Test report 75941097-01 Issue 1

FCC ID: YOM-6961-MON

Test Report

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FCCID_3677536

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 15B Prepared for: Monica Healthcare Ltd Interchange 25 business Park Unit 8 Bostocks lane Nottingham NG10 5QG United Kingdom FCC ID: Novii Interface-YOM-6961-MON, Novii Pod-YOM-6960-MON COMMERCIAL-IN-CONFIDENCE Date: December 2017 Document Number: 75941097-01 | 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 15B. The sample tested was found to comply with the requirements defined in the applied rules. RESPONSIBLE FOR NAME DATE SIGNATURE Testing Paul Joynson 13 December 2017 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 15B: 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

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE Contents 1 Report Summary .........................................................................................................................2 1.1 Report Modification Record...........................................................................................................2 1.2 Introduction....................................................................................................................................2 1.3 Brief Summary of Results .............................................................................................................3 1.4 Declaration of Build Status ............................................................................................................4 1.5 Product Information .......................................................................................................................6 1.6 Deviations from the Standard........................................................................................................6 1.7 EUT Modification Record ..............................................................................................................6 1.8 Test Location .................................................................................................................................7 2 Test Details ..................................................................................................................................8 2.1 Radiated Emissions.......................................................................................................................8 2.2 AC Power Line Conducted Emissions ........................................................................................13 3 Measurement Uncertainty ........................................................................................................17 COMMERCIAL-IN-CONFIDENCE Page 1 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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) Novii System Interface Unit (107-PT-001) Serial Number(s) Novii System Pod (107-PT-003) Interface: TA1772 Pod: AA5233 Hardware Version(s) Interface: Rev L Pod: Rev H Software Version(s) Interface: V2.71 Pod: V2.54 Number of Samples Tested 1 System Test Specification/Issue/Date FCC 47 CFR Part 15B: 2016 Order Number Issue 2 501559 Date 30-November-2017 Date of Receipt of EUT 03-December-2017 and 05-December-2017 Start of Test 03-December-2017 Finish of Test 05-December-2017 Name of Engineer(s) Paul Joynson and Graeme Lawler Related Document(s) ANSI C63.4 (2014) COMMERCIAL-IN-CONFIDENCE Page 2 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 1.3 Brief Summary of Results A brief summary of the tests carried out in accordance with FCC 47 CFR Part 15B is shown below. Section Specification Clause Test Description Result Comments/Base