FCC ID: 2AE3ZPT-DS-5000 TempuRing

TempuRing Personal Fertility Sensor User Manual Prima-Temp, Inc Version: 1 Protocol No: PT-001 TempuRing User Manual TEMPURING User Manual Thank you for choosing TEMPURING. TEMPURING personal fertility sensor automatically, continuously and effortlessly measures your core body temperature via a temperature sensor. The sensor transmits temperature data wirelessly to the TEMPURING App on your smart phone or iPod. We wish you the best in your personal fertility path forward. Your friends at Prima-Temp, Inc www.prima-temp.com This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 2.925(a)(1) FCC ID: 2AE3ZPT-DS-5000 FCC Information on software application can be found be opening Priya app, clicking on menu in upper left corner, and clicking on About. Caution: changes or modifications not expressly approved by Prima-Temp, Inc could void the user's authority to operate the equipment. Version: 06/10/2015 Page 2 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 CONTENTS 1 TEMPURING DESCRIPTION .................................................................................. 6 Components of TEMPURING .............................................................................. 6 Indication for Use ................................................................................................. 6 2 INSTRUCTIONS FOR MEASURING AND RECORDING ORAL TEMPERATURE, FACTORS THAT MAY AFFECT TEMPERATURE, AND URINARY LH ........................................................................................................... 7 The TEMPURING Apps My Diary Entry ............................................................ 7 About You Screen ....................................................................................... 7 To Add New Cycle ...................................................................................... 8 Add Period End Date ................................................................................. 9 Main Menu ................................................................................................ 10 My Diary Screen ........................................................................................ 12 ORAL TEMPERATURE MEASUREMENT AND RECORDING INSTRUCTIONS ................................................................................................ 13 Recording Your Oral Temperature and the Time You Took Your Temperature ...................................................................................................... 14 FACTOR INSTRUCTIONS ............................................................................... 15 URINARY LUTEINIZING HORMONE (LH) MEASUREMENTS AND RECORDING INSTRUCTIONS ......................................................................... 18 Record Your LH Result ............................................................................. 18 3 Instructions for TEMPURING Use ...................................................................... 19 Turn on Bluetooth on your iPhone/iPod ............................................................. 20 TEMPURING Pairing with iPhone/iPod ............................................................. 21 TEMPURING Activation .................................................................................... 23 Inserting TEMPURING ...................................................................................... 25 Step 1. Choose a position for insertion of TEMPURING ........................... 25 Step 2. Prepare TEMPURING for insertion ............................................... 26 Step 3. Insert TEMPURING into your vagina ............................................ 26 Step 4. Removing TEMPURING ............................................................... 27 Step 5. Used TEMPURING ....................................................................... 28 4 Temperature Data Transfer ................................................................................. 28 5 Temperature Data Sent to your iPod/iPhone ..................................................... 29 Version: 06/10/2015 Page 3 of 42 Protocol No: PT-001 TempuRing User Manual 6 REPORTS TO SPONSOR ..................................................................................... 29 Prima-Temp, Inc Version: 1 You will be asked to export / email three (3) sets of data from your app to the Study Sponsor on a weekly basis: the My Diary report, the TEMPURING temperature data report, and the TEMPURING Logs. ............. 29 My Diary Data Reports (1) ............................................................................... 29 TempuRing Temperature Data Reports (2) ....................................................... 31 TempuRing App Logs Reports (3) ..................................................................... 33 Multiple Devices ................................................................................................ 35 Notifications ....................................................................................................... 37 7 FAQs: .................................................................................................................... 38 How should I Use TEMPURING? ...................................................................... 38 How do I wear TEMPURING? ........................................................................... 38 What if I dont use TEMPURING for the whole time period? ............................. 38 How long should I wear TEMPURING? ............................................................. 38 How Should I clean TEMPURING ..................................................................... 39 Can I sterilize TEMPURING using sterilizing solutions? ................................... 39 What are the restrictions on using birth control, yeast infection treatments, and tampons while using TEMPURING? .......................................................... 39 What are the possible side effects of TEMPURING? ........................................ 40 How should I store TEMPURING? .................................................................... 41 How is TEMPURING Supplied? ........................................................................ 42 What if I miss my regularly scheduled period when using TEMPURING? ........ 42 Can I have sexual intercourse while wearing TEMPURING? ............................ 42 Can I started using TEMPURING later and not on the first day after my period stopped? ................................................................................................. 42 What should I do if TEMPURING is damaged or lost? ...................................... 42 Can I give TEMPURING to a friend? ................................................................. 42 Version: 06/10/2015 Page 4 of 42 Prima-Temp, Inc Version: 1 Protocol No: PT-001 TempuRing User Manual Manufacturer Prima-Temp, Inc. 2820 Wilderness Place, Suite C Boulder, Colorado 80301 United States 1-866-398-1032 www.Prima-Temp.com Version: 06/10/2015 Page 5 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 1 TEMPURING DESCRIPTION TEMPURING personal fertility sensor consists of a flexible vaginal ring that is self-

