SAR Assessment

FCC ID: QZ3OSIA2

RF Exposure Info

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FCCID_4438687

DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




                                                                                                Test report No:
                                                                                           NIE: 57186RAN.002A1


          Assessment report
          RF EXPOSURE REPORT ACCORDING TO
          FCC 47 CFR Part 2.1093
          ISED RSS-102 Issue 5:2015
          ISED RSS-102-SPR-002 Issue 1:2016
          IEEE Std C95.3-2002
           Identification of item tested                     General Medical Devices (Bone anchored sound
                                                             processor).

           Trademark                                         Cochlear


           Model and /or type reference                      Osia 2 Sound Processor


           Other identification of the product               FCC ID: QZ3OSIA2
                                                             IC: 8039C-OSIA2
                                                             HW Version: EP4
                                                             SW Version: Osia2-NPC.0.8.5
           Features                                          Bluetooth LE, Proprietary protocol 2.4 GHz ISM band,
                                                             SRD 5 MHz.

           Manufacturer                                      COCHLEAR LIMITED
                                                             1 University Avenue, Macquarie University, NSW, 2109,
                                                             Australia
           Test method requested, standard                   FCC 47 CFR Part 2.1093. Radiofrequency radiation
                                                             exposure evaluation: portable devices.
                                                             ISED RSS-102 Issue 5 (2015-03) – Radio Frequency
                                                             Exposure Compliance of Radiocommunication Apparatus
                                                             RSS-102-SPR-002 Issue 1 (2016-09). – Supplementary
                                                             Procedure for Assessing Compliance with RSS-102 Nerve
                                                             Stimulation Exposure Limits (3kHz a 10MHz)
                                                             IEEE Std C95.3-2002: “IEEE Recommended Practice for
                                                             Measurements and Computations of Radio Frequency
                                                             Electromagnetic Fields With Respect to Human Exposure
                                                             to Such Fields, 100 kHz–300 GHz”.

           Summary                                           IN COMPLIANCE

           Approved by (name / position & signature)         Miguel Lacave                           MIGUEL LACAVE
                                                             Antennas Lab Manager                    GARCÍA
                                                                                                     2019.08.29
                                                                                                     11:04:18 +02'00'

           Date of issue                                     2019-08-29

           Report template No                                FAN24_01

Report No: (NIE) 57186RAN.002A1                                                                                     2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




    Index
    Competences and guarantees .................................................................................................... 3
    General conditions ...................................................................................................................... 3
    Uncertainty ................................................................................................................................. 3
    Data provided by the client.......................................................................................................... 3
    Usage of samples ....................................................................................................................... 3
    Test sample description .............................................................................................................. 4
    Identification of the client............................................................................................................. 4
    Testing period and place ............................................................................................................. 4
    Document history ........................................................................................................................ 4
    Environmental conditions ............................................................................................................ 4
    Used instrumentation .................................................................................................................. 4
    General description of the device under evaluation ..................................................................... 5
    Assessment summary................................................................................................................. 6
    Appendix A: FCC RF Exposure................................................................................................... 7
         FCC SAR test exclusion considerations ................................................................................. 8
         FCC RF Exposure evaluation ............................................................................................... 10
         FCC Evaluation Results ....................................................................................................... 11
    Appendix B: ISED RF Exposure................................................................................................ 14
         ISED SAR test exclusion considerations .............................................................................. 15
         ISED RF Exposure evaluation .............................................................................................. 16
         ISED Evaluation results ........................................................................................................ 17
    Appendix C: Photographs ......................................................................................................... 20




 Report No: (NIE) 57186RAN.002A1                                      Page 2 of 23                                                            2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




Competences and guarantees
    In order to assure the traceability to other national and international laboratories, DEKRA has a calibration and
    maintenance program for its measurement equipment.
    DEKRA guarantees the reliability of the data presented in this report, which is the result of the measurements
    and the tests performed to the item under test on the date and under the conditions stated on the report and, it
    is based on the knowledge and technical facilities available at DEKRA at the time of performance of the test.
    DEKRA is liable to the client for the maintenance of the confidentiality of all information related to the item under
    test and the results of the test.
    The results presented in this Assessment Report apply only to the particular item under test established in this
    document.
    IMPORTANT: No parts of this report may be reproduced or quoted out of context, in any form or by any means,
    except in full, without the previous written permission of DEKRA.


