Test report 75941097-03 Issue 1

FCC ID: YOM-6961-MON

Test Report

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FCCID_3677629

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

Document Number: 75941097-03 | 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 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 COMMERCIAL-IN-CONFIDENCE Page 1 of 17

Document Number: 75941097-03 | 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) 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) COMMERCIAL-IN-CONFIDENCE Page 2 of 17

Document Number: 75941097-03 | 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 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 COMMERCIAL-IN-CONFIDENCE Page 3 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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 COMMERCIAL-IN-CONFIDENCE Page 4 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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 COMMERCIAL-IN-CONFIDENCE Page 5 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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 COMMERCIAL-IN-CONFIDENCE Page 6 of 17

Document Number: 75941097-03 | 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. 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 COMMERCIAL-IN-CONFIDENCE Page 7 of 17

Document Number: 75941097-03 | 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: 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 COMMERCIAL-IN-CONFIDENCE Page 8 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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) COMMERCIAL-IN-CONFIDENCE Page 9 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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 COMMERCIAL-IN-CONFIDENCE Page 10 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE * 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 COMMERCIAL-IN-CONFIDENCE Page 11 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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 COMMERCIAL-IN-CONFIDENCE Page 12 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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 COMMERCIAL-IN-CONFIDENCE Page 13 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE Figure 5 - Live Line - 150 kHz to 30 MHz COMMERCIAL-IN-CONFIDENCE Page 14 of 17

Document Number: 75941097-03 | 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) 0.150 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 COMMERCIAL-IN-CONFIDENCE Page 15 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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 COMMERCIAL-IN-CONFIDENCE Page 16 of 17

Document Number: 75941097-03 | Issue: 01 COMMERCIAL-IN-CONFIDENCE 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 COMMERCIAL-IN-CONFIDENCE Page 17 of 17


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