Figure 8: Removing the Priya Sensor
5.6 Priya Notifications
The Priya App may generate the following notifications during your active cycle.
• Fertile window – When the Priya App detects temperature variations that indicate imminent ovulation, you will receive a notification, and your fertile window
will be highlighted on the temperature graph on the “Home” screen.
• Reminder to clean sensor – If you are using the sensor for more than 28 days, you should temporarily remove it and clean it. You will receive a reminder to
do so.
• Sensor expiration – Based on your subscription, you will receive a notification when your Priya Sensor will soon expire and when it has expired. Once expired,
the sensor will no longer collect temperature data.
5.7 Priya Error Messages
• Sensor Failed to Pair – You will receive a pop-up alert if the sensor failed to pair. The pop-up alert will have instructions to re-attempt pairing your Priya
Sensor.
• App Failed to Find sensor – You will receive a pop-up alert if the app doesn’t discover the sensor during pairing. The pop-up alert will have instructions to
re-attempt pairing your Priya Sensor.
• Too long since Bluetooth sync – You will receive a notification that it has been too long since the app synced with the Priya Sensor.
• Temperature update without cloud sync – You will receive a notification that the Priya App received temperature data that was not successfully saved to the
cloud.
Note: Troubleshooting steps are in Section 11.
5.8 End of Cycle
Your cycle ends and a new one begins on the day your next period starts. At that time, you will need to remove and clean the Priya Sensor and enter your next
period start date in the Priya App by tapping the “Set Period Start” button. Add personal notes in the “Calendar” tab as often as you like, such as for luteinizing
hormone (LH) or pregnancy test results. This section is optional and for your personal use.
5.9 Removing and Turning O the Priya Sensor
You will remove the Priya Sensor when your period starts, for periodic cleaning (at least every 29 days), and for sexual intercourse if desired. You do not need to
turn o the sensor when you remove it for periodic cleaning and intercourse.
NOTE: If the Priya Sensor has been out of your vagina more than two hours during your cycle (when not on your menstrual period), it may aect the accuracy of
your fertile window prediction. Therefore, except for when you remove the Priya Sensor during your menstrual period, you should re-insert the Priya Sensor as soon
as possible after it has been removed.
STEP 1: Preparing to Remove the Priya Sensor
1. Before removing the Priya Sensor, wash and dry your hands.
2. 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 Figure 6).
STEP 2: Removing the Priya Sensor
1. Put your index or middle finger into your vagina and hook it through the Priya Sensor as shown (see
Figure 8).
2. Gently pull downward to remove Priya Sensor. See Frequently Asked Questions at www.priyafertility.com
if you have diculty removing the sensor..
STEP 3: Cleaning the Priya Sensor
1. Dispense the disinfectant towel from its package or container.
2. Clean the entire surface of the Priya Sensor to remove any blood or dirt with one disinfectant towel.
3. Discard used towel according to the instructions provided with the disinfectant towel.
4. Rinse the sensor under running water then dry the sensor completely.
STEP 4: Turning o the Priya Sensor
To TURN OFF the Priya Sensor, squeeze the power button until the LED lights purple (about 3 seconds).
STEP 5: Storing the Priya Sensor
Place the sensor in the storage case until it is ready to be used again for the next menstrual cycle. Be sure that the sensor is completely dry before putting it in the
case.
6 Additional Menstrual Cycles
For additional menstrual cycles, follow the instructions described in Section 5.3. The full cleaning and disinfection instructions in Section 4 should be completely
followed for all additional menstrual cycles.
7 Pairing Additional Sensors or Changing Sensors
The Priya App can only communicate with one Priya Sensor at a time.
If you are changing your sensor at a new cycle, simply follow the instructions to pair.
If you are changing your sensor mid-cycle, proceed to the “Sensor” tab, tap “Technical Data” to proceed to the “Technical Data” screen. Tap the “Unpair Sensor”
button then return to the “Home” tab and pair as instructed.
8 Show “Technical Data”
When contacting Customer Service, you may need to see Technical Data about your sensor and your app. This is displayed in the “Technical Data” page. To access
this data, tap the “Advanced” button on the “Sensor” tab, then click “Technical Data.”
9 Technical Specifications
WARNING: The Priya Sensor is not a serviceable part. In other words, modification, repair or change of the Priya Sensor is not possible and is forbidden by the
manufacturer.
