Document 75941097-03 Issue 1

FCC ID: YOM-6960-MON

Test Report

Download: PDF
FCCID_3677734

Report on the FCC Testing of the
Monica Healthcare Ltd
Interface unit. Model: Novii System Interface Unit
POD. Model: Novii System Pod
In accordance with FCC 47 CFR Part 18
Prepared for:                  Monica Healthcare Ltd
                               Interchange 25 business Park
                               Unit 8
                               Bostocks lane
                               Nottingham
                               NG10 5QG
                               United Kingdom

FCC ID:
YOM-6960-MON (Novii Pod) YOM -6961-MON (Novii Interface Unit)

COMMERCIAL-IN-CONFIDENCE
Date: December 2017
Document Number: 75941097-03 | Issue: 01

RESPONSIBLE FOR                       NAME                                                                   DATE                               SIGNATURE

Project Management                    Clare Wright                                                           13 December 2017


Authorised Signatory                  Matthew Russell                                                        13 December 2017
Signatures in this approval box have checked this document in line with the requirements of TÜV SÜD Product Service document control rules.

ENGINEERING STATEMENT
The measurements shown in this report were made in accordance with the procedures described on test pages. All reported testing
was carried out on a sample equipment to demonstrate limited compliance with FCC 47 CFR Part 18. The sample tested was
found to comply with the requirements defined in the applied rules.

RESPONSIBLE FOR                       NAME                                                                   DATE                               SIGNATURE

Testing                               Graeme Lawler                                                          13 December 2017
FCC Accreditation
90987 Octagon House, Fareham Test Laboratory
EXECUTIVE SUMMARY
A sample of this product was tested and found to be compliant with FCC 47 CFR Part 18: 2016.



                                           DISCLAIMER AND COPYRIGHT
                                           This non-binding report has been prepared by TÜV SÜD Product Service with all reasonable skill and care. The document is confidential to the
                                           potential Client and TÜV SÜD Product Service. No part of this document may be reproduced without the prior written approval of TÜV SÜD
                                           Product Service © 2017 TÜV SÜD Product Service
                                           ACCREDITATION
                                           Our UKAS Accreditation does not cover opinions and interpretations and any expressed are outside the scope of our UKAS Accreditation.
                                           Results of tests not covered by our UKAS Accreditation Schedule are marked NUA (Not UKAS Accredited).



TÜV SÜD Product Service                         TUV SUD Ltd is a                            Phone: +44 (0) 1489 558100                    TÜV SÜD Product Service
is a trading name of TUV SUD Ltd                TÜV SÜD Group Company                       Fax: +44 (0) 1489 558101                      Octagon House
Registered in Scotland at East Kilbride,                                                    www.tuv-sud.co.uk                             Concorde Way
Glasgow G75 0QF, United Kingdom                                                                                                           Fareham
Registered number: SC215164                                                                                                               Hampshire PO15 5RL
                                                                                                                                          United Kingdom




     TÜV SÜD Product Service


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Contents
1           Report Summary .........................................................................................................................2
1.1         Report Modification Record...........................................................................................................2
1.2         Introduction....................................................................................................................................2
1.3         Brief Summary of Results .............................................................................................................3
1.4         Application Form ...........................................................................................................................4
1.5         Product Information .......................................................................................................................7
1.6         Deviations from the Standard........................................................................................................7
1.7         EUT Modification Record ..............................................................................................................7
1.8         Test Location .................................................................................................................................8
2           Test Details ..................................................................................................................................9
2.1         Field Strength of Emissions ..........................................................................................................9
3           Measurement Uncertainty ........................................................................................................17




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1          Report Summary

1.1        Report Modification Record

           Alterations and additions to this report will be issued to the holders of each copy in the form of a
           complete document.

            Issue           Description of Change                                               Date of Issue

            1               First Issue                                                         13 December 2017


                                                             Table 1

1.2        Introduction

           Applicant                                Monica Healthcare Ltd
           Manufacturer                             Monica Healthcare Ltd
           Model Number(s)                          Interface, Pod
           Serial Number(s)                         S/N: TA1763
                                                    S/N: AA5425 & AA5431
           Hardware Version(s)                      Interface Rev L
                                                    Pod V2.54
           Software Version(s)                      Interface V2.71
                                                    Pod Rev H
           Number of Samples Tested                 1 interface with 2 Pods
           Test Specification/Issue/Date            FCC 47 CFR Part 18: 2016
           Order Number                             issue 2 501559
           Date                                     30-November-2017
           Date of Receipt of EUT                   05-December-2017
           Start of Test                            05-December-2017
           Finish of Test                           05-December-2017
           Name of Engineer(s)                      Graeme Lawler
           Related Document(s)                      ANSI C63.10 (2013)
                                                    ICES-001 Issue 4 (2006)
                                                    CISPR 11 Fourth Edition (inc Amend.1 IEC:2004)
                                                    ANSI C63.4 (2014)




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1.3       Brief Summary of Results

          A brief summary of the tests carried out in accordance with FCC 47 CFR Part 18 is shown below.

