WWO-CTCBLEBody-worn physiological monitor

Indication for use: The DuoFertility-2 should be used by women who are interested in measuring physiological information that is likely to correspond to their time of ovulation. This will indicate the best time for them to try for a baby. Contraindications for use: The DuoFertility-2 device must not be used as a contraceptive; unintended pregnancy may occur as a result. It should not be used as a medical thermometer to detect fever; as this could result in a delay in detecting serious illness. It is not suitable if you have reached menopause. This device is for home use: During normal operation of the DuoFertility-2 Sensor, the temperature should be between +5C and +40C, the atmospheric pressure range should be between 700hPa to 1060hPa and the relative humidity range should be between 15% and 93%, Non-condensing. Transportation and storage conditions should not exceed an atmospheric pressure of 1060hPa, 70C (and not below -25C) and up to 93% humidity Non-condensing. Keep out of reach of children and pets Not made with natural rubber latex ° ° °° Fertility monitoring system The box contains one DuoFertility-2 sensor. DuoFertility-2 Assisted Natural Conception 1.Regulatory Information: 1.1.FCC This device has FCC ID: WWO-CTCBLE-This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: Ÿthis device may not cause harmful interference, and Ÿthis device must accept any interference received, including interference that may cause undesired operation. FCC - This device complies with the FCC safety requirements for RF exposure in accordance with FCC rule part §2.1093 and KDB447498 D01. for portable use conditions. No changes shall be made to the equipment without the manufacturer’s permission as this may void the user’s authority to operate the equipment. app and onto our servers as long as you have the DuoFertility-2 app running on your device, your Bluetooth is active and you have not disabled the auto-sync for your sensor. I have a missing temperature point, what do I do? There are several possible reasons for this. If you have been wearing the sensor every night and enabled the device to synchronise automatically, then we would recommend that you synchronise your data with our fertility centre manually and contact the customer care line who will be able to help. How do I get in touch with a fertility expert and how can I contact DuoFertility-2? The best way to get in touch with a fertility expert is to send an email with your question ([email protected]), and your fertility expert will get in touch with you. If it is urgent, you may also call and be directed to the first fertility expert available. (Careline +44 (0)1223 967703) Will sleeping with a hot water bottle affect my temperature measurements? This should not affect your temperature measurements unless the hot water bottle is very close to where you are wearing the sensor. Can I use DuoFertility-2 in the shower? Is it safe? Yes, the sensor can be worn in the shower. 1.2.Industry Canada IC This device has Industry Canada ID IC: 10842A- CTCBLE-This Class B digital apparatus complies with Canadian ICES-003. Operation is subject to the following two conditions: Ÿthis device may not cause interference, and Ÿthis device must accept any interference, including interference that may cause undesired operation of the device. IC - This device complies with the safety requirements for RF exposure in accordance with RSS-102 Issue 5 for portable use conditions. 5.3.3 Frequently asked questions about DuoFertility-2 When should I start using DuoFertility-2? We suggest that you start using DuoFertility-2 as soon as you receive it, rather than waiting until the beginning of your next cycle. This will allow the sensor to collect as much valuable temperature data as possible which will help to ensure the accuracy of all the fertility predictions that you are given. However, don’t forget to activate the sensor before you start wearing it, by using the DuoFertility-2 app on a phone/tablet or the Sensor Sync Tool on a computer. Do I have to use all the information tabs on the app? For most people, the correct measurement of BBT is enough to reliably identify the fertile window. Nevertheless, recording additional information will increase the accuracy of detection of your fertile window, especially if your cycles are very irregular. Does DuoFertility-2 keep my private data secure? We ensure that all data is kept secure and completely confidential. All data that you upload to our servers is encrypted. How do I transfer my data to the DuoFertility-2 centre? Data is downloaded automatically from your sensor to your 2. Indications for use The DuoFertility-2 Monitor is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception). 3. Contraindications for use: THIS PRODUCT IS NOT FOR CONRACEPTIVE USE; Unintended pregnancy may occur as a result. It must NOT be used as a medical thermometer to detect fever as this could result in a delay in detecting serious illness. It is not suitable if you have reached menopause. The temperature measurement is accurate to 0.05°C 4. Warnings and Precautions If you have been actively using DuoFertility-2 and having regular intercourse during your predicted fertile days for six months without managing to conceive, please contact your doctor for further advice if you have not previously done so. DuoFertility-2 is suitable for women with a wide range of conditions, such as hormonal disorders (including polycystic ovarian syndrome) and irregular menstrual cycles. The use of DuoFertility-2 may cause irritation to the skin from wearing the adhesive. If irritation persists, please discontinue use and contact your doctor. Also, please report 5.3 Further Information: 5.3.1 Contents of the DuoFertility-2 box The Duofertility-2 box should contain: ŸThe Duofertility-2 sensor ŸThe instructions …