inserted at home. TEMPURING automatically and continuously measures your core body temperature via a temperature sensor inside of the ring. The sensor transmits temperature data wirelessly to the TEMPURING App (called Priya) on your smart phone or iPod, where the temperature data are collected. The TEMPURING App (Priya) can be used with an iPhone (4s and higher, with iOS 7 and higher) and iPod Touch (3rd generation or higher). Components of TEMPURING The TEMPURING system has two parts the TEMPURING vaginal ring sensor, and the TEMPURING mobile App (Priya). Sensor App The TEMPURING vaginal ring sensor is made of medical-grade silicone. It is for vaginal use only. When you first unpack TEMPURING, it must be activated and paired with your iPhone/iPod (see TEMPURING Activation and Pairing with iPhone/iPod below). It is best to keep your iPhone/iPod with you at all times to ensure the most accurate communication and data transfer from TEMPURING. Indication for Use TEMPURING is intended for continuously measuring and recording core body temperature as an aid in ovulation prediction to aid in conception. THIS PRODUCT IS NOT TO BE USED FOR CONTRACEPTION Version: 06/10/2015 Page 6 of 42 Protocol No: PT-001 TempuRing User Manual 2 Prima-Temp, Inc Version: 1 INSTRUCTIONS FOR MEASURING AND RECORDING ORAL TEMPERATURE, FACTORS THAT MAY AFFECT TEMPERATURE, AND URINARY LH The TEMPURING Apps My Diary Entry You must start using your TEMPURING App (Priya) on the first day of your menstrual cycle / your period (the first day of bleeding or spotting is the first day of your cycle -

Cycle Day 1). The TEMPURING App will store all of your cycle information, your oral Temperature data, your Factors (that may affect your core body temperature), Luteinizing Hormone

(LH) data, and TempuRing Temperature. Please bring your provided iPod/iPhone to every study visit. The study coordinator or study nurse will review all the data stored in the TEMPURING App (Priya) and will export and email all your collected data to the study sponsor. You will also be emailing your data to the study sponsor please refer to Reports to Sponsor section below. To begin using your TEMPURING App (Priya), please go to TEMPURING App (Priya) on provided iPod/iPhone. About You Screen In the About You screen. Enter your name, email, and date of birth. The study coordinator or nurse will enter your study ID. DO NOT CHANGE YOUR STUDY ID. After filling in your name, email and date of birth, tap Save. Version: 06/10/2015 Page 7 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 It will ask you to confirm your entry. Please confirm by clicking sure. Enter Name Enter Email address Study Coordinator enters subject ID Enter Date of Birth Tap on Save Click on Sure to Confirm To Add New Cycle Tap on Add a Cycle Select Start Date, which is the first day of your cycle (the first day of bleeding or spotting is the first day of your cycle - Cycle Day 1). Tap on Save. Version: 06/10/2015 Page 8 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tap on add a Cycle Select a Start Date of your cycle and Tap Save Add Period End Date This is the last day of your period, or the last day of bleeding or spotting. Once your period ends, next to Period Ended, Tap on Add Date. Select the date when you period ended. Version: 06/10/2015 Page 9 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 On the day your period ends, next to Period Ended, Tap on Add Date to enter the day. Select a date and Tap on Save Main Menu Tap on Main Menu the 3 small lines in the upper left of the app screen. Click on Cycles to monitor your current and previous cycles. Version: 06/10/2015 Page 10 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tap on Main Menu Tap on Cycles to go to Cycles Screen Tap on Devices to go to Device Screen Version: 06/10/2015 Page 11 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Cycles Screen Device Screen My Diary Screen Tap on Current Cycle. Program will take you to My Diary screen. To navigate from day to day, Tap on the date bar under My Diary. Version: 06/10/2015 Page 12 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tap on Current Cycle to see the My Diary screen. My Diary Screen Tap on Date to navigate from day to day. ORAL TEMPERATURE MEASUREMENT AND RECORDING INSTRUCTIONS Some important guidelines to follow:

Start measuring your oral temperature on day one of your period (the first day of bleeding or spotting is the first day of your cycle (Cycle Day 1)) and stop the first day of your next period. This is the length of your cycle. Place the thermometer and iPod/iPhone with TEMPURING App next to your bedside before you go to sleep. Version: 06/10/2015 Page 13 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Set an alarm to wake you at the same time every morning. The time you took your temperature is important for the analysis be sure to record this in the App

(under My Diary).

*It is important to take your temperature every morning at the same time.*

Record your temperature as soon as you take it. Take your temperature as soon as you wake up, before doing anything: DO NOT stand up, walk around or go to the bathroom, eat anything, drink anything, or engage in any kind of activity until after you have taken your oral temperature. Use the oral digital thermometer provided for this study. If it stops working, or you lose it, or you use a new one, make a note of it in the Factors section in your APP. Recording Your Oral Temperature and the Time You Took Your Temperature Tap on Current Cycle. Program will take you to My Diary screen. Tap on Fahrenheit Next to Temperature and record the oral temperature. Record the temperature to the tenths decimal place (record 97.0 rather than 97). Tap next to Time Taken and select the time you took your temperature; e.g. if you take your temperature at 6:30 am, select 6:30 am. You will also record Factors that may influence your core body temperature for that day see next section below. Tap on Temperature to record the oral temperature. Tap on Time Taken to select the time you took your oral temperature. Version: 06/10/2015 Page 14 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Select the time you took your oral temperature. Select AM. Tap on Time Taken again. Tap on Save FACTOR INSTRUCTIONS There are certain factors that can influence your temperature. These Factors should be noted in the App. Tap on Current Cycle. Program will take you to My Diary screen:

If you were exposed to any factors during the day and/or night of your oral temperature recording, tap on Factors to select a factor that you were exposed to. If you were exposed to more than one factor, Tap on the + to add additional factors that you were exposed. Factor Table Number Factors May Influence Your Oral Temperature 1 2 3 4 5 6 7 8 9 Fever Illness and infections (even those that do not produce a fever) Cold, sore throat Drugs and medications Alcohol (especially in large quantities, though all alcohol consumption should be recorded) Smoking Emotional stress Physical stress Excitement Version: 06/10/2015 Page 15 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Factor Table Number Factors May Influence Your Oral Temperature 10 11 12 13 14 15 16 17 18 19 20 21 22 Change in waking time Jet lag Travel Change time zone Change of climate Sleep disturbances (insomnia, night-waking, upsetting dreams, poor sleep) Use of electric blanket Change of room temperature New thermometer Hot tubs Suana Bikram yoga Other Tap on Select to select the factor. You can add more than one factor. Tap on the + to add additional factors that you were exposed to. Version: 06/10/2015 Page 16 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Screen with the list of all factors will appear. Tap on the Factor that you were exposed to. Tap on My Diary to return to My Diary Screen. The App will save your selection. If a factor that you were exposed to is not listed in the list of Factors, you can enter a new factor. In the list of Factors, Tap on other. Enter Factor you were exposed to. Version: 06/10/2015 Tap on Other Page 17 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Enter the factor that you were exposed to. Click on return, the App will save the factor. Tap Save to save your Factors. URINARY LUTEINIZING HORMONE (LH) MEASUREMENTS AND RECORDING INSTRUCTIONS Use the LH detection kit provided to you for this study. Follow all other instructions as provided in the LH kit. Start on DAY 8 of your cycle; Using the first day of bleeding or spotting as Day 1 of your period, count forward 8 days to begin LH testing. Do not wait until next cycle. On day 8 of your cycle, start self-testing with the LH kit twice a day, in the morning and in the evening. Day 1 Period Starts Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Start LH Testing 2 Times per Day Record Your LH Result Starting Day 8 of your cycle, in the App please record the following:

Is LH surge detected?

