ® Bluetooth LE for the wireless connection to smart devices. -
Page 7: Self-Monitoring Do's And Do Not's
WARNING: Do not self-diagnose or self-medicate based on the measurements. Always consult your doctor. WARNING: See Risk and Benefit section for information on limitations and ways to get the most accurate readings. WARNING: MightySat is not intended to be used as an apnea monitor. Masimo Corporation www.masimo.com... -
Page 8: Cleaning And Service Warnings
Remove batteries when not in use for more than 30 days Replace both batteries at the same time to avoid mixing fully and partially charged batteries. Use only AAA alkaline batteries. WARNING: Dispose of battery according to local laws. Masimo Corporation www.masimo.com... -
Page 9: Compliance Warnings
Risks and Benefits Compliance Warnings WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment. WARNING: The frequency bands of this device (2.4 GHz and 5.15 to 5.25 GHz) are only for indoor use, in accordance with international telecommunication requirements. - Page 10 Health conditions affecting how oxygen is carried in your blood (e.g., sickle cell, severe anemia). Poor blood circulation. Presence of blood components not able to carry oxygen (e.g., elevated carbon monoxide levels in your blood, recent tobacco use). Age and medical history. Masimo Corporation www.masimo.com...
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Page 11: Description
MightySat ® Medical Description Description Parts List These items should be included with your MightySat: Item Description MightySat Batteries Lanyard Carrying Case Masimo Corporation www.masimo.com... -
Page 12: Mightysat Features
For more reliable SpO values, use a SpO value with a taller SIQ line and a higher Pi value that is above 0.25. Touchpad User interface for settings (see Using the Touchpad on page 13 in this manual). Masimo Corporation www.masimo.com... -
Page 13: Basic Setup And Use
Check the fit on the finger by making sure the finger can cover the entire inside bottom pad. If your finger is too small, choose a different finger. If no finger is big enough, then the MightySat should not be used. Masimo Corporation www.masimo.com... - Page 14 Shortness of breath, difficult breathing, or a cough that gets worse Restlessness and discomfort Chest pain or tightness Fast or racing pulse rate The MightySat turns off after removing it from the finger. Masimo Corporation www.masimo.com...
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Page 15: Advanced Setup And Use
For connection with a smart device. Enables or disables Bluetooth LE. On or Off * (Optional) Hardware and software information about the device. Serial number; software version; Bluetooth LE Mac About Address * When On, the icon is white, when Off, the icon is gray (dimmed). Masimo Corporation www.masimo.com... -
Page 16: Connecting To A Smart Device Via Bluetooth (Optional)
Bluetooth Connection The MightySat provides a Bluetooth LE connection to a smart device. The Bluetooth connection is only available with the Masimo App. Bluetooth icon will appear when connected. MightySat connects to a single device at a time to reduce risk of unauthorized access. -
Page 17: Appendix
Re-orient batteries Low battery Replace with new batteries Environmental influences Relocate device Contact Masimo Technical Services Device display does not turn on No battery Replace with new batteries Incorrect battery orientation ... - Page 18 The plot is provided to help you understand that just because you see one value on the MightySat that it will always match the value from a blood test. Figure 1 - MightySat Medical Pulse Oximeter Pulse Oximeter (A 70-100%) ® Masimo Corporation www.masimo.com...
- Page 19 75%, you might expect your SaO value to be around 70-75%. This is because the scatterplot at 75% shows more SaO values between 75-70%. Fortunately, the performance of the MightySat is similar for all subgroups. Masimo Corporation www.masimo.com...
- Page 20 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. (90g) Masimo Corporation www.masimo.com...
- Page 21 ME Equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in Group 1 CISPR 11 nearby electronic equipment. RF Emissions This device is not intended to be operated in the home environment. This device has not been evaluated for use in aircrafts. Class B CISPR 11 Masimo Corporation www.masimo.com...
- Page 22 (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. If the measured field strength Masimo Corporation www.masimo.com...
- Page 23 MR Unsafe. Not appropriate for use in MR environment (i.e.: inside the Lot Code MR magnet room) Type BF applied part Non-Sterile Not made with natural rubber latex Caution Atmospheric pressure limitation Storage temperature range No parameter alarms Storage humidity limitation Masimo Corporation www.masimo.com...
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Page 24: Cleaning, Disinfecting, And Service
70% to 100% SpO2 against a laboratory co-oximeter. [2] The MightySat Medical Pulse Oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with ®... - Page 25 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; (d) disassembled, reassembled, or repaired by anyone other than a person authorized by Masimo;...
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Page 27: Index
Main Menu Options • 13, 14 MightySat Features • 10 Parts List • 9 Performance Specifications • 15 Performance Warnings • 5 Physical Characteristics • 18 Product Support • 23 Pulse Oximetry Performance • 6 Recommended Separation Distances • 21 Masimo Corporation www.masimo.com... - Page 28 305187/LAB-12321A-0224...
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