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Cambridge Temperature Concepts Ltd. 23 Cambridge Science Park Milton Road Cambridge CB4 0EY Tel: 01223 967707 Fax: 01223 437 008 www.temperatureconcepts.com www.duofertility.com P a g e | 1 Cambridge Temperature Concepts Limited is a UK registered company (number 5943341), with registered offices at Downing Enterprise, Downing College, University of Cambridge, Regent Street, Cambridge CB2 1DQ, United Kingdom. VAT registration number 922 0511 71. July 21, 2015 Telecommunication Certification Body UL VS Ltd Offices 18-26 Grove House Lutyens Close Chineham Court Basingstoke Hampshire RG24 8AG United Kingdom Subject: Agency Letter To whom it may concern This is to certify that Cambridge Temperature Concepts Limited hereby authorises UL VS Ltd. to act as the TCB for the application of the DuoFertility sensor, FCC ID: WWO-CTCBLE to the FCC. We certify that we are not subject to a denial of Federal benefits, that include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. § 862 because of a conviction for possession or distribution of a controlled substance. See 47 CFR 1.2002(b) for the definition of a "party" for these purposes. Yours faithfully Dr. Shamus Husheer

Cambridge Temperature Concepts Ltd. 23 Cambridge Science Park Milton Road Cambridge CB4 0EY Tel: 01223 967707 Fax: 01223 437 008 www.temperatureconcepts.com www.duofertility.com P a g e | 1 Cambridge Temperature Concepts Limited is a UK registered company (number 5943341), with registered offices at Downing Enterprise, Downing College, University of Cambridge, Regent Street, Cambridge CB2 1DQ, United Kingdom. VAT registration number 922 0511 71. July 21, 2015 Telecommunication Certification Body UL VS Ltd Offices 18-26 Grove House Lutyens Close Chineham Court Basingstoke Hampshire RG24 8AG United Kingdom Subject: Permanent Confidentiality Request Certification Application FCC ID: WWO-CTCBLE To whom it may concern Pursuant to Sections 0.457 and 0.459 of CFR 47 , Cambridge Temperature Concepts Limited request that the following information, provided to support the FCC application for the DuoFertility sensor, FCC ID: WWO-CTCBLE be held permanently confidential: Schematics Block Diagrams Operational Description The above material contains trade secrets not customarily released to public that are judged to have the potential to cause detriment to the applicant and provide unjustified benefits to its competitors. This information should not be available for public disclosure for an indefinite period of time. Yours faithfully Dr. Shamus Husheer

Cambridge Temperature Concepts Ltd. 23 Cambridge Science Park Milton Road Cambridge CB4 0EY Tel: 01223 967707 Fax: 01223 437 008 www.temperatureconcepts.com www.duofertility.com P a g e | 1 Cambridge Temperature Concepts Limited is a UK registered company (number 5943341), with registered offices at Downing Enterprise, Downing College, University of Cambridge, Regent Street, Cambridge CB2 1DQ, United Kingdom. VAT registration number 922 0511 71. July 21, 2015 Telecommunication Certification Body UL VS Ltd Offices 18-26 Grove House Lutyens Close Chineham Court Basingstoke Hampshire RG24 8AG United Kingdom Subject: Short Term Confidentiality Request Certification Application FCC ID: WWO-CTCBLE To whom it may concern Pursuant to Sections 0.457 and 0.459 of CFR 47 , Cambridge Temperature Concepts Limited requests the short term confidentiality of the items listed below until 1 October 2015 for our device, FCC ID: WWO-CTCBLE: • Internal Photos • Test Set Up Photos • User Guide These items contain proprietary information related to the design of the product which has not yet been released to the market. The public disclosure of this information prior to public launch may be harmful to Cambridge Temperature Concepts Limited and provide unjust benefits to its competitors. A period up to 1 October 2015 is requested to protect this information before formal market launch. If the launch date is re-scheduled to be earlier than 1 October 2015, Cambridge Temperature Concepts Limited will inform again to cancel this restriction. Please contact the undersigned if there are any further questions or additional information needed in this matter. Yours faithfully Dr. Shamus Husheer

