Use Instructions

Personal Fertility Sensor
Instructions for Use
Version B
Dear User,
Thank you for choosing the Priya™ Fertility Sensor System (also known as Priya™).
The Priya System personal fertility sensor automatically, continuously, and eortlessly measures your core body temperature via a temperature sensor (referred to
as the Priya Sensor). The sensor transmits temperature data wirelessly to the Priya App (software application) on your mobile device.
We wish you the best on your fertility path forward.
Your friends at Prima-Temp, Inc.
This Instructions for Use (IFU) document provides information and instructions which must be followed to ensure safe performance of your Priya System. This IFU
also contains warnings and precautions which must be observed at all times.
Please read this IFU carefully and completely before opening and activating your Priya Sensor. In particular, please observe the directions for proper cleaning and
hygiene when inserting and removing Priya Sensor. If you have any questions, please contact our expert team at:
[e-mail]
www.Prima-Temp.com
1 Indication for Use
The Priya™ System is intended for continuously measuring and recording core body temperature as an aid in ovulation prediction to aid in conception.
2 Priya Components
The Priya System is delivered fully assembled and has two parts – the Priya Sensor (vaginal ring sensor) and the Priya App.
The Priya Sensor consists of a flexible Printed Circuit Board (PCB) assembly. It is battery powered by four independent 1.55V Silver Oxide batteries. The PCB
assembly is embedded in medical grade silicone. The Priya Sensor is intended for vaginal use only, where the maximum inserted outer diameter of the Priya Sensor
is 57 mm.
The Priya App will store all your cycle information and temperature data.
The Priya App can be used with iOS 11 or Android™8.0 or higher. Preferably, the most recent version of either operating system should be used to ensure all
features and capabilities are compatible.
Figure 1: Priya™ System
Priya App Priya Sensor
3 Safety Information
The Priya System is a Class IIb device according to the classification in the Council Directive 93/42/EEC for medical devices. Priya is intended to be used
continuously for a short-term duration (less than 30 days). Please see the list below for applicable regulatory guidance.
• Directive 93/42/EEC for medical devices
with amendments by 2007/47/EC
• Subsidiary Legislation 427.44, Malta,
Medical Device Regulations, Legal Notice
210 of 2008
• ISO 13485:2016
• EN-60601-1, EN 60601-1-1, EN 60601-1-11 • ISO 80601-2-56 • FCC part 15, Subpart C
• FCC Part 2, RF Exposure Assessment • RSS-247 • RSS-102-RF Exposure Assessment
• EN 300 328 v2.1.1 • EN 62479 SAR/RF Exposure • EN 301-489-1 with EN 301 489-17
• R&TTE Council Directive 1999/5/EC • IEC 60086-1, 60086-2, 60086-5 • EU Battery Directive 2006/66/EC Amend
2013/56/EEE
This Instructions for Use document is available in a number of languages. Contact your local distributor should you require a copy of this documentation in another
language.
3.1 Environment of Use
The Priya System has been designed for use in the home environment.
3.2 Contraindications
THIS PRODUCT IS NOT TO BE USED FOR CONTRACEPTION
Do not use the Priya System:
° For other than its intended purpose, as described in this IFU.
° If you have known allergies to silicone, epoxy resins, and/or ethylene vinyl acetate (EVA)-copolymers.
° When using other intravaginal products such as diaphragms, tampons, and pessaries.
° During Menstruation. The Priya Sensor may remain in the vagina continually for a maximum of 29 days at a time. The Priya Sensor should be removed
when you are menstruating.
° If you have any underlying gynecological infections or during the active phase of any sexually transmitted infections (STIs).
° During the six-week postpartum period after childbirth. This should not be used if you are pregnant.
° For a minimum of six weeks after genitourinary or pelvic surgical procedures.
° If you have any urinary tract infections.
° If you have severe pelvic pain.
° If you use an Intrauterine Device (IUD) or any intrauterine system (IUS).
° The Priya System is a measurement system to aid in the determination of fertile phases, i.e., fertile days. The Priya System is not a substitute for
individual measures or methods of pregnancy prevention (e.g., condoms). If you do not wish to become pregnant, you must use the contraceptive
method or methods of your choice.
° Do not use the Priya Sensor for protection against pregnancy or sexually transmitted infections (STIs).
° If signs or symptoms of an active vaginal infection are present, such as abnormal discharge, itching, discomfort or pain, the Priya Sensor should not be
used until such conditions have been successfully diagnosed and treated. If you suspect you have a vaginal infection, you should stop using the Priya
Sensor and consult your healthcare provider immediately.