General conditions
         1. This report is only referred to the item that has undergone the assessment.
         2. This report does not constitute or imply on its own an approval of the product by the Certification Bodies
            or competent Authorities.
         3. This document is only valid if complete; no partial reproduction can be made without previous written
            permission of DEKRA.
         4. This assessment report cannot be used partially or in full for publicity and/or promotional purposes
            without previous written permission of DEKRA and the Accreditation Bodies.


Uncertainty
    Uncertainty (factor k=2) was calculated according to the DEKRA internal document PODT000.


Data provided by the client
    The Cochlear Osia System uses bone conduction to transmit sounds to the cochlear (inner ear) with the
    purpose of enhancing hearing. The Osia 2 Sound Processor is intended to be used as a part of the Cochlear
    Osia System to pick up surrounding sound and transfer it to the implant through a digital inductive link.
    DEKRA declines any responsibility with respect to the information provided by the client and that may affect the
    validity of results.


Usage of samples
    Samples under test have been selected by: the Client.
    Sample M/01 is composed of the following elements:

        Control Nº                      Description                Model          Serial Nº         Date of reception

       57186B/001              General Medical Devices         Osia 2 Sound   1170020010597            2018/11/19
                                (Bone anchored sound            Processor
                                     processor)

         1. Sample M/01 has undergone the test(s) specified in subclause “Test method requested”.




 Report No: (NIE) 57186RAN.002A1                             Page 3 of 23                                      2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456



Test sample description
    The test sample consists of a bone anchored sound processor, which uses bone conduction to transmit sounds
    to the cochlea (inner ear) with the purpose of enhancing hearing.


Identification of the client
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Konstruktionsvägen 14, 43533 Mölnlycke, SWEDEN


Testing period and place
       Test Location               DEKRA Testing and Certification S.A.U.
         Date (start)              2019-01-30
        Date (finish)              2019-01-30


Document history
   Report number                     Date                                             Description
    57186RAN.002                 2019-01-30           First release
  57186RAN.002A1                 2019-08-29           Second release. Corrected typo in cover page related to FCC standard name



Environmental conditions
    The following limits were not exceeded during the tests:


                Temperature                                            Min. = 15 ºC
                                                                       Max. = 35 ºC
                Relative humidity                                      Min. = 30 %
                                                                       Max. = 60 %


Used instrumentation
                                                                                      Last Cal. date   Cal. due date
           1.     PMM Magnetic and Electromagnetic field meter 8051                     2018/02          2020/02
           2.     PMM Magnetic Field Probe BA04                                         2018/02          2020/02
           2.     Lumiloop GMBH LSProbe 1.2                                             2017/09          2019/09
           3.     Low Dielectric Tripod Manfrotto H-491009-01                               -                -




 Report No: (NIE) 57186RAN.002A1                                      Page 4 of 23                                      2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




General description of the device under evaluation
    The test sample consists of a bone anchored sound processor, which uses bone conduction to transmit sounds
    to the cochlea (inner ear) with the purpose of enhancing hearing. It supports Bluetooth Low Energy, Proprietary
    protocol in 2.4 GHz ISM band and SRD 5 MHz.
    According to the manufacturer, during its normal use, the separation distance between the device and the body
    of nearby users will be 0 cm.
    The equipment specifications for Bluetooth LE and Proprietary 2.4 GHz declared by the manufacturer are:


                                                                      Max.       Max.     Maximum
                                   Frequency
                                             Technology             RF output   Antenna    E.I.R.P.
                                     (MHz)
                                                                   power (dBm) gain (dBi)  (dBm)
                                   2402-2480 Bluetooth LE                0.0         -1.7    -1.7
                                   2402-2480 Proprietary                 0.0         -1.7    -1.7
                                                         Table 1: Equipment specifications


    The equipment also supports SRD at 5 MHz, which needs field testing as part of the RF Exposure assessment.
    See test results in Appendix A and B of this document.