WWO-CTCBLE External Photographs (2x Actual Size) Polymer Encapsulated, Top View Polymer Encapsulated, Bottom View

Cambridge Temperature Concepts Ltd. 23 Cambridge Science Park Milton Road Cambridge CB4 0EY Tel: 01223 967707 Fax: 01223 437 008 www.temperatureconcepts.com www.duofertility.com P a g e | 1 Cambridge Temperature Concepts Limited is a UK registered company (number 5943341), with registered offices at Downing Enterprise, Downing College, University of Cambridge, Regent Street, Cambridge CB2 1DQ, United Kingdom. VAT registration number 922 0511 71. July 21, 2015 Telecommunication Certification Body UL VS Ltd Offices 18-26 Grove House Lutyens Close Chineham Court Basingstoke Hampshire RG24 8AG United Kingdom Subject: Labelling for Certification Application FCC ID: WWO-CTCBLE To whom it may concern FCC ID: WWO-CTCBLE is new version of our previous product with FCC-ID: WWO-CTCDFR, an FDA cleared fertility monitoring device. The WWO-CTCDFR product consists of a small bodyworn electronic sensor, which communicates wirelessly (via RFID) to a handheld reader. The sensor is designed to be worn, using a replaceable adhesive, for many months (6 months being common). The FCCID is printed on the handheld reader, with no markings on the sensor. The next generation of the product, WWO-CTCBLE, is a similar sensor that communicates directly to the user's smartphone via Bluetooth Low Energy. This means there is no handheld reader device to print the FCCID on. The sensor is rather small (a disc about 28mm diameter by 9mm thick), and entirely coated in a skin-safe elastic polymer. This polymer is very difficult to print on, though in theory we could emboss/deboss the FCCID into the polymer. However, this would result in a buildup of dead skin and other dross over the use period of ~6 months, which could lead to skin irritation or infection, and potentially the embossing itself could be irritating to the skin if embossed to any great degree. We therefore propose to include the FCCID and labelling requirements in the manual for the sensor, rather than the sensor itself. I understand that this is possible provided that approval is given to do so, according to section 2.2 of: https://apps.fcc.gov/kdb/GetAttachment.html?id=gSc9BH6v7Z%2FdopMkplqCZQ%3D%3D Yours faithfully Dr. Shamus Husheer

WWO-CTCBLE Internal Photographs (2x Actual Size) Pre-Encapsulation, Top View Pre-Encapsulation, Bottom View Pre-Encapsulation, Exploded View

Cambridge Temperature Concepts Ltd. 23 Cambridge Science Park Milton Road Cambridge CB4 0EY Tel: 01223 967707 Fax: 01223 437 008 www.temperatureconcepts.com www.duofertility.com P a g e | 1 Cambridge Temperature Concepts Limited is a UK registered company (number 5943341), with registered offices at Downing Enterprise, Downing College, University of Cambridge, Regent Street, Cambridge CB2 1DQ, United Kingdom. VAT registration number 922 0511 71. July 21, 2015 Telecommunication Certification Body UL VS Ltd Offices 18-26 Grove House Lutyens Close Chineham Court Basingstoke Hampshire RG24 8AG United Kingdom Subject: Tune Up Information for Certification Application FCC ID: WWO-CTCBLE To whom it may concern The WWO-CTCBLE radio consists of a Nordic Semiconductor nRF8001 Bluetooth Low Energy IC. The Bluetooth radio with balun and matching used, and therefore the WWO-CTCBLE as a whole, has a maximum conducted output power of 0dBm (including tolerance) at 2402-2480MHz, with 2MHz channel spacing. Yours faithfully Dr. Shamus Husheer