° Using the Priya Sensor during active symptoms of any pelvic condition, such as a sexually transmitted disease (STD), herpes, yeast infection, or
vaginitis may cause increased discomfort or worsen symptoms.
° If you experience discomfort or have a concern about its use, stop use immediately and contact your healthcare provider.
• The Priya Sensor is not intended to be used by children, e.g., anyone under 18 years of age.
• The Priya Sensor should not be used by women with abnormal genital bleeding, prolapsed uterus, or vaginal infection.
• The Priya Sensor 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.
3.3 Warnings
• The Priya Sensor is intended to be used for up to 180 days. After the last cycle, the Priya Sensor should be disposed of according to the disposal section of
this IFU.
• The Priya Sensor should not be used during your menstrual period.
• Before insertion and after removing the Priya Sensor from the body, the Priya Sensor should be examined for any visible defects and/or changes. Do not use
the Priya Sensor if you detect any defects and/or changes. Contact Customer Service for more information and/or a replacement device.
• Do not drop the Priya Sensor; dropping may cause mechanical damage to the device. If the Priya Sensor is dropped, it should be inspected for visible
damage. The Priya Sensor should always be cleaned and disinfected prior to use.
• The Priya Sensor should not be used after the Use By date has expired.
• The Priya System is not suitable for direct temperature measurements and should not be used for temperature measurement for fever detection.
• Do not use any other auxiliary means to insert or remove the Priya Sensor.
• Choking hazard: Keep the Priya Sensor out of the reach of children and animals. Mishandling may cause mechanical damage to the device.
• The Priya Sensor should be removed if you are undergoing an MRI, CT, PET, or X-ray examination.
• The Priya Sensor should be removed prior to passing through security areas, such as airport security.
• DO NOT use more than one Priya Sensor at a time. While using the Priya Sensor, you should not have any other products or devices inserted into your
vagina.
• DO NOT insert the Priya Sensor anywhere other than your vagina.
• Always wash your hands thoroughly with soap and water and dry well after handling the Priya Sensor.
• During sexual intercourse or a bowel movement, the Priya Sensor may shift out of place. You should routinely check that the Priya Sensor is in the correct
position.
• Ensure that your software is up to date. Prima-Temp may issue software updates to improve the performance of the system and to introduce new features.
• Electromagnetic interference from other electrical equipment (such as an antenna) might interfere with the data transfer of the device, and you may not be
able to obtain your fertile window prediction.
• Electromagnetic interference while the device is in use might aect other electrical equipment, such as radios, Wi-Fi-connected equipment, etc.
3.4 Possible Side Eects
T
alk to your healthcare provider about any potential side effects you might experience with the Priya Sensor. You should also report any adverse events
to Customer Service. See Section 14 below for Customer Service contact details. Possible side effects may include:
• Vaginal Irritation – The Priya Sensor is made of durable, medical grade non-absorbent silicone. It should not irritate the inside of your vagina if cleaned and
cared for properly. If at any time during your use of the Priya Sensor you experience any discomfort, discontinue use and contact your healthcare provider.
• Vaginal Sensitization – One could have a sensitivity to any substance, but it is extremely rare to have a sensitivity to silicone. Studies indicate that silicone
is biocompatible with the body. This is why silicone has been used in healthcare applications for over 50 years. If you do experience skin sensitivity,
immediately discontinue use and contact your healthcare provider.
• Vaginal Infection – Vaginal infections should be treated with appropriate antimicrobial therapy before using the Priya System. If a vaginal infection
develops during use of the Priya System, then the Priya Sensor should be removed (see Section 5.9), and you should contact your healthcare provider.
• Sensor Removal Difficulty – In rare occasions, the Priya Sensor may adhere to the vaginal wall, making the Priya Sensor 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 Priya Sensor out
and not replacing it until healing is complete in order to prevent the Priya Sensor from adhering to the healing tissue.
If you are unable to remove your Priya Sensor, don’t panic. Refer to the instructions for sensor removal in this IFU (Section 5.9 “Removing and Turning Off the
Sensor” and Frequently Asked Questions at priyafertility.com). It may also be helpful to bear down (like when you are having a bowel movement) to assist with
sensor removal. If you continue to have difficulty, call your healthcare provider and schedule an appointment.
Note:
it may help to use water-based lubrication gel on your finger for sensor removal.
