VKF-MSAT01AMightySat

37633/8722A-0115 MightySat Fingertip Pulse Oximeter Manufacturer: Masimo Corporation 40 Parker Irvine, CA 92618 USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com MightySat Fingertip Pulse Oximeter Operator's Manual For Sale in the USA- Not Intended for Medical Use 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. About this Manual Do not operate the MightySat Fingertip Pulse Oximeter without completely reading and understanding the instructions. Always use the MightySat 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 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 user to avoid injury to the user, 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 Intended Use Product Description The MightySat Fingertip Pulse Oximeter is a noninvasive device that measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), Perfusion Index (PI), and Pleth Variability Index (PVI®). The MightySat is available for people who weigh more than 30 kg (66 lbs). The MightySat Fingertip Pulse Oximeter is available in the following models: Model Product Features 9700 MightySat Measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), and Perfusion Index (PI). 9800 MightySat, Bluetooth Measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), and Perfusion Index (PI). Bluetooth LE radio for transfer of parameter data to a compatible smart device. 9900 MightySat, Bluetooth and PVI Measures and displays arterial oxygen saturation (SpO2), Pulse Rate (PR), Perfusion Index (PI), and Pleth Variability Index (PVI). Bluetooth radio for transfer of parameter data to a smart device. Intended Use The MightySat Fingertip Pulse Oximeter by Masimo is for use by sports and aviation users who are interested in knowing their blood oxygenation level (SpO2), pulse rate (PR) and perfusion index (PI). The MightySat is not intended for medical use. The MightySat can be used in a wide range of settings, including extreme sports, and for passengers and pilots. Safety Information, Warnings, and Cautions Safety Warnings and Cautions • Warning: Do not use MightySat if it appears or is suspected to be damaged. • Warning: Do not repair, open, or modify MightySat. Injury or equipment damage could occur. • Warning: Do not use MightySat during magnetic resonance imaging (MRI) or in an MRI environment. • Warning: Do not expose MightySat components to excessive moisture such as direct exposure to rain. Excessive moisture can cause the components to perform inaccurately or fail. • Warning: Do not place MightySat or accessories in any position that might cause it to fall on the user. • Warning: Electric Shock Hazard: Do not use MightySat during defibrillation. • Warning: Do not to use device during electrosurgery. • Warning: Do not use MightySat in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. • Warning: Do not use tape to secure MightySat to the site; this can restrict blood flow and cause inaccurate readings. Use of tape can cause skin damage, and/or pressure necrosis or damage the sensor. • Warning: Keep the oximeter away from young children. Small items such as the battery door and battery may become choking hazards. • Warning: When MightySat is applied for extended periods of time, the sensor site must be checked frequently to ensure adequate circulation, skin integrity, and correct optical alignment. • Warning: If MightySat is applied too tightly or becomes tight due to edema it will cause inaccurate readings and can cause pressure necrosis. • Warning: Do not use the lanyard with MightySat during activities where a risk of strangulation may exist (i.e. sleeping). • Caution: Do not attempt to reprocess, recondition or recycle MightySat as these processes may damage the electrical components, potentially leading to user harm. • Caution: Before changing batteries, make sure the device is off and is not applied to a finger. • Caution: MightySat contains a magnet which may interfere with other devices, including pacemakers. • Note: The maximum skin surface temperature is measured to be less than 41°C (106°F) in a minimum 35°C (95°F) environment. This was verified by measuring the skin interface temperature with MightySat operating under reasonable worst-case conditions. Performance Warnings and Cautions • Warning: MightySat is not intended for medical use. • Warning: MightySat is not an apnea monitor and should not be used for arrhythmia analysis. • Warning: Do not self-diagnose or self-medicate on the basis of the measurements. Always consult your doctor. MightySat is not intended for medical use. • Warning: MightySat does not include visual alerts or audible alarm features to support continuous monitoring. It is intended for spot-check use only. • Warning: SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). • Warning: Inaccurate SpO2 readings may be caused by: • Improper MightySat placement or alignment • Elevated levels of COHb and MetHb: High levels of COHb or MetHb may …