Operating Ranges
Temperature: 5.0° to 40.5°C (41.0° to 104.9°F)
Temperature Measurement Range: 34.5° to 40.5°C ± 0.1°C (94.1° to 104.9°F ± 0.18°F)
Transient Response Time: 20 minutes (time for the device to raise/lower by 2°C)
Humidity: 10% to 100% relative humidity
Atmospheric pressure: 700 hPa to 1060 hPa
Ingress Protection: IP67 (Device is designed to protect against dust ingress and liquids up to 1m deep)
Electrical & Power Ratings
Electrical Specifications:
3.10V Silver Oxide Battery (Mercury free); 43mAh
Environmental
Use By: 30 months from the date of manufacture
Storage temperature range: -25°C to 55°C (-13°F to 131°F)
The relative humidity range: 10% to 90% non-condensing
Atmospheric pressure: 70 kPa to 106 kPa
Other Technical Specifications
Communication: Bluetooth
Bandwidth: 2.402 to 2.480 GHz
Data Modes: BLE (Bluetooth Low Energy)
ERP (Eective Radiated Power): 8.85 dBm
Output: Core body temperature readings, Priya App report
Priya Sensor Weight: 9.9 ± 2 g (0.35 ± 0.07oz)
Priya Sensor Dimensions: 57 mm OD, 38mm ID (2.24 in OD, 1.50 in ID)
Other Requirements
A mobile device with a stable connection to the Internet for downloading/installing software, registering Priya account, and uploading data to the secure cloud
server is required. The Priya Sensor will store approximately 30 days of temperature data; a stable Bluetooth connection is required to transfer data from your Priya
Sensor to the Priya App.
Prima-Temp recommends a mobile device with the following specifications:
• Operating System: iOS 11 or Android™ 8.0 or higher, preferably the most recent available version
• WiFi: Yes
• Bluetooth: Yes, 4.2 Bluetooth
• GPS: Yes
• Battery Size: 2500mAh minimum
• Number of Cells: 1
Note: An Internet connection is used to register the device, and to download/upload data to the cloud system. The Priya Sensor will store your temperature data for
approximately 30 days. Once the Priya App receives temperature data, your mobile device will store all of your temperature information within the Priya App.
10 Electro Magnetic Compatibility
The Priya Sensor requires special precautions regarding the EMC (Electro Magnetic Compatibility) and should be used according to the EMC information provided
in this IFU.
For EM compliance, it is important only to use accessories that meet the specifications recommended by Prima-Temp (Refer to Section 9).
Recommendations for actions to assure that the Priya System remains safe with regard to EM disturbances:
• If the Priya System is used in a location near (e.g., less than 1.5 km from) AM, FM, or TV broadcast antennas, it may be necessary to take preventative actions
for reducing the electromagnetic (EM) interfering level (for instance, by physically moving to a dierent location).
The Priya System contains Bluetooth wireless modules which intentionally receive and transmit RF electromagnetic energy in the 2.4 GHz ISM frequency band.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Priya System is intended for use in the electromagnetic environment specified below. The customer or user of the Priya System should assure that it is used
in such an environment.
When the Priya System is exposed to electromagnetic (EM) disturbances, the system may show abnormal behavior.
Emissions test Compliance
RF emissions
CISPR 11 Group 1
RF emissions
CISPR 11 Class B
Harmonic emissions
IEC 61000-3-2
Not
applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not
applicable
Rated maximum output power of the transmitter
W
0.01
0.1
1
10
100
Electromagnetic environment - guidance
The Priya System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
The Priya System is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Separation distance according to the frequency of the transmitter
m
150 kHz to 80 Hz
d=1.17√P
80 MHz to 800 mHz
d=1.17√P
800 MHz to 6 GHz
d=2.33√P
0.12 0.12 0.23
0.37 0.37 0.74
1.17 1.17 2.33
3.70 3.70 7.37
11.70 11.70 23.30
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic Discharge
IEC 61000-4-2
±8kV contact
±15kV air
±8kV contact
±15kV air
Not applicable – The device is intended to
be used internally.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Radiated RF
Immunity IEC
61000-4-3
3 V/m
80 MHz to 6 GHz
27 V/m
385 MHz
28 V/m
450 MHz
9V/m
710/745/780 MHz
28 V/m
810/870/930 MHz
28 V/m
1720/1845/1970 MHz
28 V/m
2450 MHz
9 V/m
5240/5500/5785 MHz
3 Vrms
Portable and mobile RF communications equipment should be used no closer to any part of
the Priya System than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d=1.17√P
d=1.17√P 80 MHz to 800 MHz
d=2.33√P 800 MHz to 6 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer and d is the recommended separation distance in meters (m).
The Priya System is fairly sensitive to radiated RF. Disturbances in data transfer are possible
at and below the specified test level. It may be necessary to move away from interfering
equipment.
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a
should be less than the compliance level in each frequency range. Interference may occur in
the vicinity of equipment marked with the following symbol:
Guidance and manufacturer’s declaration – electromagnetic immunity
The Priya System is intended for use in the electromagnetic environment specified below. The customer or user of the Priya System should assure that it is used
in such an environment.
When the Priya System is exposed to electromagnetic (EM) disturbances, the system may show abnormal behavior.