Standard Configuration and Mode: Interface + Pod – Standby 2.1 15.109 Radiated Emissions Pass ANSI C63.4 2.2 15.107 AC Power Line Conducted Emissions Pass ANSI C63.4 Table 2 COMMERCIAL-IN-CONFIDENCE Page 3 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 1.4 Declaration of Build Status Novii System Interface MAIN EUT Novii System Interface Unit for the Novii Wireless Patch MANUFACTURING DESCRIPTION System MANUFACTURER Monica Healthcare Ltd MODEL NAME/NUMBER Novii System Interface Unit PART NUMBER 107-PT-001 SERIAL NUMBER TA1763 (TA1764, TA1762, TA1759, TA1752) HARDWARE VERSION Rev L SOFTWARE VERSION Rev 2.71 PSU VOLTAGE/FREQUENCY/CURRENT 100-240V / 50-60Hz / 2.5A HIGHEST INTERNALLY GENERATED / 26 MHz USED FREQUENCY FCC ID (if applicable) YOM-6961-MON INDUSTRY CANADA ID (if applicable) The Novii System Interface Unit is part of the Novii Wireless TECHNICAL DESCRIPTION Patch System: a Maternal/Fetal monitor that records Fetal (a brief description of the intended use and heart rate, Maternal Heart Rate and Uterine Contractions from operation) a pregnant subject. COUNTRY OF ORIGIN United Kingdom RF CHARACTERISTICS (if applicable) TRANSMITTER FREQUENCY 2402 to 2480 (Bluetooth) and 0.110 to 0.205 (Qi charger) OPERATING RANGE (MHz) RECEIVER FREQUENCY OPERATING 2402 to 2480 (Bluetooth) and 0.110 to 0.205 (Qi charger) RANGE (MHz) INTERMEDIATE FREQUENCIES 2440 MHz (Bluetooth) and 0.157 MHz (Qi charger) EMISSION DESIGNATOR(S): 1M00F1D (i.e. G1D, GXW) MODULATION TYPES: V2.1 + EDR (GFSK. Bluetooth) and frequency modulation (Qi (i.e. GMSK, QPSK) charger) OUTPUT POWER (W or dBm) 10 dBm (Bluetooth), 37dBm (Qi charger) SEPARATE BATTERY/POWER SUPPLY (if applicable) MANUFACTURING DESCRIPTION Novii Interface Unit Power Supply MANUFACTURER XP Power TYPE AC/DC power supply PART NUMBER ACM18US05 PSU VOLTAGE/FREQUENCY/CURRENT 100-240V / 50-60Hz / 2.5A COUNTRY OF ORIGIN China MODULES (if applicable) MANUFACTURING DESCRIPTION MANUFACTURER TYPE POWER FCC ID INDUSTRY CANADA ID EMISSION DESIGNATOR DHSS/FHSS/COMBINED OR OTHER COUNTRY OF ORIGIN ANCILLARIES (if applicable) MANUFACTURING DESCRIPTION Novii System Pod MANUFACTURER Monica Healthcare Ltd TYPE Novii Pod PART NUMBER 107-PT-003 SERIAL NUMBER AA5426, AA5431 COUNTRY OF ORIGIN United Kingdom COMMERCIAL-IN-CONFIDENCE Page 4 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE Novii System Pod MAIN EUT MANUFACTURING DESCRIPTION Novii System Pod for the Novii Wireless Patch System MANUFACTURER Monica Healthcare Ltd MODEL NAME/NUMBER Novii System Pod PART NUMBER 107-PT-003 SERIAL NUMBER AA5426, AA5431 (AA5425, AA5235, AA5266, AA5233) HARDWARE VERSION Rev H SOFTWARE VERSION Rev 2.54 PSU VOLTAGE/FREQUENCY/CURRENT Qi wireless charging (from Novii System Interface Unit) HIGHEST INTERNALLY GENERATED / 26MHz USED FREQUENCY FCC ID (if applicable) YOM-6960-MON INDUSTRY CANADA ID (if applicable) The Novii System Pod is part of the Novii Wireless Patch TECHNICAL DESCRIPTION System: a Maternal/Fetal monitor that records Fetal heart rate, (a brief description of the intended use and Maternal Heart Rate and Uterine Contractions from a pregnant operation) subject. COUNTRY OF ORIGIN United Kingdom RF CHARACTERISTICS (if applicable) TRANSMITTER FREQUENCY 2402 to 2480 (Bluetooth) and 0.110 to 0.205 (Qi charger) OPERATING RANGE (MHz) RECEIVER FREQUENCY OPERATING 2402 to 2480 (Bluetooth) and 0.110 to 0.205 (Qi charger) RANGE (MHz) INTERMEDIATE FREQUENCIES 2440 MHz (Bluetooth) and 0.157 MHz (Qi charger) EMISSION DESIGNATOR(S): 1M00F1D (i.e. G1D, GXW) MODULATION TYPES: V2.1 + EDR (GFSK. Bluetooth) and frequency modulation (Qi (i.e. GMSK, QPSK) charger) OUTPUT POWER (W or dBm) 10 dBm (Bluetooth) SEPARATE