           Section      Specification Clause   Test Description                                       Result   Comments/Base Standard

           Configuration and Mode: Charging
           2.1          18.305(b)              Field Strength of Emissions                            Pass     ANSI C63.10 (2013)
                                                                                                               ICES-001 Issue 4 (2006)
                                                                                                               CISPR 11 Fourth Edition (inc Amend.1
                                                                                                               IEC:2004)
           2.2          18.307                 AC Power Line Conducted Emissions                      Pass     ANSI C63.4 (2014)


                                                                                   Table 2




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1.4         Application Form

                                                       EQUIPMENT DESCRIPTION

 Model Name/Number                            Novii System Interface Unit / Novii System Pod

 Part Number                                  107-PT-001 / 107-PT-003
 Hardware Version                             Interface Rev_L / Pod Rev_H

 Software Version                             Interface v2.71 / Pod v2.54
 FCC ID (if applicable)                                     Interface: YOM-6961-MON
                                                            Pod: YOM-6960-MON

 Industry Canada ID (if applicable)                         N/A
 Technical Description (Please provide a brief              The Novii Wireless Patch System is a Maternal/Fetal monitor that records
 description of the intended use of the equipment)          Fetal heart rate, Maternal Heart Rate and Uterine Contractions from a
                                                            pregnant subject


                                                           EQUIPMENT SUPPLIED

 WPT Source
 WPT Client
 WPT System (Client and source
 designed to work exclusively together)


                                                               WPT SOURCE
               Type 1      No intelligent communication transmitted wirelessly

               Type 2      Transmission is modulated including load modulation techniques where:
                                 1.                         Fundamental is < 490 kHz and ;
                                 2.                         All emissions are > 40 dB below RSS-GEN field strength limits.
               Type 3      Neither type 1 or type 2, but uses some form of modulation to transmit intelligent communication.
 Is the device intended for us in any of the following?:

               High power WPT device (e.g charging electric vehicles)

               WPT over a distance of > 10 cm

               Medical Device
               WPT source operating at a frequency > 400 MHz
 Does the device support power management transfer?                                   Yes

 Can the source and client operate at different separation distances?                 No
 Minimum Distance:         5 mm                                     Maximum Distance         5 mm

 Does the EUT contain any other wireless modules (excluding WPT device)?              Yes

 Can the device transmit secondary frequencies?                                       Yes Bluetooth
 State Frequencies:         2402 to 2480MHz



                                                           WPT SOURCE DESIGN
               Single fixed power transfer zone – single client

               Multiple fixed power transfer zone – single client
               Multiple non-fixed power transfer zone – single client

               Multiple power transfer zone – multiples clients




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                                                                 POWER SOURCE
            AC mains                                                 State voltage
 AC supply frequency                   (Hz)
            VAC
            Max Current
            Hz
            Single phase                                                       Three phase
 And / Or
            External DC supply
            Nominal voltage                                          5V                  Max Current       2.5      A
            Extreme upper voltage                                    5.125 V
            Extreme lower voltage                                    4.875 V
 Battery
            Nickel Cadmium                                                     Lead acid (Vehicle regulated)
            Alkaline                                                           Leclanche
            Lithium                                                            Other Details:
 4.2                       Volts nominal.
 End point voltage as quoted by equipment manufacturer                             3.7            V


                                                        FREQUENCY INFORMATION
 Frequency Range                                  0.11 to 0.205       MHz
 Channel Spacing (where applicable)
 Receiver Frequency Range (if different)                to            MHz
 Channel Spacing (if different)
 Test Frequencies*                                Bottom                             MHz         Channel Number (if applicable)
                                                  Middle                             MHz         Channel Number (if applicable)
                                                  Top                                MHz         Channel Number (if applicable)
 Intermediate Frequencies                                                      MHz
 Highest Internally Generated Frequency:                                       MHz


                                                        POWER CHARACTERISTICS

 Maximum TX power                             5              W
 Minimum TX power                                            W (if variable)
 Is transmitter intended for:
 Continuous duty                                                                                                        Yes             No
 Intermittent duty                                                                                                      Yes             No
 If intermittent state DUTY CYCLE
 Transmitter ON                                     seconds
 Transmitter OFF                                    seconds




