Redacted version of Exhibit A

0809-EX-ST-2015 Text Documents

MC10, Inc.

2015-07-23ELS_165063

 REDACTED FOR PUBLIC INSPECTION

July 23, 2015
Federal Communications Commission
445 12"" Street, SW
Washington, DC 20554

       Re:      Request for Confidential Treatment

MC10, Inc. ("MC10") submits this application for Special Temporary Authority (the "Application")
addressing those matters which the Application is required to address under 47 CFR5.61. By separate
letter, MC10 requests confidential treatment of certain portions of Exhibit A to the Application.

Pursuant to 47 CFR 5.53 and 5.54, the "public redacted" version of Exhibit A to MC10‘s Application is
set forth in Exhibit C to the Application.


REDACTED FOR PUBLIC INSPECTION

               Exhibit C to MC10 Special Temporary Authority Application


    Detailed explanation of why the STA is needed.

   The Special Temporary Authority (STA) is required for conducting an experimental study with
   the Massachusetts General Hospital (MGH) using Proof of Concept devices designed and
   manufactured by MC10, Inc. The purpose of this study is to further the development of a novel
   experimental medical device that can assess — for patients with a certain set of
   BR1 particular, these devices will be useful for characterizing and quantifying sleep data
    from patients with ofi The Jjcarnings from this experiment
   will help drive improvements to both device hardware and software architectures, facilitating the
   pathway for the device to be released to market.

   Per its Institution Review Board (IRB) application process, MGH has requested that MC10 obtain
   an STA from the FCC for wireless devices used in experimental studies. While the MC10 device
   uses a Commercial Off—the—Shelf (COTS) System—on—Chip (SoC) radio solution, the transceiver
   system with integrated antenna is custom designed and does not currently have an associated FCC
   ID. To facilitate the execution of the study and further MC1O innovation and technology
   development, the STA represents the most effective means for completing the study in a
   reasonable time frame. Furthermore, the six month exemption the STA offers is an ample
   amount of time for MC1O to properly deploy, use, and evaluate the performance of the devices
   prior to retrieval from MGH.

   Detailed explanation on the type of operation that will be performed

   The study will involve patient volunteers who wear MC1O designed and manufactured Proof of
   Concept devices that use a Bluetooth® Low Energy (BLE) radio to transmit data to a receiver
   (e.g. PC laptop or smart device). These devices may be worn on the
   For the majority oftheir use, the devices will be advertising BLE packets with a low duty cycle
   (e.g. once every 10 seconds) to minimize radio transmission and power dissipation. No
   Personally Identifiable Information or Personal Health Information will be telemetered via the
   MC10 device. The volunteer will wear the device for MRafter which time the device
   will be returned to MC10 for data processing.

                    Table I: BLE Antenna Characteristics (simulated)
                      Antenna Frequency                    245 GHz
                        Antenna Type                 Planar trace, monopole
                      Antenna Radiation
                          Efficiency                          37%
                   Max antenna directivity                  1.8 dBi
                       Max antenna gain                    —2.51 dBi


                           Table II: Transceiver Characteristics




          ppagoree


     REDACTED FOR PUBLIC INSPECTION


                _________
            Link Budget calculation @ 2.45 GHz at max range:

                                      Pry = Pry + Gry — Itg — LBady — Lpath

                                                                              4ndf)
                                Prx = Prx + Grx =Itx — Lpoay — 2010810 (

                                            .                              Anr(10 m)(2.45 GHz)
                  PRX = 0 dBm —2.51 dBi—5 dB — 15 dB — 2010g10 (m)



                                                Pr, = —87.51dBm
         Given:
         P;, = Nominal transmit power from nRF51822—CEAA
         G;, = Antenna gain
         L, = Losses due to balun, matching network, and antenna efficiency
         LaBogy = Losses due to proximity to the body
         Lras = Path loss at 2.45 GHz
         Pr, = Received power assuming ideal, isotropic antenna

         As most current BLE radios support sensitivities better than —93 dBm, this worst case link budget
         demonstrates that the novel device, transmitting at a nominal power level of 0 dBm, will be able
         to communicate effectively with a BLE receiver system.


3.      Description of the Geographical location and environment the operation will be performed.

        The device will be used inside an MGH facility within 1 km of the main campus:

         Massachusetts General Hospital
         55 Fruit Street
         Boston, MA 02114
         NAD 83 Latitude: 42.3631°N = 42° 21‘ 47.2"N Longitude: 71.0694°W = 71° 04‘ 9.8"W

         Description of any and all associated equipment used during operation.

         The device will primarily be used with a COTS PC laptop or smart device for transmitting data.
         Telemetry will be achieved using BLE v4.0 radios. In the case of the PC laptop, the Texas
         Instruments CC2540EMK—USB evaluation module, or similar, will be used. In the case of a
         smart device, an i0S device and its integrated BLE radio will be used.

8.     Letter requesting confidentiality (if desired).

         Per CFR Title 47 0.457(d) and 0.459



Document Created: 2015-07-23 13:27:21
Document Modified: 2015-07-23 13:27:21

© 2026 FCC.report
This site is not affiliated with or endorsed by the FCC