• Toxic Shock Syndrome (TSS) – Although the Priya Sensor is not made of a highly-absorbable material; Toxic Shock Syndrome is a rare condition caused by
the bacterium Staphylococcus aureus growing on blood or fluids in the vagina. For this reason, the Priya Sensor should not be worn during your menstrual
period. Some of the symptoms are much the same as the flu, but they can become serious. STOP using the Priya Sensor immediately and call your healthcare
provider right away if you have the following symptoms:
° sudden high fever (above 102°F or 39°C)
° a sunburn-like rash
° diarrhea
° muscle aches
° dizziness
° vomiting
° fainting or feeling faint when standing up
• Expulsion – the Priya Sensor can be accidentally expelled, for example during intercourse, or with straining during a bowel movement. If the Priya Sensor is
accidentally expelled, wash your hands, and clean the Priya Sensor according to cleaning instructions (see Section 4) before you re-insert.
• Partner Discomfort – if your partner experiences any discomfort from the Priya Sensor (i.e., penis discomfort or irritation), the Priya Sensor can be removed
during intercourse. If the Priya Sensor was removed during intercourse, clean according to cleaning instructions (see Section 4) before you re-insert. To
achieve the most accurate fertile window prediction, the sensor should be re-inserted as soon as possible (within 1-2 hours).
• Tampon Use – you should not be wearing a Priya Sensor during your menstrual period, and therefore, you should not be using a tampon at the same time
that you’re wearing the Priya Sensor.
• Other Possible Side Eects – this includes foreign body sensation, tissue irritation inside your vagina or cervix, vaginal discharge, and vaginal discomfort.
Should you have any concerns about allergies, please consult your physician or dermatologist.
3.5 Storing and Handling the Priya Sensor
• DO NOT expose the Priya Sensor to temperatures above 55° Celsius or 131° Fahrenheit (such as boiling hot water or microwave).
• To avoid device damage and maintain cleanliness, store the Priya Sensor in the provided package and out of direct sunlight when not in use. Keep the Priya
Sensor away from children and pets.
• The Priya Sensor may discolor for various reasons, including exposure to Benzophenone-2, a chemical commonly found in sunscreen and beauty products
containing sunscreen. Always be sure to wash your hands before handling the Priya Sensor. If discoloration occurs, contact Customer Service. See Section 14
below for Customer Service contact details.
• Silver Oxide batteries are not listed as dangerous goods under the ADR European Agreement Concerning the International Carriage of Dangerous Goods
by Road, the IMDG International Maritime Dangerous Goods Code, UN Dangerous Good Regulations, IATA Dangerous Goods Regulations, ICAO Technical
Instructions and the U.S. hazardous materials regulations (49 CFR).
• Ground Transport (US DOT): 49 CFR 172.102 Provision 130
• Air Transport (IATA): Special Provision A123
• Marine/Water Transport (IMDG/ICAO): Provisions 295 and 304
3.6 Device Life Expectancy
The device’s life expectancy is dependent on the batteries in the Priya Sensor. It has a life expectancy of 180 days once the device is initially activated (provided
the 180 days is complete prior to “Use By” date). It is recommended that the Priya Sensor is turned o between uses to conserve battery life.
3.7 Disposing and Recycling the Priya Sensor
The Priya Sensor should NOT be disposed of with household waste. To ensure the correct waste treatment of the product, please dispose of the sensor in
accordance with any applicable local laws or requirements for disposal of electrical equipment. In doing so, you will help to conserve natural resources and improve
standards of environmental protection in treatment and disposal of electronic waste.
4 Cleaning and Disinfecting the Priya Sensor
We recommend that you clean and disinfect your Priya Sensor prior to insertion, and after each time it is removed.
Cleaning and disinfecting are not the same thing. Cleaning simply removes macroscopically visible contamination. Disinfecting kills germs and provides an extra
level of safety. Some germs can live on surfaces for hours and even for days! You should follow the disinfection process provided as it has been shown to be
eective in destroying dangerous bacteria and viruses.
The exterior of the Priya Sensor should only be cleaned and disinfected with a product such as DISPATCH Hospital Cleaner Disinfectant Towels™ or Oxivir Tb
Wipes™ which have been tested and shown to be safe and eective. We recommend using DISPATCH towels (or another wipe that contains the active ingredient
0.65% of sodium hypochlorite) or Oxivir Tb Wipes (or another wipe that contains 0.5% accelerated hydrogen peroxide (AHP)). In the following procedure, the first
disinfectant towel is used for cleaning and the second towel disinfects the Priya Sensor.
Warnings for cleaning and disinfecting:
• Do not use any glass or household cleaners on the device.
• Do not put the device in the dishwasher or in the microwave.
• DO NOT BOIL the device.
• Stop using the device and contact customer service immediately if you notice any of the following signs of deterioration:
−The device does not turn on or o.
−There is a change in color, or the device appears to be damaged.