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                                                       ANTENNA CHARACTERISTICS
       Antenna connector                                                     State impedance                   Ohm
       Temporary antenna connector                                           State impedance                   Ohm
       Integral antenna                   Type                               State impedance                   dBi
       External antenna                   Type                               State impedance                   dBi


                                                      MODULATION CHARACTERISTICS
       Amplitude                                                                 Frequency

       Phase                                                                     Other (please provide details):
 Can the transmitter operate un-modulated?                                                                                 Yes           No


                                                        CLASS OF EMISSION USED

                                                 ITU designation or Class of Emission:
                                                                     1
                                                      (if applicable) 2
                                                      (if applicable) 3
 If more than three classes of emission, list separately:


                                                        BATTERY POWER SUPPLY
 Model name/number                                                        Identification/Part number

 Manufacturer                                                             Country of Origin


                                                        ANCILLARIES (If applicable)

 Model name/number                                                        Identification/Part number

 Manufacturer                                                             Country of Origin


                                                            EXTREME CONDITIONS
 Extreme test voltages (Max)         5.125 /     V                        Extreme test voltages (Mix)                            V
                                     4.2
 Nominal DC Voltage                  5/4.2       V                        DC Maximum Current                         2.5         A

 Maximum temperature                 30          °C                       Minimum temperature                        10          °C

I hereby declare that the information supplied is correct and complete.
Name: Simon Branson                                              Position held: Engineering Manager
Date: 08/12/17




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1.5        Product Information


1.5.1      Technical Description

           The Monica Novii POD is an intrapartum Maternal/Fetal Monitor that non-invasively measures and
           displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR).

           The Novii POD acquires and displays the FHR tracing from abdominal surface electrodes that pick
           up the fetal ECG (fECG) signal. Using the same surface electrodes, the POD also acquires and
           displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from
           the maternal ECG signal (mECG).

           The POD is indicated for use on women who are at >36 completed weeks, in labor, with singleton
           pregnancies, using surface electrodes on the maternal abdomen.

           The Novii Patch is an accessory to the Novii POD that connects directly to the Novii POD and
           contains the surface electrodes that attach to the abdomen. The Novii Interface is an accessory to
           the Novii POD which provides a means of interfacing the wireless output of the Novii POD to the
           transducer inputs of a Maternal/Fetal Monitor.

           The Novii Interface enables signals collected by the Novii POD to be printed and displayed on a
           Maternal/Fetal Monitor and sent on to a central network, if connected.

           The Novii Interface is the WPT transmitter and was tested with the Novii POD which is a WPT
           client only device.

1.6        Deviations from the Standard

           No deviations from the applicable test standard were made during testing.

1.7        EUT Modification Record

           The table below details modifications made to the EUT during the test programme.
           The modifications incorporated during each test are recorded on the appropriate test pages.

                                                                                                            Date Modification
            Modification State   Description of Modification still fitted to EUT   Modification Fitted By
                                                                                                            Fitted
            Serial Number: TA1763
            0                    As supplied by the customer                       Not Applicable           Not Applicable


                                                                     Table 3




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1.8        Test Location

           TÜV SÜD Product Service conducted the following tests at our Fareham Test Laboratory.

            Test Name                           Name of Engineer(s)        Accreditation

            Configuration and Mode: Charging

            Field Strength of Emissions         Graeme Lawler              UKAS

            AC Power Line Conducted Emissions   Graeme Lawler              UKAS


                                                            Table 4

           Office Address:

           Octagon House
           Concorde Way
           Segensworth North
           Fareham
           Hampshire
           PO15 5RL
           United Kingdom




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2          Test Details

2.1        Field Strength of Emissions

2.1.1      Specification Reference

           FCC 47 CFR Part 18, Clause 18.305(b)

2.1.2      Equipment Under Test and Modification State

           Interface, S/N: TA1763 - Modification State 0
           Pod, S/N: AA5425 - Modification State 0
           Pod, S/N: AA5431 - Modification State 0

2.1.3      Date of Test

           06-December-2017

2.1.4      Test Method

           This test was performed in accordance with ANSI C63.10 clause 6.3, 6.4 and 6.5.