Cambridge Temperature Concepts Ltd. 23 Cambridge Science Park Milton Road Cambridge CB4 0EY Tel: 01223 967707 Fax: 01223 437 008 www.temperatureconcepts.com www.duofertility.com P a g e | 1 Cambridge Temperature Concepts Limited is a UK registered company (number 5943341), with registered offices at Downing Enterprise, Downing College, University of Cambridge, Regent Street, Cambridge CB2 1DQ, United Kingdom. VAT registration number 922 0511 71. July 21, 2015 Telecommunication Certification Body UL VS Ltd Offices 18-26 Grove House Lutyens Close Chineham Court Basingstoke Hampshire RG24 8AG United Kingdom Subject: SAR calculation for Certification Application FCC ID: WWO-CTCBLE To whom it may concern The Bluetooth radio with blaun and matching used has a maximum radio output of 0dBm (=1mW), including tolerance, at 2402 to 2480MHz. According to FCC KDB 447498 D01 General RF Exposure Guidance v05r02, section 4.3.1, the following calculation is used to establish SAR exemption: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] • [ √f (GHz) ] This must be below 3.0. For separations of less than 5mm, a figure of 5mm is used. At 1mW maximum power, 5mm separation distance, and 2.45GHz frequency, the result of the calculation is 0.313, well below the limit of 3.0. Therefore this product is exempt from routine evaluation. Yours faithfully Dr. Shamus Husheer