If NO, LH surge is not detected:

Record the time you tested your urine. Continue testing at the same time twice per day. Version: 06/10/2015 Page 18 of 42 Protocol No: PT-001 TempuRing User Manual If YES, the LH surge is detected:

Prima-Temp, Inc Version: 1 Turn LH Surge Detected on. Record the time you tested your urine. Once your LH surge has been detected, call your study coordinator to schedule a visit for blood draw and ultrasound. There is no need for further testing during this cycle. If you have not detected an LH surge by Day 16 of your cycle, call your study coordinator to schedule a follow up visit.

[Add the Study Coordinator name and phone number to call]

LH Surge Detected - NO Time LH tested 1st time LH Surge Detected - YES Time LH tested 2nd time 3 INSTRUCTIONS FOR TEMPURING USE Read these Instructions for Use before you start using TEMPURING. TEMPURING should be inserted on the last day of your menstrual period (i.e. the day after you stop menstrual bleeding). Version: 06/10/2015 Page 19 of 42 Protocol No: PT-001 TempuRing User Manual Turn on Bluetooth on your iPhone/iPod Prima-Temp, Inc Version: 1 Go to Settings on your iPhone/iPod. Turn Bluetooth ON and Keep it On!

If you disable Bluetooth, the ring will be unable to transfer the temperature data to the App. If you disable Bluetooth, the App will show you an Error message and will show you Bluetooth Off on the device screen. If you received Bluetooth Off message, turn the Bluetooth ON. Tap on Ok Version: 06/10/2015 Page 20 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Bluetooth Off TEMPURING Pairing with iPhone/iPod Immediately before inserting TEMPURING, you must pair (connect) it with your iPhone/iPod and activate it (turn TEMPURING on). Go to TEMPURING App on your provided iPhone/iPod (See Device Pairing With App Screenshots below.) Tap on Main Menu (three small lines in the upper left of your screen) Tap on Devices. Tap on Scan for device. The App will start scanning for device. Version: 06/10/2015 Page 21 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tap on Main Menu Tap on Devices Version: 06/10/2015 Page 22 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tap on Scan for devices App will start scanning for Device TEMPURING Activation After the App starts scanning for device, immediately open the TEMPURING box. NOTE: Save the TEMPURING box as you will be returning TEMPURING to your study coordinator in the same box when you are finished using it. Carefully remove TEMPURING from the package. Locate the BLACK DOT on TEMPURING this marks the on/off switch. Version: 06/10/2015 Page 23 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Place TEMPURING into the cradle with the BLACK DOT facing down (see Turn TEMPURING ON image below.) Turn TEMPURING ON The App will automatically enter Pairing Mode. The App will ask you to enter the code. Enter 1. Tap on Pair. Enter 1 Version: 06/10/2015 Page 24 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Once TEMPURING and iPhone/iPod are paired, the message Active Ring will appear. The App we will ask you for permission to send you notifications. Click Ok. Take TEMPURING out off the cradle. Once the Ring is activated, the message Active Ring will appear. Inserting TEMPURING TEMPURING should be inserted into the vagina on the day after menstruation ends (when your menstrual bleeding has ended). Step 1. Choose a position for insertion of TEMPURING You can choose whichever position is most comfortable for you. For example, standing with one leg up on a chair, or lying down, or squatting (see Figure below). Version: 06/10/2015 Page 25 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Step 2. Prepare TEMPURING for insertion Prior inserting TEMPURING, wash and dry your hands. Place one finger near the black dot (the on/off switch) and the other finger on the other side of the ring. Gently press on the ring to make it lightly folded (an oval shape). Step 3. Insert TEMPURING into your vagina Insert the folded TEMPURING into your vagina and gently push it further up into your vagina using your index or middle finger. If you find that TEMPURING is dry to insert, apply a very small amount of standard water-based lubricant for vaginal use or fertility-friendly lubricant such as Pre-seed. DO NOT use gels with warming or cooling additives. TEMPURING may move around slightly in your vagina. This is normal. Version: 06/10/2015 Page 26 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 If you feel discomfort, TEMPURING is probably not fully inserted. Just use your finger to gently push TEMPURING further into your vagina. Step 4. Removing TEMPURING TEMPURING should remain inserted from the last day of the menstrual cycle until the start of your next menstrual cycle (first day of your menstrual bleeding). Before removing TEMPURING, wash and dry your hands. Choose the position that is most comfortable for you, for example, standing with one leg up on a chair, or lying down, or squatting (see above images, step 1). Put your index or middle finger into your vagina and hook it through TEMPURING. Gently pull downward to remove TEMPURING. Version: 06/10/2015 Page 27 of 42 Protocol No: PT-001 TempuRing User Manual Step 5. Used TEMPURING Prima-Temp, Inc Version: 1 Wash your used TEMPURING with soap and cool to warm water and dry it. Place TEMPURING in the box that it was provided in. Bring your used TEMPURING to your study doctor. DO NOT throw TEMPURING in the trash or toilet. 4 TEMPERATURE DATA TRANSFER It will take about 3-4 hours for the first temperature transfer to take place as TEMPURING warms to your body temperature. Do NOT kill (turn off) your App. As soon as the data transfer is complete, you will see near Last Sync Date and Time when the data were transferred and the Export Data text will appear (see Data Transfer Screenshots below). Data Transfer Screenshots Last sync Not yet Version: 06/10/2015 Page 28 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 After the initial 3 - 4 hours after activation and insertion, Last sync will show Date and Time. Once the Data are transferred, the Export Data text will appear 5 TEMPERATURE DATA SENT TO YOUR IPOD/IPHONE It is best to keep your iPod/iPhone within 8 feet of you as often as possible so the temperature data from the TEMPURING can be easily transmitted to your App. If you are separated from your iPod/iPhone by a range of 8 feet or more, the temperature data may not be transferred to your iPod/iPhone. However, the data will be transmitted the next time you are within range of your iPod/iPhone if it is within 2-3 days. If you have not received a successful data transmission in 24 hours, you will receive an alert on your App. Please refer to notification section below. 6 REPORTS TO SPONSOR You will be asked to export / email three (3) sets of data from your app to the Study Sponsor on a weekly basis: the My Diary report, the TEMPURING temperature data report, and the TEMPURING Logs. My Diary Data Reports (1) You will be expected to export and email My Diary weekly to your study sponsor. The study coordinator or study nurse will review and export all your cycle data in My Diary and will email this Report to the study sponsor at the end of each cycle visit. Version: 06/10/2015 Page 29 of 42 Prima-Temp, Inc Version: 1 Protocol No: PT-001 TempuRing User Manual To export My Diary Report:

Tap on Main Menu Tap on Cycles Tap on Current Cycle Tap on Email Data at the bottom of the screen The App will open up an email screen Tap on Send The App will send the email to the study sponsor Tap on Current Cycle Version: 06/10/2015 Page 30 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tap on Email Data An email screen will appear. Tap on Send. The App will email your Diary Data to Sponsor. TempuRing Temperature Data Reports (2) You will be expected to export and email TEMPURING temperature data weekly to your study sponsor. The study coordinator or study nurse will email all your TempuRing Temperature Data to the study sponsor at the end of each cycle visit. To email TempuRing Temperature Data to Sponsor:

Version: 06/10/2015 Page 31 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tap on Main Menu Tap on Device Tap on Export Data The App will open up an email screen Tap on Send The App will send the email to the study sponsor Tap on Main Manu Tap on Devices Version: 06/10/2015 Page 32 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tab on Export Data An email screen will appear. Tap on Send. The App will email your Temperature data to Sponsor. TempuRing App Logs Reports (3) You will be expected to export and email TEMPURING App Data Logs weekly to your study sponsor. The study coordinator or study nurse will review, export, and email all your TempuRing App Data Logs to the study sponsor at the end of each cycle visit. Version: 06/10/2015 Page 33 of 42 Protocol No: PT-001 TempuRing User Manual To email TempuRing Data Logs to Sponsor:

Prima-Temp, Inc Version: 1 Tap on Main Menu Tap on Device Tap on Logs The App will open up an email screen Tap on Send The App will send the email to the study sponsor Tap on Main Menu Tap on Devices Version: 06/10/2015 Page 34 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 To email Logs, Tap on Logs An email Screen will appear. Tap on Send. The App will email Logs to Sponsor. Multiple Devices The TEMPURING App can only communicate with one ring at a time. To add a new ring to the App, you must first forget the currently active ring. This can be done by:

Tap on Main Menu Tap on Device Tap on Forget Device Version: 06/10/2015 Page 35 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 To activate the new device, please refer to TEMPURING Pairing and Activation with iPhone/iPod section above. Only after you have used multiple rings, you will be able to see data from the previous TEMPURINGS. If you need to export the collected data from previously-used rings:

Tap the Down Arrow and switch between devices. The ring that you are currently looking at will have a checkmark next to it. Tap on the ring that you want to export the data. Tap on Forget Device Version: 06/10/2015 Page 36 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tap on Down Arrow The ring that you are currently looking at will have a checkmark next to it. Tap on the ring that you want to export the data. Notifications Once you successfully connect a ring to the App for the first time, the App will ask you for permission to send you notifications. Select OK. The App alerts you when you have NOT had a successful temperature transmission in 24 hours. The alert will display the alert, Your device has not synced in 24 hours. Version: 06/10/2015 Page 37 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 Tap on OK 7 FAQS:

How should I Use TEMPURING?

Read the Instructions for TEMPURING Use for detailed instructions about the right way to use TEMPURING. How do I wear TEMPURING?

TEMPURING is for vaginal use only. What if I dont use TEMPURING for the whole time period?

You may stop using TEMPURING whenever you wish. Please contact your study coordinator if you do stop using TEMPURING. How long should I wear TEMPURING?

TEMPURING is used in 4 week cycles (approximately 28 Days). Once you have inserted TEMPURING, it should not be removed, stored, and then used again for later cycles. After activation, TEMPURING will only remain active for one cycle approximately 28 Days. It cannot be turned off then turned on again. Version: 06/10/2015 Page 38 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 If TEMPURING has been left inside your vagina for more than 4 weeks

(approximately 28 days), TEMPURING will be deactivated and will no longer collect or transmit temperature recordings. The TEMPURING App will alert you that it is time to remove TEMPURING. If TEMPURING has been out of your vagina more than one day, you may not receive accurate temperature readings. Do not use more than one (1) TEMPURING ring at a time. How Should I clean TEMPURING The TEMPURING ring is provided clean. DO NOT clean TEMPURING in disinfectants or alcohol, or with antibacterial or disinfectant wipes. If you need to wash the TEMPURING, wash it with a mild, unscented, hand soap

(Ivory hand soap) for 30 seconds and then rinse in warm water for 30 seconds (

please refer to section Expulsion and Partner Discomfort below.) Can I sterilize TEMPURING using sterilizing solutions?

No. TEMPURING material is designed from specific biocompatible materials that prevent the growth of bacteria, and simple washing with soap and water is sufficient to maintain this material properly. Use of sterilizing solutions, alcohol wipes or sanitizing gels may damage the ring material. What are the restrictions on using birth control, yeast infection treatments, and tampons while using TEMPURING?

While using TEMPURING, you should not use a vaginal diaphragm as a method for birth control because TEMPURING may interfere with the correct placement and position of a diaphragm. Use of spermicides will not stop TEMPURING from working. You should not be wearing TEMPURING during your menstrual bleeding, so tampons will not be used at the same time that you are wearing TEMPURING. If you are undergoing treatment for a yeast infection or an STI, you should not use TEMPURING. If you suspect you have an infection or condition, you should stop using the TEMPURING and consult your study coordinator immediately. Wait until all symptoms have cleared and treatment finished before starting to use TEMPURING again. Version: 06/10/2015 Page 39 of 42 Protocol No: PT-001 TempuRing User Manual What are the possible side effects of TEMPURING?

Prima-Temp, Inc Version: 1 TEMPURING and is made of the highest medical grade materials already used in a number of other approved medical devices. In addition, TEMPURING has undergone extensive biocompatibility and toxicity testing and passed all of these tests. It therefore should cause no irritation, and nor should it increase the chances of infection. If you notice any signs of irritation or infection, you should stop using TEMPURING and contact your study coordinator immediately. TEMPURING is for your personal use. DO NOT share it with other women, as this may present a risk of infection, and invalidate your personal results. Talk to your healthcare provided about any side effects. The possible side effects of TEMPURING may include:

Vaginal Infection Vaginal infections should be treated with appropriate antimicrobial therapy before initiation of TEMPURING. If a vaginal infection develops during use of TEMPURING, then TEMPURING should be removed and reinserted only after the infection has been appropriately treated. Ring Removal Difficulty In rare occasions, the ring may adhere to the vaginal wall, making ring removal difficult. Vaginal wall ulceration or erosion should be carefully evaluated. If an ulceration or erosion has occurred, consideration should be given to leaving the ring out and not replacing it until healing is complete in order to prevent the ring from adhering to the healing tissue. Toxic Shock Syndrome (TSS) Although TEMPURING is not made of highly-absorbable material, Toxic Shock Syndrome is a rare condition caused by the bacterium Staphylococcus aureus growing on blood or fluids in the vagina. Some of the symptoms are much the same as the flu, but they can become serious. STOP using TEMPURING immediately and call your healthcare provider right away if you have the following symptoms:

a sunburn-like rash diarrhea dizziness 1020F or 390C muscle aches sudden high fever (above fainting or feeling faint when standing up vomiting Expulsion TEMPURING can be accidentally expelled, for example during intercourse, or with straining during a bowel movement. TEMPURING should be left in the vagina for a continuous period of 28 Days. If the ring is accidentally expelled, Version: 06/10/2015 Page 40 of 42 Protocol No: PT-001 TempuRing User Manual Prima-Temp, Inc Version: 1 wash the TEMPURING with mild, unscented, hand soap (Ivory hand soap) for 30 seconds and then rinse in warm water for 30 seconds (See Steps 1 through 3 above). Partner Discomfort If your partner experiences any discomfort from TEMPURING (e.g. penis discomfort or irritation), TEMPURING can be removed during intercourse and reinserted after intercourse. If the ring was removed during intercourse wash the TEMPURING with mild, unscented, hand soap (Ivory hand soap) for 30 seconds and then rinse in warm water for 30 seconds, and insert it again right away after intercourse (See Steps 1 through 3 above). Tampon Use You should not be wearing TEMPURING during your menstrual period, so tampon use should not take place at the same time that youre wearing TEMPURING ring. Other Possible Side Effects Foreign body sensation, Tissue irritation inside your vagina or cervix, Vaginal discharge, Vaginal discomfort, These are not all the possible side effects of TEMPURING. Tell your study coordinator about any side effects. How should I store TEMPURING?

Store TEMPURING at room temperature between 68-122 Fahrenheit (20 50 Celsius). Store TEMPURING for up to 2 years after you receive it. The TEMPURING App contains information about TEMPURING battery life, and informs you if the battery has expired. TEMPURING will record your temperatures between 94.1-104.9 Fahrenheit

(34.5C - 40.5 Celsius). DO NOT expose TEMPURING to temperatures above 122 Fahrenheit (such as boiling hot water). Keep TEMPURING out of the reach of children. Version: 06/10/2015 Page 41 of 42 Protocol No: PT-001 TempuRing User Manual How is TEMPURING Supplied?

Prima-Temp, Inc Version: 1 Each TEMPURING Ring is individually packaged in a TEMPURING box, with a User Manual included. What if I miss my regularly scheduled period when using TEMPURING?

Consider the possibility that you may be pregnant. Consider a visit with your healthcare provider for a pregnancy checkup. Can I have sexual intercourse while wearing TEMPURING?

The use of TEMPURING should not prevent you from having sex as frequently as you wish. Having sex will not affect the temperature recordings or recordings. You DO NOT need to remove TEMPURING before sex. Note: if either you or your partner finds that intercourse with TEMPURING is uncomfortable, you may remove TEMPURING during intercourse and reinsert it after intercourse. Wash the TEMPURING with mild, unscented, hand soap (Ivory hand soap) for 30 seconds and then rinse in warm water for 30 seconds and insert it again right away (See Steps 1 through 3). Can I started using TEMPURING later and not on the first day after my period stopped?

No. Wait for next cycle. To prevent loss of continues temperature monitoring efficacy, you should not deviate from the recommended regimen. Ideally, TEMPURING should be left in the vagina for a continuous period of 28 days. What should I do if TEMPURING is damaged or lost?

If your TEMPURING is not working or is damaged, you should contact your study coordinator to receive a new TEMPURING. Bring your used TEMPURING to your doctors visit. Can I give TEMPURING to a friend?

No. The ring is for your personal use. Sharing it with other women may present a hygiene risk, and will invalidate your personal data. Version: 06/10/2015 Page 42 of 42