 Report No: (NIE) 57186RAN.002A1                                   Page 5 of 23                          2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




Assessment summary

                                                 Radiofrequency radiation exposure limits

                                          FCC 47 CFR § 2.1093 & ISED RSS -102 Issue 5:2015

                Band                                                                          VERDICT
                                            Technology                               Band
                (MHz)                                                                        (Pass/Fail)
                  5.0                          SRD                               LF Band        Pass
                 2450                      Bluetooth LE                            ISM          Pass
                 2450                       Proprietary                            ISM          Pass
                                                             Table 2: Assessment summary




 Report No: (NIE) 57186RAN.002A1                                      Page 6 of 23                         2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




      Appendix A: FCC RF Exposure




 Report No: (NIE) 57186RAN.002A1                             Page 7 of 23   2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




FCC SAR test exclusion considerations
   As stated by the FCC (47 CFR §2.1093), human exposure to RF emissions from portable devices, which are
   defined as transmitting devices to be used so that the radiating structure(s) of the device is/are within 20
   centimeters of the body of the user, must be evaluated with respect to the FCC-adopted limits for SAR.
   According to FCC OET KDB 447498 D01 General RF Exposure Guidance:
   Unless specifically required by the published RF exposure KDB procedures, standalone 1-g head or body and
   10-g extremity SAR evaluation for general population exposure conditions, by measurement or numerical
   simulation, is not required when the corresponding SAR Test Exclusion Threshold condition is satisfied.
   - For distances ≤ 50 mm
   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
   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 is applied to determine SAR test exclusion.
   Approximate SAR Test Exclusion Power Thresholds at Selected Frequencies and Test Separation Distances
   are illustrated in the following Table:

                 MHz          5       10       15        20    25    30         35    40    45    50      mm
                 150         39       77       116       155   194   232        271   310   349   387
                 300         27       55        82       110   137   164        192   219   246   274
                 450         22       45        67        89   112   134        157   179   201   224
                 835         16       33        49        66    82    98        115   131   148   164   SAR Test
                 900         16       32        47        63    79    95        111   126   142   158
                 1500        12       24        37        49    61    73         86    98   110   122   Exclusion
                 1900        11       22        33        44    54    65         76    87    98   109   Threshold
                 2450        10       19        29        38    48    57         67    77    86    96     (mW)
                 3600         8       16        24        32    40    47         55    63    71    79
                 5200         7       13        20        26    33    39         46    53    59    66
                 5400         6       13        19        26    32    39         45    52    58    65
                 5800         6       12        19        25    31    37         44    50    56    62
                           Table 3: SAR Test Exclusion Thresholds for 100 MHz – 6 GHz and ≤ 50 mm




 Report No: (NIE) 57186RAN.002A1                                 Page 8 of 23                                       2019-08-29


DEKRA Testing and Certification, S.A.U.
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c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456



   - For distances > 50 mm
   For 100 MHz to 6 GHz frequencies and for test separation distances > 50 mm, the SAR test exclusion
   threshold is determined according to the following:
   1) [Power allowed at numeric threshold for 50 mm in table 1) + (test separation distance - 50
   mm)·(f(MHz)/150)] mW, at 100 MHz to 1500 MHz
   2) [Power allowed at numeric threshold for 50 mm in table 1) + (test separation distance - 50 mm)·10]
   mW, at > 1500 MHz and ≤ 6 GHz
   Approximate SAR test exclusion power thresholds at selected frequencies and test separation distances are
   illustrated in the following table