BATTERY/POWER SUPPLY (if applicable) MANUFACTURING DESCRIPTION Novii System Interface Unit MANUFACTURER Monica Healthcare Ltd TYPE Qi wireless charger PART NUMBER 107-PT-001 PSU VOLTAGE/FREQUENCY/CURRENT On receiver: 5V DC / 380mA COUNTRY OF ORIGIN United Kingdom MODULES (if applicable) MANUFACTURING DESCRIPTION MANUFACTURER TYPE POWER FCC ID INDUSTRY CANADA ID EMISSION DESIGNATOR DHSS/FHSS/COMBINED OR OTHER COUNTRY OF ORIGIN ANCILLARIES (if applicable) Novii System MANUFACTURING DESCRIPTION Novii System Patch Interface Unit Monica Healthcare Monica Healthcare MANUFACTURER Ltd Ltd TYPE Novii Interface Novii Patch PART NUMBER 107-PT-001 107-PT-004 TA1763 (TA1764, SERIAL NUMBER TA1762, TA1759, N/A (disposable) TA1752) COUNTRY OF ORIGIN United Kingdom USA COMMERCIAL-IN-CONFIDENCE Page 5 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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. 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: TA1772 0 As supplied by the customer Not Applicable Not Applicable Serial Number: AA5233 0 As supplied by the customer Not Applicable Not Applicable Table 3 COMMERCIAL-IN-CONFIDENCE Page 6 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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: Interface + Pod – Idle Radiated Emissions Paul Joynson and Graeme Lawler UKAS AC Power Line Conducted Emissions Paul Joynson and Graeme Lawler UKAS Table 4 Office Address: Octagon House Concorde Way Segensworth North Fareham Hampshire PO15 5RL United Kingdom COMMERCIAL-IN-CONFIDENCE Page 7 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 2 Test Details 2.1 Radiated Emissions 2.1.1 Specification Reference FCC 47 CFR Part 15B, Clause 15.109 2.1.2 Equipment Under Test and Modification State Interface, S/N: TA1772 - Modification State 0 Pod, S/N: AA5233- Modification State 0 2.1.3 Date of Test 04-December-2017 to 05-December-2017 2.1.4 Test Method The test was performed in accordance with ANSI C63.4, clause 8. 2.1.5 Environmental Conditions Ambient Temperature 18.1 °C Relative Humidity 37.0 % 2.1.6 Test Results Interface + Pod - Standby Highest frequency generated or used within the EUT: 2.5 GHz Upper frequency test limit: 13.5 GHz Frequency QP Level QP Limit QP Margin Angle(Deg) Height(m) Polarity (MHz) (dBuV/m) (dBuV/m) (dBuV/m) 83.835 19.3 39.1 -19.8 43 1.00 Vertical 84.761 24.2 39.1 -14.9 116 1.00 Vertical 85.628 17.8 39.1 -21.3 244 1.00 Vertical 493.318 34.1 46.4 -12.3 160 1.00 Vertical 618.755 29.6 46.4 -16.8 151 1.16 Vertical 690.703 38.7 46.4 -7.7 233 1.00 Horizontal 887.805 34.5 46.4 -11.9 129 1.00 Vertical Table 5 - 30 MHz to 1 GHz COMMERCIAL-IN-CONFIDENCE Page 8 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE Figure 1 - 30 MHz to 1 GHz - Horizontal and Vertical COMMERCIAL-IN-CONFIDENCE Page 9 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE Frequency Result (µV/m) Limit (µV/m) Margin (µV/m) Angle (°) Height Polarisation (GHz) (m) Peak Average Peak Average Peak Average 1.085332 45.16 41.61 69.54 49.54 24.45 7.93 173 350 Vertical 1.282613 44.49 39.22 69.54 49.54 25.5 10.32 165 302 Vertical Table 6 - 1 GHz to 13.5 GHz No other emissions were detected within 6 dB of the limit. * RBW 1 MHz Marker 1 [T1 ] * VBW50 kHz 41.74 dBµV/m Ref 80 dBµV/m * Att 0 dB SWT 160 ms 1.280448718 GHz 80 Offset -10 dB * FC15BA_P A 70 1 PK VIEW 60 LVL 2 PK MAXH TDS FC15BA_A 50 1 PA PS 40 30 6DB 20 AC 10 0 -10 -20 Start 1 GHz 700 MHz/ Stop 8 GHz Date: 4.DEC.2017 20:37:08 Figure 2 - 1 GHz to 8 GHz - Horizontal and Vertical COMMERCIAL-IN-CONFIDENCE Page 10 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE * RBW 1 MHz Marker 1 [T1 ] * VBW50 kHz 35.55 dBµV/m Ref 80 dBµV/m * Att 0 dB SWT 