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FCC Compliance Opinion 2015-1-14 MASI0245 Information about the Applicant Grantee (Company Name) Masimo Corporation FCC Contact Person Eugene Kim Address 40 Parker City, State, Zip Irvine, CA 92618 Job Number MASI0245 Model MightySat FCC ID VKF-MSAT01A Agent Michael Clark Approval Type Original Equipment Class DTS Digital Transmission System Rule Part 15.247 Overview The MightySat is a Pulse Oximeter which contains a bluetooth radio to allow connecting to a mobile phone. It is an LCD screen based display which is finger worn and battery powered. Confidentiality requested for allowed files. Request is properly addressed and referenced. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 5/18/2015

December 16-2014 Dear Application Examiner: Masimo Corporation is submitting this application for the certification of their model MightySat Pulse Oximeter. It is an LCD screen based display finger worn, battery operated, pulse Oximeter with a patient sensor for arterial oxygen saturation, pulse rate, perfusion index. It contains a radio interface to allow Bluetooth LE wireless connection to a mobile phone. The technical reports and exhibits demonstrate compliance with FCC Part 15.247. The applicant’s radio is compliant with FCC Part 15.247. FCC ID: VKF-MSAT01A Please treat the contents of this application in a confidential manner. Your efforts in reviewing this application are greatly appreciated. Regards, Michael Clark

Request for Confidentiality Letter-FCC 12-17-2014 NWEMCTCB To whom it may concern, We hereby respectfully request that under the provision of 47 CFR 0.459 and 0.457(d) the documents listed below and attached with this application for certification be provided with confidential status.  Schematics.pdf  Operational Description.pdf  Frequency Block Diagrams.pdf Any exhibit / information for which we have requested confidentiality, but which may not be accorded such treatment by the FCC, should be returned to us. The documents listed above contain trade secrets that are treated as confidential by us. Substantial competitive harm to us could result should they be made available to the public. Sincerely, Michael Clark Engineer Senior Test R&D Instruments

FCC ID:VKF-MSAT01A IC:7362A-MSAT01A IC Model-MightySat IP23 37613-8686D-0515 YYYY LOT Assembled in Mexico 0123 Color - PMS 429U Label, MightySat, LOT Code LAB-8686D CO-021297 05/15 (1.70) ( .42” ) .024” +/- .005” Die Line Do Not Print Inspection DimensionsArtwork .05 R .099” +/- .010” YYYY LOT Assembled in Mexico FCC ID:VKF-MSAT01A IC:7362A-MSAT01A IC Model-MightySat IP23 37613-8686D-0515 YYYY LOT Assembled in Mexico 0123 Bluetooth OUS and US Sport and Aviation Bluetooth + PVI OUS Basic OUS and US Sport and Aviation Bluetooth + PVI 510K submission world wide Rx Talon - Labels and Graphics 10-21-14 Laser EtchedPhysical Label MightySat Model: XXXX XXXXA-MMYY Patents: www.masimo.com /patents.htm IP23 XXXXA-MMYY Masimo Corporation Irvine, CA 92618 USA Assembled in Mexico 3149433 0123 Patents: www.masimo.com /patents.htm Masimo Corporation Irvine, CA 92618 USA Assembled in Mexico IP23 3149433 XXXXA-MMYY Patents: www.masimo.com /patents.htm Masimo Corporation Irvine, CA 92618 USA Assembled in Mexico IP23 3149433 XXXXA-MMYY Patents: www.masimo.com /patents.htm Masimo Corporation Irvine, CA 92618 USA Assembled in Mexico IP23 3149433 XXXXA-MMYY 0123 FCC ID:VKF-xxxxxx IC-7362A-XXXXXXX IC-MightSat Model: XXXX XXXXA-MMYY MightySat 0123 FCC ID:VKF-xxxxxx IC-7362A-XXXXXXX IC-MightSat Model: XXXX XXXXA-MMYY MightySat 0123 FCC ID:VKF-xxxxxx IC-7362A-XXXXXXX IC-MightSat Model: XXXX XXXXA-MMYY MightySat MightySat TM Designed by Masimo in California IP23 0123 IP23 MightySat TM Designed by Masimo in California Bluetooth Compatible RX ONLY IP23 0123 MightySat TM Designed by Masimo in California Bluetooth Compatible 0123 IP23 MightySat TM Designed by Masimo in California Bluetooth Compatible 0123