 MHz       50       60       70     80      90       100      110     120   130     140       150      160     170    180    190          mm
  100      474     481      487     494     501      507      514     521   527     534       541      547     554    561    567
  150      387     397      407     417     427      437      447     457   467     477       487      497     507    517    527
  300      274     294      314     334     354      374      394     414   434     454       474      494     514    534    554
  450      224     254      284     314     344      374      404     434   464     494       524      554     584    614    644
  835      164     220      275     331     387      442      498     554   609     665       721      776     832    888    943    SAR Test
  900      158     218      278     338     398      458      518     578   638     698       758      818     878    938    998    Exclusion
 1500      122     222      322     422     522      622      722     822   922    1022      1122     1222    1322   1422   1522    Threshold
 1900      109     209      309     409     509      609      709     809   909    1009      1109     1209    1309   1409   1509      (mW)
 2450      96      196      296     396     496      596      696     796   896     996      1096     1196    1296   1396   1496
 3600      79      179      279     379     479      579      679     779   879     979      1079     1179    1279   1379   1479
 5200      66      166      266     366     466      566      666     766   866     966      1066     1166    1266   1366   1466
 5400      65      165      265     365     465      565      665     765   865     965      1065     1165    1265   1365   1465
 5800      62      162      262     362     462      562      662     762   862     962      1062     1162    1262   1362   1462
                           Table 4: SAR Test Exclusion Thresholds for 100 MHz – 6 GHz and > 50 mm

- For frequencies below 100 MHz

The following may be considered for SAR test exclusion:

   1) For test separation distances > 50 mm and < 200 mm, the power threshold at the corresponding
   test separation distance at 100 MHz in step b) is multiplied by [1 + log(100/f(MHz))]
   2) For test separation distances ≤ 50 mm, the power threshold determined by the equation in c) 1) for
   50 mm and 100 MHz is multiplied by ½

Approximate SAR test exclusion power thresholds at selected frequencies and test separation distances are
illustrated in the following table

 MHz      < 50      50       60       70       80       90      100     110     120    130     140     150     160   170    180    190     mm
 100      237      474      481      487      494      501     507      514    521     527     534     541    547    554    561    567
  50      308      617      625      634      643      651     660      669    677     686     695     703    712    721    729    738
  10      474      948      961      975      988      1001    1015     1028   1041    1055    1068    1081   1095   1108   1121   1135
                                                                                                                                           mW
   1      711      1422     1442     1462     1482     1502    1522     1542   1562    1582    1602    1622   1642   1662   1682   1702
  0.1     948      1896     1923     1949     1976     2003    2029     2056   2083    2109    2136    2163   2189   2216   2243   2269
 0.05     1019     2039     2067     2096     2125     2153    2182     2211   2239    2268    2297    2325   2354   2383   2411   2440
 0.01     1185     2370     2403     2437     2470     2503    2537     2570   2603    2637    2670    2703   2737   2770   2803   2837
                                  Table 5: SAR Test Exclusion Thresholds for frequencies < 100 MHz




 Report No: (NIE) 57186RAN.002A1                                        Page 9 of 23                                                2019-08-29


DEKRA Testing and Certification, S.A.U.
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c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




FCC RF Exposure evaluation
   According to §1.1310 Radiofrequency radiation exposure limits, paragraph (e), the limits for Maximum
   Permissible Exposure (MPE) to radiofrequency electromagnetic fields are:




   Emissions between 100 kHz to 300 kHz should be assessed versus the limits at 300 kHz in Table 1 of Section
   1.1310: 614 V/m and 1.63 A/m according to KDB 680106 D01.




 Report No: (NIE) 57186RAN.002A1                             Page 10 of 23                           2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




FCC Evaluation Results
   1. Bluetooth and Proprietary 2.4 GHz Evaluation
   The equipment specifications declared by the manufacturer for the Bluetooth Low Energy and Proprietary
   technologies are:


                                                                                           Max.             Max.
                                                                                         declared         declared
                                                                  Frequency
                                            Mode                                          output           output
                                                                    (MHz)
                                                                                          power            power
                                                                                          (dBm)             (mW)
                                      Bluetooth LE /
                                                                  2402-2480                  0.0             1.0
                                       Proprietary
                                        Table 6: Declared output power and antenna gain values


   The evaluation according to a minimum intended use distance of 5 mm will be as follow:

                                                Max Declared                  Min. Test
                                                                                               Freq.                 Test
                        Technology           Output Power (dBm)               Distance                    Result
                                                                                               (GHz)               Exclusion
                                              (dBm)      (mW)                   (mm)
                          Bluetooth               0.0              1.0             5               2.48    0.31      Pass
                         Proprietary              0.0              1.0             5               2.48    0.31      Pass
                                                             Table 7: FCC Evaluation Result

   The computed 0.31 is < 3.0, so according to KDB 447498 D01 – General RF Exposure Guidance, this mode
   qualifies for Standalone SAR test exclusion for 1-g SAR and 10-g Extremity SAR.


    As stated into FCC KDB 447498 D01 General RF Exposure Guidance, when standalone SAR test exclusion
    applies to an antenna that transmits simultaneously with other antennas, standalone SAR must be
    estimated according to following to determine simultaneous transmission SAR test exclusion:

         (max. power of channel, including tune-up tolerance, mW)/(min. test separation distance,
    mm)]·[√f(GHz)/x] W/kg for test separation distances ≤ 50 mm; where x = 7.5 for 1-g SAR and x= 18,75
                                           for 10-g extremity SAR.

    When the min. test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test
    exclusion:

                                                          Estimated SAR
                                           Max. Output Power    Min. separation
                                                                                                          Freq.      Estimated
                       Protocol                                    distance
                                           (dBm)       (mW)                                               (GHz)       1-g SAR
                                                                     (mm)
                      Bluetooth /
                                              0.0                 1.0                    5                 2.48        0.042
                      Proprietary
                                                                Table 8: Estimated SAR

    The Estimated 1-g SAR value is 0.042 W/kg. According to FCC Ҥ2.1093 Radiofrequency radiation
    exposure evaluation: portable devices”, the limit for 1-g SAR is 1.6 W/kg.




 Report No: (NIE) 57186RAN.002A1                                         Page 11 of 23                                           2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456



   2. 5MHz SRD Evaluation
   Measurements of external H and E fields have been performed from each device side, using the equipment
   listed in the “Used Instrumentation” paragraph of this document. A test separation distance of 0 cm was set for
   the measurements using a commercial sample provided by the manufacturer:



                                         Top
                                                                   Front



          Left                                                      Right




            Back                       Bottom



                                                             Figure 9: Measurement setup


   The maximum measured values for this transmitting technology are listed in the following tables:

             Frequency                      H-Field measurements [A/m]                          Max     Limit     %
                                                                                                                        Verdict
                (MHz)            Top       Bottom Left Right Front                    Back     [A/m]    [A/m]   Limit
                 5.0            0.010       0.000    0.010 0.000 0.125                0.075    0.125    0.978   13.29     Pass
                                                     Table 10: H-field measurement values

              Frequency                     E-Field measurements [V/m]                         Max      Limit     %
                                                                                                                        Verdict
                 (MHz)           Top       Bottom Left Right Front                   Back     [V/m]    [V/m]    Limit
                  5.0            2.12        2.46    1.88 2.32    4.34               7.19      7.19    368.40   1.95     Pass
                                                    Table 11: E-field measurements values

   All H-Field and E-Field values are in compliance to values shown into §1.1310, paragraph (e), “Table 1: limits
   for Maximum Permissible Exposure (MPE).




 Report No: (NIE) 57186RAN.002A1                                     Page 12 of 23                                                2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456



   3. Multiple frequencies assessment
   When multiple sources are introduced into an environment, it becomes necessary to address the sources
   interdependently, since each source will contribute some percentage of the maximum exposure toward the
   total exposure. The sum of the ratios of the exposure from each source to the corresponding maximum
   exposure for the frequency of each source must be evaluated.

   The exposure complies with the maximum permissible exposure if the sum of the ratios is less than unity:

                                                              n
                                                                       Exp i
                                                                                  <1
                                                             i 1    Limit     i


   Where
   Expi is the measured/calculated exposure value of each source;
   Limiti is the applicable limit of each source.