125 ms 12.971153846 GHz 80 Offset -10 dB * FC15BA_P A 70 1 PK VIEW 60 LVL 2 PK MAXH TDS FC15BA_A 50 PS 40 1 30 6DB 20 AC 10 0 -10 -20 Start 8 GHz 550 MHz/ Stop 13.5 GHz Date: 4.DEC.2017 22:00:33 Figure 3 - 8 GHz to 13.5 GHz - Horizontal and Vertical FCC 47 CFR Part 15, Limit Clause 15.109 Frequency of Emission (MHz) Field Strength (µV/m) 30 to 88 90.0 88 to 216 150.0 216 to 960 210.0 Above 960 300.0 2.1.7 COMMERCIAL-IN-CONFIDENCE Page 11 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 2.1.8 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) Antenna (Bilog) Schaffner CBL6143 287 24 18-Apr-2018 Pre-Amplifier Phase One PS04-0086 1533 12 31-Jul-2018 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 NPS-2302-8000- Cable (N-N, 8m) Rhophase 3248 12 02-May-2018 NPS EMI Test Receiver Rohde & Schwarz ESU40 3506 12 22-Nov-2018 Tilt Antenna Mast maturo Gmbh TAM 4.0-P 3916 - TU Mast Controller maturo Gmbh NCD 3917 - TU KPS-1501-2000- Cable (Rx, Km-Km 2m) Scott Cables 4526 6 22-May-2018 KPS Cable (Rx, SMAm-SMAm SLSLL18-SMSM- Scott Cables 4528 6 03-Feb-2017 0.5m) 00.50M Double Ridged ETS-Lindgren 3117 4722 12 17-Feb-2018 Waveguide Horn Antenna Double Ridge Broadband Schwarzbeck BBHA 9120 B 4848 12 17-Feb-2018 Horn Antenna Table 7 TU - Traceability Unscheduled COMMERCIAL-IN-CONFIDENCE Page 12 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 2.2 AC Power Line Conducted Emissions 2.2.1 Specification Reference FCC 47 CFR Part 15B, Clause 15.107 2.2.2 Equipment Under Test and Modification State Interface, S/N: TA1772 - Modification State 0 2.2.3 Date of Test 03-December-2017 to 05-December-2017 2.2.4 Test Method The test was performed in accordance with ANSI C63.4, clause 7. 2.2.5 Environmental Conditions Ambient Temperature 18.1 °C Relative Humidity 37.0 % 2.2.6 Test Results Interface + Pod - Standby 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) 0.152 48.0 79.0 -31.0 35.9 66.0 -30.1 0.288 45.6 79.0 -33.4 44.9 66.0 -21.1 0.504 43.2 73.0 -29.8 42.9 60.0 -17.1 0.790 42.8 73.0 -30.2 42.2 60.0 -17.8 0.863 43.6 73.0 -29.4 42.8 60.0 -17.2 1.152 43.5 73.0 -29.5 42.4 60.0 -17.6 Table 8 - Live Line Emissions Results COMMERCIAL-IN-CONFIDENCE Page 13 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE Figure 4 - Live Line - 150 kHz to 30 MHz COMMERCIAL-IN-CONFIDENCE Page 14 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE Frequency QP Level QP Limit QP Margin AV Level AV Limit AV Margin (MHz) (dBuV) (dBuV) (dBuV) (dBuV) (dBuV) (dBuV) 0.152 47.8 79.0 -31.2 36.7 66.0 -29.3 0.288 45.5 79.0 -33.5 44.8 66.0 -21.2 0.503 43.3 73.0 -29.7 42.9 60.0 -17.1 0.791 43.4 73.0 -29.6 42.7 60.0 -17.3 0.864 43.6 73.0 -29.4 42.9 60.0 -17.1 1.151 43.8 73.0 -29.2 42.7 60.0 -17.3 Table 9 - Neutral Line Emissions Results Figure 5 - Neutral Line - 150 kHz to 30 MHz FCC 47 CFR Part 15, Limit Clause 15.107 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 Table 10 *Decreases with the logarithm of the frequency. COMMERCIAL-IN-CONFIDENCE Page 15 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 2.2.7 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 COMMERCIAL-IN-CONFIDENCE Page 16 of 17

Document Number: 75941097-01 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 3 Measurement Uncertainty For a 95% confidence level, the measurement uncertainties for defined systems are: Test Name Measurement Uncertainty Radiated Emissions 30 MHz to 1 GHz: ±5.2 dB 1 GHz to 40 GHz: ±6.3 dB AC Power Line Conducted Emissions 150 kHz to 30 MHz, LISN, ±3.7 dB Table 12 COMMERCIAL-IN-CONFIDENCE Page 17 of 17


Document Created: 2017-12-13 12:06:56
Document Modified: 2017-12-13 12:06:56
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