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TempuRing
Personal Fertility Sensor
User Manual
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Protocol No: PT-001 Prima-Temp, Inc
TempuRing User Manual Version: 1
Version: 06/10/2015 Page 2 of 42
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 corn e r, a nd clicking on ‘About’.
Caution: changes or modifications not expressly approved by Prima-Temp, Inc could void the
user's authority to operate the equipment.
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Protocol No: PT-001 Prima-Temp, Inc
TempuRing User Manual Version: 1
Version: 06/10/2015 Page 3 of 42
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 App’s ‘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!
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6! REPORTS TO SPONSOR ..................................................................................... 29!
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 don’t 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!
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Protocol No: PT-001 Prima-Temp, Inc
TempuRing User Manual Version: 1
Version: 06/10/2015 Page 5 of 42
Manufacturer
Prima-Temp, Inc.
2820 Wilderness Place, Suite C
Boulder, Colorado 80301
United States
1-866-398-1032
www.Prima-Temp.com
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Protocol No: PT-001 Prima-Temp, Inc
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Version: 06/10/2015 Page 6 of 42
1 TEMPURING DESCRIPTION
TEMPURING personal fertility sensor consists of a flexible vaginal ring that is selfinserted 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
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2 INSTRUCTIONS FOR MEASURING AND RECORDING ORAL
TEMPERATURE, FACTORS THAT MAY AFFECT TEMPERATURE,
AND URINARY LH
The TEMPURING App’s ‘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’.
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• It will ask you to confirm your entry. Please confirm by clicking ‘sure’.
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’.
Enter Name
Enter Email address
Study Coordinator
enters subject ID
Enter Date of Birth
Tap on ‘Save’
Click on ‘Sure’ to
Confirm
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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.
Tap on add a Cycle
Select a Start Date of
your cycle and Tap
‘Save’
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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.
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’
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Tap on Main Menu
Tap on ‘Devices’ to go to
Device Screen
Tap on ‘Cycles’ to go to
Cycles Screen
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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’.
Device Screen
Cycles Screen
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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.
Tap on ‘Current Cycle’ to
see the ‘My Diary’ screen.
Tap on Date to navigate
from day to day.
My Diary Screen
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• 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 ‘Time Taken’ to
select the time you took your
oral temperature.
Tap on ‘Temperature’ to
record the oral temperature.
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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
Fever
2
Illness and infections (even those that do not produce a fever)
3
Cold, sore throat
4
Drugs and medications
5
Alcohol (especially in large quantities, though all alcohol consumption
should be recorded)
6
Smoking
7
Emotional stress
8
Physical stress
9
Excitement
Select the time you took
your oral temperature.
Select ‘AM.’
Tap on ‘Time Taken’ again.
Tap on ‘Save’
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Factor Table
Number
Factors May Influence Your Oral Temperature
10
Change in waking time
11
Jet lag
12
Travel
13
Change time zone
14
Change of climate
15
Sleep disturbances (insomnia, night-waking, upsetting dreams, poor sleep)
16
Use of electric blanket
17
Change of room temperature
18
New thermometer
19
Hot tubs
20
Suana
21
Bikram yoga
22
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.
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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.
Tap on the Factor that you were
exposed to.
Tap on ‘Other’
Screen with the list of all factors
will appear.
Tap on ‘My Diary’ to return to
My Diary Screen. The App will
save your selection.
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• 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.
Enter the factor that you were
exposed to.
Click on ‘return’, the App will
save the factor.
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If YES, the LH surge is detected:
• 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]
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).
LH Surge Detected - “YES”
LH Surge Detected - “NO”
Time LH tested 1st time
Time LH tested 2nd time
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Turn on Bluetooth on your iPhone/iPod
• 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’
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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.
Bluetooth Off
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Tap on Main Menu
Tap on Devices
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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.
Tap on ‘Scan for
devices’
App will start scanning
for Device
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• 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
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• 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.
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).
Once the Ring is
activated, the message
‘Active Ring’ will appear.
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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.
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• 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.
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Step 5. Used TEMPURING
• 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’
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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.
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
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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’
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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:
Tap on ‘Email Data’
An email screen will
appear.
Tap on ‘Send.’ The App
will email your Diary Data
to Sponsor.
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• 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 Devices
Tap on Main Manu
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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.
Tab on ‘Export Data’
An email screen will
appear.
Tap on ‘Send.’ The App
will email your
Temperature data to
Sponsor.
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To email TempuRing Data Logs to Sponsor:
• 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 Devices
Tap on Main Menu
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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’
To email Logs, Tap on ‘Logs’
An email Screen will
appear.
Tap on ‘Send.’ The App
will email Logs to Sponsor.
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• 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’
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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.”
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.
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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 don’t 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.
Tap on OK
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• 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.
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What are the possible side effects of TEMPURING?
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:
• sudden high fever (above
1020F or 390C
• a sunburn-like rash
• diarrhea
• muscle aches
• dizziness
• vomiting
• fainting or feeling faint when
standing up
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,
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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 you’re 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.
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How is TEMPURING Supplied?
• 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 doctor’s 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.
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