Optimised Antennas for Wireless Devices DATA SHEET · PRODUCTS & SERVICES Small SMD Chip antenna for miniature wireless products Fractus specialises in enabling effective mobile communications. Using fractal technology, we design and manufacture optimised antennas to make your wireless devices more competitive. Our mission is to help our clients develop innovative products and accelerate their time to market through our expertise in antenna design, testing and manufacturing. Fractus ® Micro Reach Xtend TM 2.4GHz Chip Antenna Fractus ® Micro Reach Xtend™ Chip Antenna is a very small size and low cost antenna that combines reduced clearance area required within the customer PCB with its high performance and integration flexibility. This makes it ideal for small consumer electronics devices such as small wireless headsets and highly integrated multifunction mobile handsets. Taking advantage of the space-filling properties of fractals, this small monopole antenna is perfect to use within indoor (highly scattered) environment. 4.1 mm x 2 mm x 1 mm (image larger than real size) TOP BOTTOM PAT. US 7,148,850, US 7,202,822 P/N: FR05-S1-N-0-110 Product Benefits Small form factor Allows integration into space limited areas easily and efficiently with minimum clearance area. Low cost Enables product developers to reduce BoM cost increasing device competitiveness. Omnidirectional pattern Optimises device usage due to a uniform radiation pattern. Broad bandwidth Ensures robust performance when considering different plastic housing and close body proximity. Technical Features Frequency range 2.4 GHz - 2.5 GHz Average Efficiency 54.2 % Peak Gain 0.2 dB Radiation Pattern Omnidirectional VSWR < 2:1 Polarization Linear Weight (aprox.) 0.01 g Temperature -40 to + 85ºC Impedance 50 Dimensions (L x W x H) 4.1 mm x 2 mm x 1 mm . Matching Network Values Z1: Not necessary Z2. L=7.5 nH Z3: C=1.2 pF For additional information, please download the user manual from http://www.fractus.com/main/fractus/documentation or contact [email protected]. © 2011 FRACTUS, S.A. All rights reserved. Fractus and the Fractus logo are either registered trademarks or trademarks of FRACTUS, S.A. All other trademarks are the property of their respective owners. Information contained within this document is subject to change without prior notice. Optimal matching network values may vary depending on the antenna environment. Measures from the evaluation board (40 mm x20 mm x 1 mm PCB) with 2 element matching network

RF Exposure Evaluation FCC ID: VKF-MSAT01A The device is excluded from SAR evaluation and therefore deemed compliant with FCC RF exposure requirements as described below: FCC KDB 447498 D01 v05r02 Section 4.3.1 “The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR, where  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation  The result is rounded to one decimal place for comparison  3.0 and 7.5 are referred to as the numeric thresholds in the step 2 below The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion.” The device has a maximum conducted output power of 0.803 mW in the 2.4 GHz band. The EUT has an antenna gain of 0.2 dBi for a maximum EIRP of 0.84 mW. The closest spacing of the antenna to the user’s extremity is less than 5mm as the product can be hand held while transmitting. The table below shows the results of the calculation. The value of 0.248 is well below the exclusion threshold of 3.0, therefore the unit is excluded from SAR evaluation and deemed compliant with FCC RF exposure requirements. Output Power Test Separation Transmit Frequency Exclusion Threshold Specification (mW) (mm) (GHz) 0.8 5 2.402 0.248 <=3.0