Clean and disinfect the Priya Sensor with the disinfectant towels according to the following instructions.
Cleaning and disinfecting the Priya System:
1. Wash your hands.
4. Discard used towel according to the
instructions provided with the disinfectant
towel.
2. Dispense the disinfectant towel from its
package or container.
5. Dispense a second disinfectant towel from
its package or container.
3. Clean the entire surface of the Priya Sensor
to remove any blood, dirt or vaginal discharge
with one disinfectant towel.
6. Disinfect the Priya Sensor with the
second towel by wiping all outside surfaces
thoroughly according to the instructions
provided with the disinfectant towel.
Figure 2: Creating an Account Figure 3: Entering Basic Info
STEP 3: Complete information on the Basic Info page and tap “Save” (refer to Figure 3)
You
have now completed setting up the Priya App and you will arrive at the Home screen. You won’t need to do anything more until your next period starts! Note:
if you’re currently on your period, you can begin using the sensor on the day your period ends, or within 24 hours.
5.2 Your First Menstrual Cycle
STEP 1: From the Home screen, tap “Set Period Start” on the day your period starts and use the selector to select the start date.
Note: if you’re currently on your period, you will enter the historical day that your period began.
STEP 2: Allow notifications when prompted – this is necessary for you to receive notification of your fertile window. If you accidentally disallow notifications, you
may update your notification preferences in the phone app settings.
STEP 3: When your period ends, tap “Set Period End” and use the selector to select the end date.
Note: If you need to adjust your period start or end dates, tap the corresponding date on the Calendar tab which reveals an edit button to modify the dates.
STEP 4: On the day your period ends (or within 24 hours), pair your sensor as described in Section 5.3.
Note: Do not insert the Priya Sensor until after you have paired the Priya Sensor with the Priya App and have seen a successful temperature reading in your app.
5.3 Turning On and Pairing the Priya Sensor with the Priya App
To preserve battery life and to obtain the most accurate results, the Priya Sensor should be activated, paired and inserted within 24 hours after your menstrual
period ends (refer to Section 5.6). The Priya Sensor will only work for 180 days after it is first activated, so the sensor should not be activated until you are ready
for insertion. The chart below details how to use the sensor and the LED light modes associated with each action.
I want to… Action to take LED light mode Notes
Turn the sensor on
and pair
Squeeze the power button
until the LED lights green
(about 1 second)
Green, followed
by breathing
blue
Breathing blue means the sensor is in pairing mode. When the sensor
is paired with the phone, LED turns o. If you do not pair, then after 30
seconds LED turns o and the sensor turns itself o.
Turn the sensor mode
to o
Squeeze the power button
until the LED lights purple
(about 3 seconds)
Turns purple
then fades o
Sensor will be o
Check if my sensor is
on and paired.
Squeeze and release the
power button
LED flashes blue The blue flash confirms that the sensor is on, and that it is paired.
Your phone should receive temperatures within a few seconds, which
confirms that the sensor is paired with the app on your mobile device.
Know when the
sensor life is over
None LED holds
orange for 3
seconds
If you press the button to turn the sensor on and the battery is too low
for use, the LED will hold orange for 3 seconds before the sensor turns
itself o.
Note: The Priya App will not let you pair the device if your period end date was more than 2 days ago.
1. Wash hands with warm water and soap before handling the Priya Sensor.
2. Have the Priya App opened on your mobile device.
3. Have your pairing code ready (displayed on the Priya Package).
4. Do not throw away the Priya Package. You will need it to reference the pairing code and to store the Priya Sensor between cycles.
7. Discard used towel according to the
instructions provided with the disinfectant
towel.
8. Wait at least one minute and make sure the
Priya Sensor is completely air dried before
inserting the Priya Sensor. Make sure that no
bubbles from the cleaning and disinfecting
agent remain.
9. If you’d like, you may rinse the Priya Sensor
under cool running water to clear any residual
disinfectant solution.
a) Tap ”Pair with Sensor” in the Priya App. This will make the app scan for a
sensor for 60 seconds.
b) TURN ON the Priya Sensor by squeezing the power button until the LED
lights green.
c) The LED will be green and then turn blue to indicate it is attempting to pair.
d) Enter the Pairing Code in the app if prompted. You will have 30 seconds to
enter the code before the Priya Sensor turns o.
e) Within a few seconds, the app will alert you that pairing was successful.
f) At this point, you may insert the Priya Sensor as described in Section 5.5.
Troubleshooting Note: if at any time during your cycle you become concerned
about whether or not the sensor and the app are still paired, you can remove the
sensor and perform an instant data transfer as described in the Troubleshooting
section.