2.1.5      Environmental Conditions

           Ambient Temperature              19.0 °C
           Relative Humidity                34.0 %

2.1.6      Test Results

           Charging

                                                                                    * RBW 10 kHz      Marker 1 [T1 ]
                                                                                    * VBW 30 kHz              76.96 dBµV/m
                                  Ref   110 dBµV/m           * Att   10 dB           SWT 5 ms            171.654778341 kHz

                                  110
                                  18_305
                                                                                                                                 A
                                  100

                           1 PK
                           MAXH
                                  90


                                                                                                                                TDF
                                  80                                            1



                                  70



                                  60

                                                                                                                                3DB
                                  50                                                                                            AC



                                  40



                                  30



                                  20


                                  10

                                  Center   171.3342655 kHz                   10 kHz/                          Span    100 kHz




                          Date: 5.DEC.2017     17:47:40




                                                                 Figure 1 - 172.526- kHz

            Frequency     QP Level at          QP Level at            QP Limit at               QP Limit at          Angle            Height (m)    Polarity
            (kHz)         3m (dBµV/m)          3m (µV/m)              3m                        3m (µV/m)
                                                                      (dBµV/m)



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           Frequency      QP Level at              QP Level at         QP Limit at           QP Limit at          Angle                Height (m)    Polarity
           (kHz)          3m (dBµV/m)              3m (µV/m)           3m                    3m (µV/m)
                                                                       (dBµV/m)
           172.526        74.85                    5527.13             102.5                 133352.14            190                  150           Face


                                     Table 5 - Field Strength of Emissions, 9 kHz to 30 MHz

          No other emissions were detected within 10 dB of the limit.

                                                                                   * RBW 1 kHz     Marker 1 [T1 ]
                                                                                   * VBW 3 kHz             37.72 dBµV/m
                                  Ref     110 dBµV/m          * Att   10 dB         SWT 145 ms        150.000000000 kHz

                                   110
                                   18_305
                                                                                                                                  A
                                   100

                           1 PK
                           MAXH
                                   90


                                                                                                                                 TDF
                                   80



                                   70



                                   60

                                                                                                                                 3DB
                                   50                                                                                            AC



                                   40                                                                                        1



                                   30



                                   20


                                   10

                                  Start    9 kHz                          14.1 kHz/                        Stop    150 kHz




                          Date: 5.DEC.2017         17:36:49




                                                               Figure 2- 9 kHz to 150 kHz

                                                                                   * RBW 10 kHz    Marker 1 [T1 ]
                                                                                   * VBW 30 kHz            76.23 dBµV/m
                                  Ref     110 dBµV/m          * Att   10 dB         SWT 100 ms        165.785256410 kHz

                                   110
                                   18_305
                                                                                                                                  A
                                   100

                           1 PK
                           MAXH
                                   90


                                                                                                                                 TDF
                                  1 80

                                                                                                                                 PS
                                   70



                                   60

                                                                                                                                 3DB
                                   50                                                                                            AC



                                   40



                                   30



                                   20


                                   10

                                  Start    150 kHz                            985 kHz/                      Stop    10 MHz




                          Date: 5.DEC.2017         18:36:58




                                                              Figure 3 - 150 kHz to 10 MHz


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                                                                                  * RBW 10 kHz   Marker 1 [T1 ]
                                                                                  * VBW 30 kHz           39.95 dBµV/m
                                   Ref       110 dBµV/m       * Att   10 dB        SWT 200 ms        10.000000000 MHz

                                       110
                                       18_305
                                                                                                                          A
                                       100

                            1 PK
                            MAXH
                                       90


                                                                                                                         TDF
                                       80



                                       70



                                       60

                                                                                                                         3DB
                                       50                                                                                AC


                                   1
                                       40



                                       30



                                       20


                                       10

                                   Start      10 MHz                          2 MHz/                     Stop   30 MHz




                           Date: 5.DEC.2017        17:34:34




                                                              Figure 4 - 10 MHz to 30 MHz

          FCC 47 CFR Part 18, Limit Clause 18.305 (b)

           Equipment                    Operating Frequency            RF Power generated        Field Strength Limit          Distance (Meters)
                                                                       by equipment              (µV/m)
                                                                       (Watts)
                                                                       Below 500                 25                            300
                                        Any ISM frequency
           Any type unless                                             500 or more               25 x                          300
           otherwise specified
           (miscellaneous).                                            Below 500                 15                            300
                                        Any non-ISM
                                        frequency                      500 or more                                             300
                                                                                                 15 x


                                                                      Table 6 - Limit Table




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2.1.7     Test Location and Test Equipment Used

          This test was carried out in Chamber 5

                                                                              Calibration
           Instrument                Manufacturer       Type No       TE No   Period        Calibration Due
                                                                              (months)

           Antenna (Active Loop,
                                     Rohde & Schwarz    HFH2-Z2       333     24            09-Dec-2018
           9kHz-30MHz)
            Antenna
           (Dish/Tripod/Adaptor,     Rohde & Schwarz    AC-008        334                   TU
           1GHz-18GHz)