This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. This Report may only be duplicated in its entirety Masimo Corporation MightySat FCC 15.247:2014 Report # MASI0245.2 NVLAP Lab Code: 200676-0 CERTIFICATE OF TEST 2014-12-10 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. Last Date of Test: December 09, 2014 Masimo Corporation Model: MightySat Radio Equipment Testing Standards Specification Method FCC 15.247:2014 ANSI C63.10:2009 KDB 558074 V3 Results Method Clause Test Description Applied Results Comments 6.2 Powerline Conducted Emissions No N/A Not required for battery powered EUT. 6.5, 6.6 Spurious Radiated Emissions Yes Pass 6.7 Spurious Conducted Emissions Yes Pass 6.7 Band Edge Compliance Yes Pass 6.9.1 Occupied Bandwidth Yes Pass 6.10.2 Output Power Yes Pass 6.11.2 Power Spectral Density Yes Pass 7.5 Duty Cycle Yes Pass Deviations From Test Standards None Approved By: Victor Ratinoff, Operations Manager REVISION HISTORY REV 2014.10.14 Revision Number Description Date Page Number 00 None ACCREDITATIONS AND AUTHORIZATIONS REV 2014.10.08 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIP / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ MEASUREMENT UNCERTAINTY TMU.2014.12.03 Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document WP 342. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) for each test is on each data sheet. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-2 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (MU) budgets for each of the tests that may be contained in this report. Test + MU - MU Frequency Accuracy (Hz) 0.0007% -0.0007% Amplitude Accuracy (dB) 1.2 dB -1.2 dB Conducted Power (dB) 0.3 dB -0.3 dB Radiated Power via Substitution (dB) 0.7 dB -0.7 dB Temperature (degrees C) 0.7°C -0.7°C Humidity (% RH) 2.5% RH -2.5% RH Voltage (AC) 1.0% -1.0% Voltage (DC) 0.7% -0.7% Field Strength (dB) 4.7 dB -4.7 dB AC Powerline Conducted Emissions (dB) 2.9 dB -2.9 dB FACILITIES REV 2014.10.08 California Labs OC01-13 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-08, MN10 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 New York Labs NY01-04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Oregon Labs EV01-12 22975 NW Evergreen Pkwy Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 9801 (425)984-6600 NVLAP NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200761-0 NVLAP Lab Code: 200630-0 NVLAP Lab Code:201049-0 NVLAP Lab Code: 200629-0 Industry Canada 2834B-1, 2834B-3 2834E-1 N/A 2834D-1, 2834D-2 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R N/A SL2-IN-E-1017 In Process SL2-IN-E-1153R VCCI A-0029 A-0109 N/A A-0108 A-0201 A-0110 PRODUCT DESCRIPTION 2014-12-10 Client and Equipment Under Test (EUT) Information Company Name: Masimo Corporation Address: 40 Parker City, State, Zip: Irvine, CA 92618 Test Requested By: Mike Clark Model: MightySat First Date of Test: November 11, 2014 Last Date of Test: December 09, 2014 Receipt Date of Samples: November 11, 2014 Equipment Design Stage: Production Equipment Condition: No Damage Information Provided by the Party Requesting t…

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photo SRE FCC (1).JPG SRE FCC (2).JPG SPURIOUS RADIATED EMISSIONS PSA-ESCI 2014.09.10 photo SRE FCC (3).JPG SRE FCC (4).JPG SPURIOUS RADIATED EMISSIONS PSA-ESCI 2014.09.10 photo SRE FCC (5).JPG SRE FCC (6).JPG SPURIOUS RADIATED EMISSIONS PSA-ESCI 2014.09.10 SPURIOUS CONDUCTED EMISSIONS XMit 2014.02.07 NORTHWEST SPURIOUS CONDUCT NweTx 2014.10.15 EMC FCC Dir Conn (1).JPG FCC Dir Conn (2).JPG SPURIOUS CONDUCTED EMISSIONS BAND EDGE COMPLIANCE XMit 2014.02.07 NORTHWEST BAND EDGE COMPLI NweTx 2014.10.15 EMC FCC Dir Conn (1).JPG FCC Dir Conn (2).JPG BAND EDGE COMPLIANCE OCCUPIED BANDWIDTH XMit 2014.02.07 NORTHWEST OCCUPIED BANDWID NweTx 2014.10.15 EMC FCC Dir Conn (1).JPG FCC Dir Conn (2).JPG OCCUPIED BANDWIDTH OUTPUT POWER XMit 2014.02.07 NORTHWEST OUTPUT POWER NweTx 2014.10.15 EMC FCC Dir Conn (1).JPG FCC Dir Conn (2).JPG OUTPUT POWER POWER SPECTRAL DENSITY XMit 2014.02.07 NORTHWEST POWER SPECTRAL D NweTx 2014.10.15 EMC FCC Dir Conn (1).JPG FCC Dir Conn (2).JPG POWER SPECTRAL DENSITY DUTY CYCLE XMit 2014.02.07 NORTHWEST DUTY CYCLE NweTx 2014.10.15 EMC FCC Dir Conn (1).JPG FCC Dir Conn (2).JPG DUTY CYCLE