   The device under evaluation is able to transmit simultaneously using SRD 5 MHz and Bluetooth LE /
   Proprietary 2.4 GHz, therefore the worst case multiple frequencies calculation will be as follow:

                                            0.042   0.125
                                                  +       = 0.026 + 0.128 = 0.154 < 1 Limit
                                             1.6    0.978




 Report No: (NIE) 57186RAN.002A1                                    Page 13 of 23                        2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




      Appendix B: ISED RF Exposure




 Report No: (NIE) 57186RAN.002A1                             Page 14 of 23   2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




ISED SAR test exclusion considerations
   According to “RSS-102 Issue 5 (2015-03) – Radio Frequency Exposure Compliance of Radiocommunication
   Apparatus (All Frequency Bands)”, paragraph “2.5.1 Exemption Limits for Routine Evaluation – SAR
   Evaluation”, the device operates below the applicable output power level (adjusted for tune-up tolerance) for
   the specified separation distance defined in Table 1:




   Output power level shall be the higher of the maximum conducted or equivalent isotropically radiated power
   (e.i.r.p.) source-based, time-averaged output power. For controlled use devices where the 8 W/kg for 1 gram
   of tissue applies, the exemption limits for routine evaluation in Table 1 are multiplied by a factor of 5. For limb-
   worn devices where the 10 gram value applies, the exemption limits for routine evaluation in Table 1 are
   multiplied by a factor of 2.5. If the operating frequency of the device is between two frequencies located in
   Table 1, linear interpolation shall be applied for the applicable separation distance. For test separation
   distance less than 5 mm, the exemption limits for a separation distance of 5 mm can be applied to determine
   if a routine evaluation is required.




 Report No: (NIE) 57186RAN.002A1                             Page 15 of 23                                      2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




ISED RF Exposure evaluation
   According to RSS-102 Issue 5, Paragraph “4. Exposure Limits”, Industry of Canada has adopted the RF field
   strength limits established in Health Canada’s RF exposure guideline, Safety code 6:




 Report No: (NIE) 57186RAN.002A1                             Page 16 of 23                            2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




ISED Evaluation results
  1. Bluetooth and Proprietary 2.4 GHz Evaluation
   According to paragraph “2.5.1 Exemption Limits for Routine Evaluation – SAR Evaluation”, the exemption
   limits for the applicable separation distance have been calculated by linear interpolation for the following
   operating frequencies:


                                                                               Exemption
                                                  Frequency        Distance
                                                                                  Limits
                                                    (MHz)           (mm)
                                                                                   (mW)
                                                      2402            5            4.26
                                                      2440            5            4.05
                                                      2480            5            3.95
                                                       Table 12: ISED Exemption Limits


   The device has a transmitting antenna with a negative gain; therefore, the maximum output power has been
   used for the evaluation as a worst-case condition. For an intended use distance of 5 mm, the evaluation for
   the applicable output power levels and exemption limits for each operating frequency will be as follow:



                                                                  Max.              Max.
                                                                                               ISED
                                                                Declared          Declared
                                                Frequency                                    Exemption
                       Technology                                Output            Output                Verdict
                                                  (MHz)                                        Limits
                                                                 Power             Power
                                                                                                (mW)
                                                                 (dBm)              (mW)
                                                    2402           0.0              1.0        4.26       Pass

                         Bluetooth                  2440           0.0              1.0        4.05       Pass

                                                    2480           0.0              1.0        3.95       Pass

                                                        Table 13: ISED Evaluation Result


   As all operating frequencies comply with SAR Test Exclusion Thresholds, according to the standard “ISED
   RSS-102 Issue 5 (2015-03)”, SAR testing is not required.


   Using FCC KDB 447498 D01 General RF Exposure Guidance (see page 11 of this document), the estimated
   1-g SAR value is 0.042 W/kg. According to “RSS-102, Table 3: SAR Limits for Devices Used by the General
   Public”, the 1-g SAR limit for localized limbs is 1.6 W/kg.