           Screened Room (5)         Rainford           Rainford      1545    36            20-Dec-2017

           Turntable Controller      Inn-Co GmbH        CO 1000       1606    -             TU

           Hygrometer                Rotronic           HYGROPALM 1   2338    12            24-Oct-2018

           EMI Test Receiver         Rohde & Schwarz    ESU40         3506    12            22-Nov-2018


                                                       Table 7

          TU - Traceability Unscheduled




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          AC Power Line Conducted Emissions

2.1.8     Specification Reference

          FCC 47 CFR Part 18, Clause 18.307

2.1.9     Equipment Under Test and Modification State

          Interface, S/N: TA1763 - Modification State 0
          Pod, S/N: AA5425- Modification State 0
          Pod, S/N: AA5431- Modification State 0

2.1.10    Date of Test

          05-December-2017

2.1.11    Test Method

          The test was performed in accordance with ANSI C63.10, clause 6.2.

2.1.12    Environmental Conditions

          Ambient Temperature         19.0 °C
          Relative Humidity           34.0 %

2.1.13    Test Results

          Charging

          Applied supply voltage: 60 Hz
          Applied supply frequency: 120 V AC

           Frequency       QP Level        QP Limit   QP Margin    AV Level    AV Limit   AV Margin
           (MHz)           (dBuV)          (dBuV)     (dBuV)       (dBuV)      (dBuV)     (dBuV)
            0.150          50.1            66.0       -15.9        34.4        56.0       -21.6
            0.178          42.1            64.6       -22.5        27.1        54.6       -27.5
            0.195          42.2            63.8       -21.6        28.5        53.8       -25.3
            0.199          40.7            63.6       -22.9        27.1        53.6       -26.6
            0.218          36.0            62.9       -26.8        21.8        52.9       -31.1
            10.000         18.5            60.0       -41.5        13.2        50.0       -36.8


                                           Table 8 - Live Line Emissions Results




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                                           Figure 5 - Live Line - 150 kHz to 30 MHz




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           Frequency       QP Level          QP Limit    QP Margin    AV Level     AV Limit   AV Margin
           (MHz)           (dBuV)            (dBuV)      (dBuV)       (dBuV)       (dBuV)     (dBuV)
            0.150          51.3              66.0        -14.7        35.7         56.0       -20.3

            0.169          46.3              65.0        -18.7        32.1         55.0       -23.0
            0.188          42.7              64.1        -21.4        28.7         54.1       -25.4

            0.206          38.8              63.4        -24.6        26.4         53.4       -27.0
            0.233          40.0              62.3        -22.3        30.2         52.3       -22.1
            10.000         47.2              60.0        -12.8        47.4         50.0       -2.6


                                           Table 9 - Neutral Line Emissions Results




                                           Figure 6 - Neutral Line - 150 kHz to 30 MHz




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          FCC 47 CFR Part 18, Limit Clause 18.307(b)

           Frequency of Emission (MHz)                                  Conducted Limit (dBµV)
                                                           Quasi-Peak                             Average
           0.15 to 0.5                                      66 to 56*                             56 to 46*

           0.5 to 5                                            56                                    46

           5 to 30                                             60                                    50


          *Decreases with the logarithm of the frequency.

                                                    Table 10 - Limit Clause

2.1.14    Test Location and Test Equipment Used

          This test was carried out in EMC Chamber 5.

                                                                                           Calibration
           Instrument                Manufacturer            Type No              TE No    Period         Calibration Due
                                                                                           (months)

           Transient Limiter         Hewlett Packard         11947A               15       12             30-May-2018

           LISN (1 Phase)            Chase                   MN 2050              336      12             07-Apr-2018

           Screened Room (5)         Rainford                Rainford             1545     36             20-Dec-2017

           Hygrometer                Rotronic                HYGROPALM 1          2338     12             24-Oct-2018

           Digital Multimeter        Iso-tech                IDM-101              2895     12             20-Jul-2018

           EMI Test Receiver         Rohde & Schwarz         ESU40                3506     12             22-Nov-2018


                                                           Table 11




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3         Measurement Uncertainty

          For a 95% confidence level, the measurement uncertainties for defined systems are:

           Test Name                                       Measurement Uncertainty

           Field Strength of Emissions                     30 MHz to 1 GHz: ± 5.2 dB

           AC Power Line Conducted Emissions               150 kHz to 30 MHz, LISN, ±3.7 dB


                                                     Table 12




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Document Created: 2017-12-13 11:58:54
Document Modified: 2017-12-13 11:58:54

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