Figure 4: Pairing the Priya Sensor and the Priya App
5.4 Priya Data Transfer
• Your temperature data will be visible on the ‘“Home” screen once the Priya App receives the first temperature reading.
• The app will not display temperatures immediately. The sensor reads a temperature every 6 minutes and sends them over Bluetooth® in groups of 10
readings, thus temperatures sync with the app hourly.
• The “Sensor” tab displays the time of your next expected temperature sync.
Remember:
• Once the Priya Sensor has paired with your mobile device, the Priya App MUST be running in the foreground or background. If the app is completely
closed, your data will not be transmitted, and you may miss your fertile window prediction.
• Keep Bluetooth on your mobile device on at all times – the Priya App cannot receive temperature information if Bluetooth is turned off.
• The Priya App must have access to Wi-Fi or mobile data to upload your temperature and cycle information to the cloud.
• T
o ensure the most accurate communication and data transfer from the Priya Sensor, it is best to keep your mobile device in close proximity to your body
during the expected sync times (e.g., in your front or back pocket or while you’re sleeping, on the nightstand next to your bed).
5.5 Inserting the Priya Sensor
To ensure an accurate fertile window prediction, you should insert the Priya Sensor on the day your period ends.
STEP 1: Disinfect Priya Sensor for first use – Refer to Section 4 for full cleaning and disinfection instructions.
STEP 2: Prepare Priya Sensor for insertion
1. Place your thumb next to the LED window and index finger across to compress the sensor
2. Gently press on the Priya Sensor to make it lightly folded into an oval shape (see Figure 5). DO NOT TWIST.
STEP 3: Choose a position for inserting Priya Sensor. You can choose a position that is most comfortable for you. For example, standing with one leg up on a chair,
lying down, or squatting (see Figure 6).
STEP 4: Inserting Priya Sensor into your Vagina
1. Insert the compressed Priya Sensor into your vagina and gently push it further into your vagina using your index or middle finger (see Figure 7).
2. The Priya Sensor may move around slightly in your vagina. This is normal.
3. If you feel discomfort, the Priya Sensor is likely not fully inserted. Use your finger to push the Priya Sensor further into your vagina gently.
4. If you find that the Priya Sensor is “dry” and you are having diculty inserting it into your vagina, apply a very small amount of standard water-based
lubricant for vaginal use or fertility-friendly lubricant. DO NOT use gels with warming or cooling additives; the lubricant should not contain a spermicide.
5. After insertion, clean and dry your hands.
Note: You can find both types of cleaning wipes through online retailers such as Amazon.com
5 How to Use the Sensor and App
The Priya Sensor is a flexible vaginal ring that is self-inserted at home. It is for vaginal use only. The Priya Sensor automatically and continuously measures your
core body temperature via a temperature sensor inside of the silicone ring. The sensor transmits temperature data wirelessly to the Priya App (called ‘Priya’)
on your mobile device, where temperature data points are collected. The Priya App must be running (in the foreground or background) in order to collect your
temperature data.
Once activated, each Priya Sensor is designed to be used for up to 180 days from initial activation. The Priya Sensor should be inserted on the same day that your
period ends or within 24 hours after your period ends (see Section 5.5). After the cycle is complete or 29 days have elapsed (whichever comes first), the sensor is
removed and cleaned according to cleaning instructions (see Section 4).
5.1 Setting Up the Priya App
Before you can use the Priya Sensor, you will have to set up the Priya App on your mobile phone.
STEP 1: Download the Priya App to your iOS or Android mobile phone.
1. Go to the Apple App Store or Google Play store and search for ‘Priya Fertility.’
2. Download the Priya App.
3. If you have already downloaded the App, then please make sure you have the latest version by checking Updates on your mobile device.
STEP 2: Open Priya App & Create an Account (see Figure 2).
1. Enter your first and last name.
2. Enter your email.
3. Create a password (password must be at least six characters).
4. Tap on “Create Account” at the bottom of the screen.
5. Read and acknowledge the Terms of Use and Privacy Policy.
6. Provide your voluntary consent to the processing of your personal data we will collect from you, if you agree.
Note: If you do not provide consent or withdraw your consent, we will not be able to provide you with fertility predictions. The withdrawal of your consent will not
aect the lawfulness of the prior data processing activities. If you decline the Terms of Use, you will not be able to use the app and your account will be deleted.
Also note that you can access the Privacy Policy and Terms of Use at any point in the app by clicking on the Account tab.
Figure 5: Prepare the Priya Sensor for Insertion
Figure 6: Choose a Position Figure 7: Inserting the Priya Sensor