UL VS LTD Pavilion A, Ashwood Park, Ashwood Way, Basingstoke, Hampshire, RG23 8BG, UK Telephone: +44 (0)1256 312000 Facsimile: +44 (0)1256 312001 TEST REPORT Test Report No. : UL-RPT-RP10299547JD05A V2.0 Manufacturer : Cambridge Temperature Concepts Model No. : WWO-CTCBLE FCC ID : WWO-CTCBLE Technology : Bluetooth – Low Energy Test Standard(s) : FCC Parts 15.207, 15.209(a) & 15.247 1. This test report shall not be reproduced in full or partial, without the written approval of UL VS LTD. 2. The results in this report apply only to the sample(s) tested. 3. The sample tested is in compliance with the above standard(s). 4. The test results in this report are traceable to the national or international standards. 5. Version 2.0 supersedes all previous versions. Date of Issue: 14 July 2015 Checked by: Sarah Williams Engineer, Radio Laboratory Issued by : pp John Newell Quality Manager, UL VS LTD This laboratory is accredited by UKAS. The tests reported herein have been performed in accordance with its’ terms of accreditation. The Bluetooth ® word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by UL VS LTD is under licence. Other trademarks and trade names are those of their respective owners. TEST REPORT SERIAL NO: UL-RPT-RP10299547JD05A VERSION 2.0 ISSUE DATE: 14 JULY 2015 Page 2 of 28 UL VS LTD This page has been left intentionally blank. TEST REPORT SERIAL NO: UL-RPT-RP10299547JD05A VERSION 2.0 ISSUE DATE: 14 JULY 2015 UL VS LTD Page 3 of 28 Table of Contents 1. Customer Information ................................................................................................................ 4 2. Summary of Testing ................................................................................................................... 5 2.1. General Information 5 2.2. Summary of Test Results 5 2.3. Methods and Procedures 6 2.4. Deviations from the Test Specification 6 3. Equipment Under Test (EUT) .................................................................................................... 7 3.1. Identification of Equipment Under Test (EUT) 7 3.2. Description of EUT 7 3.3. Modifications Incorporated in the EUT 7 3.4. Additional Information Related to Testing 8 3.5. Support Equipment 8 4. Operation and Monitoring of the EUT during Testing ............................................................. 9 4.1. Operating Modes 9 4.2. Configuration and Peripherals 9 5. Measurements, Examinations and Derived Results ...............................................................10 5.1. General Comments 10 5.2. Test Results 11 5.2.1. Receiver/Idle Mode Radiated Spurious Emissions 11 5.2.2. Transmitter Minimum 6 dB Bandwidth 15 5.2.3. Transmitter Maximum Peak Output Power 17 5.2.4. Transmitter Radiated Emissions 19 5.2.5. Transmitter Band Edge Radiated Emissions 25 6. Measurement Uncertainty ........................................................................................................27 7. Report Revision History ...........................................................................................................28 TEST REPORT SERIAL NO: UL-RPT-RP10299547JD05A VERSION 2.0 ISSUE DATE: 14 JULY 2015 Page 4 of 28 UL VS LTD 1. Customer Information Company Name: Cambridge Temperature Concepts Address: 23 Science Park Cambridge Cambridgeshire CB4 0EY United Kingdom TEST REPORT SERIAL NO: UL-RPT-RP10299547JD05A VERSION 2.0 ISSUE DATE: 14 JULY 2015 UL VS LTD Page 5 of 28 2. Summary of Testing 2.1. General Information Specification Reference: 47CFR15.247 Specification Title: Code of Federal Regulations Volume 47 (Telecommunications): Part 15 Subpart C (Intentional Radiators) - Section 15.247 47CFR15.109 Specification Title: Code of Federal Regulations Volume 47 (Telecommunications): Part 15 Subpart B (Unintentional Radiators) - Section 15.109 Specification Reference: 47CFR15.209 Specification Title: Code of Federal Regulations Volume 47 (Telecommunications): Part 15 Subpart C (Intentional Radiators) - Section 15.209 Site Registration: 209735 Location of Testing: UL VS LTD, Unit 3 Horizon, Wade Road, Kingsland Business Park, Basingstoke, Hampshire, RG24 8AH, United Kingdom Test Dates: 29 April 2014 to 10 July 2015 2.2. Summary of Test Results FCC Reference (47CFR) Measurement Result Part 15.109 Receiver/Idle Mode Radiated Emissions Part 15.247(a)(2) Transmitter Minimum 6 dB Bandwidth Part 15.247(e) Transmitter Power Spectral Density Note 1 Part 15.247(b)(3) Transmitter Maximum Peak Output Power Part 15.247(d)/15.209(a) Transmitter Radiated Emissions Part 15.247(d)/15.209(a) Transmitter Band Edge Radiated Emissions Key to Results = Complied = Did not comply Note(s): 1. In accordance with FCC KDB 558074 Section 10.1, PSD is not required if the maximum conducted output power is less than the PSD limit of 8 dBm / 3 kHz. The PSD level is therefore deemed to be equal to the measured total output power. TEST REPORT SERIAL NO: UL-RPT-RP10299547JD05A VERSION 2.0 ISSUE DATE: 14 JULY 2015 Page 6 of 28 UL VS LTD 2.3. Methods and Procedures Reference: ANSI C63.4 (2009) Title: American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz Reference: ANSI C63.10 (2009) Title: American National Standard for Testing Unlicensed Wireless Devices Reference: KDB 558074 D01 v03r03 June 9, 2015 Title: Guidance for Performing Compliance Measurements on Digital Transmission Systems (DTS) Operating Under §15.247 2.4. Deviations from the Test Specification For the measurements contained within this test report, there were no deviations from, additions to, or exclusions from the test specification identified above. TEST REPORT SERIAL NO: UL-RPT-RP10299547JD05A VERSION 2.0 ISSUE DATE: 14 JULY 2015 UL VS LTD Page 7 of 28 3. Equipment Under Test (EUT) 3.1. Identification of Equipment Under Test (EUT) Brand Name: DuoFertility Model Name or Number: WWO-CTCBLE Test Sample Serial Number: 13B136E44D…

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FCC ID: WWO-CTCBLE IC: 12167A-CTCBLE Test Set Up Photos for the Cambridge Temperature Concepts DuoFertility Device FCC ID: WWO-CTCBLE IC: 12167A-CTCBLE