 Report No: (NIE) 57186RAN.002A1                                  Page 17 of 23                                    2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456


  2. 5MHz SRD Nerve Stimulation evaluation
   According to RSS-102 Issue 5, Nerve Stimulation exposure limits shall be evaluated for transmission into the
   frequency range from 0.003 to 10 MHz. Supplementary Procedure SPR-002, Issue 1, for Radio Standards
   Specification RSS-102 sets out the general test methods to be followed when carrying out an assessment to the
   nerve stimulation exposure requirements of RSS-102 Issue 5.

   Measurements have been performed installing the device at the edge of an 80 cm tall and non-metallic
   constructed table, placing the measurement probe at a compliance distance of 0 cm between the probe edge
   and each device side that can be used to install the device, as specified into Supplementary Procedure SPR-
   002, “Annex E – E.1.1. Passively Used Table-Top Devices”, using the equipment listed in the “Used
   Instrumentation” paragraph of this document, and following the measurement method shown in paragraph
   6.6.1.1 of “Supplementary Procedure for Assessing Compliance with RSS-102 Nerve Stimulation Exposure
   Limits SPR-002”:



                                         Top
                                                                    Front



          Left                                                       Right




            Back                       Bottom



                                                             Figure 14: Measurement setup


   The maximum measured values for this transmitting technology are listed in the following tables:

             Frequency                      H-Field measurements [A/m]                         Max     Limit      %
                                                                                                                         Verdict
                (MHz)            Top       Bottom Left Right Front                   Back     [A/m]    [A/m]    Limit
                 5.0            0.010       0.000    0.010 0.000 0.125               0.075    0.125      90     0.14      Pass
                                                     Table 15: H-field measurement values

               Frequency                    E-Field measurements [V/m]                        Max     Limit      %
                                                                                                                        Verdict
                  (MHz)           Top      Bottom Left Right Front                   Back    [V/m]    [V/m]    Limit
                   5.0            7,19       3,02    2,40 2,94    5,33               9,59     9.59     83.0    11.55     Pass
                                                    Table 16: E-field measurements values

   All H-Field and E-Field values are in compliance to values shown into “Table 4: RF Field Strength Limits for
   Devices Used by the General Public” for the frequency range used by the device.




 Report No: (NIE) 57186RAN.002A1                                     Page 18 of 23                                                2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456



        1. Multiple frequencies assessment
   When multiple sources are introduced into an environment, it becomes necessary to address the sources
   interdependently, since each source will contribute some percentage of the maximum exposure toward the
   total exposure. The sum of the ratios of the exposure from each source to the corresponding maximum
   exposure for the frequency of each source must be evaluated.

   The exposure complies with the maximum permissible exposure if the sum of the ratios is less than unity:

                                                              n
                                                                       Exp i
                                                                                  <1
                                                             i 1    Limit     i


   Where
   Expi is the measured/calculated exposure value of each source;
   Limiti is the applicable limit of each source.


   The device under evaluation is able to transmit simultaneously using SRD 5 MHz and Bluetooth LE /
   Proprietary 2.4 GHz, therefore the worst case multiple frequencies calculation will be as follow:

                                             0.042   9.59
                                                   +      = 0.026 + 0.114 = 0.152 < 1 Limit
                                              1.6     83




 Report No: (NIE) 57186RAN.002A1                                    Page 19 of 23                        2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




      Appendix C: Photographs




 Report No: (NIE) 57186RAN.002A1                             Page 20 of 23   2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456


      Equipment view




      H-Field and E-Field measurement setup views

      Front




      Back




 Report No: (NIE) 57186RAN.002A1                             Page 21 of 23   2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




      Left




      Right




      Upper




 Report No: (NIE) 57186RAN.002A1                             Page 22 of 23   2019-08-29


DEKRA Testing and Certification, S.A.U.
Parque Tecnológico de Andalucía,
c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España
C.I.F. A29 507 456




      Bottom




 Report No: (NIE) 57186RAN.002A1                             Page 23 of 23   2019-08-29



Document Created: 2019-08-29 11:04:18
Document Modified: 2019-08-29 11:04:18

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