Recommended separation distances between portable and mobile RF communications equipment and the Priya Sensor
The Priya System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
Priya System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Priya System as recommended below, according to the maximum output power of the communications equipment.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to a part of the Priya System. Otherwise, degradation of the performance of this equipment could result.
Guidance and manufacturer’s declaration – electromagnetic immunity
The Priya System is intended for use in the electromagnetic environment specified below. The customer or user of the Priya System should assure that it is used
in such an environment.
When the Priya System is exposed to electromagnetic (EM) disturbances, the system may show abnormal behavior.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reflection from structures, objects, and
people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the Priya System is used exceeds the applicable RF
compliance level above, the Priya System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary.
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reflection from structures, objects, and
people.
11 Troubleshooting
11.1 If you cannot pair the Priya Sensor with the App:
1. Verify that Bluetooth is enabled on your mobile device.
2. Make sure you have the correct pairing code (displayed on the Priya Sensor packaging).
3. Verify that after depressing the power button the LED lights green then breathes blue. (If the LED lights green and then fades out, or does not light at all, the
battery life of your device has been depleted and your sensor will need to be replaced.)
4. Retry pairing the sensor and the app using the instructions in Section 5.3.
5. If you are still unable to successfully pair the devices, press the Priya Sensor power button for at least 10 seconds (this resets the sensor’s Bluetooth), and in
your phone Bluetooth settings’ list of known Bluetooth devices, remove any devices named “Priya-Ayola” (in iOS, removing the device is the “forget device”
action). Now, retry pairing using the instructions in Section 5.3.
If you still cannot get your devices to pair, contact Customer Service for further instructions at priyasupport@kindara.com.
11.2 If your Priya Sensor has not synced with the app for more than 12 hours, try the following options:
Note: The Priya Sensor stores at least 30 days of temperature readings until they are sent to the app, so there is no risk that you will lose temperatures. The only risk
is that a fertile window prediction may be delayed if temperatures are not received by the app.
1. Ensure that Bluetooth is enabled on your phone, and that the app is on (either in the foreground or background).
2. In the app’s sensor tab, ensure that “Sensor Status” is “Paired”. If not, you will need to pair your sensor as described in Section 5.3.
3. In the app’s sensor tab, select “Advanced" then "Technical Data” to view the Sensor’s Battery Level. This displays the battery level at the time of last
successful temperature transmission. If the battery level is below 10% your sensor battery may be too low to transmit.
4. In the app’s sensor tab, view the “Next Sensor Sync” time. Starting one minute before this time and continuing until a transmission is received, keep your
phone very near your abdomen. Some women find that the front or back pants pocket works well. (Once a sync occurs, you should see new
temperature readings in your temperature graph.)
5. Assisted Syncing: If you are still unable to sync with the sensor, try an “Assisted Sync.” To do this, first remove your sensor. Then depress the power
button for just one second to trigger a sync. (The LED should briefly light blue to indicate the sync.) Now look at your temperature graph to ensure new
temperatures were received, and clean and re-insert your sensor as you did when starting your cycle.
If
you
still
cannot
get
the
sensor
t
o
sync
with
the
app,
contact
Prima-
T
emp,
Inc.
Customer
Service
for
further
instructions
at
priy
[email protected] 12 Device Specifications and Symbols
Warning Labels/Safety Labels
Symbol Symbol Title Explanatory Text Standard Reference
Non Sterile Indicates a medical device that has not been subjected to a sterilization
process.
EN 980, ISO 15223-1, ISO 7000-2609
Use by Indicates the date after which the medical device is not to be used. EN 980, ISO 15223-1, ISO 7000-2607
Batch (Lot) Code Indicates the manufacturer’s batch code so that the batch or lot can be
identified.
EN 980, ISO 15223-1, ISO 7000-2492
Attention: Read
all warnings and
precautions in
instructions for use
Indicates the need for the user to consult the instructions for use and/
or user manual for important cautionary information such as warnings
and precautions that cannot, for a variety of reasons, be presented on
the medical device itself.
EN 980, ISO 15223-1, IEC 60601-1, ISO
7000-0434
Do not use if the
package is damaged
Indicates a medical device that should not be used if the package has
been damaged or opened.
ISO 15223-1, ISO 7000-2606
Consult Instructions
for Use
Indicates the need for the user to consult the instructions for use and/
or user manual.
EN 980, ISO 15223-1, IEC 60601-1, ISO
7000-1641
Date of Manufacture Indicates the date when the medical device was manufactured. EN 980, ISO 15223-1, ISO 7000-2497
Manufacturer Indicates the medical device manufacturer. EN 980, ISO 15223-1, ISO 7000-3082
Type BF applied part To identify a type BF applied part complying with IEC 60601-1. IEC 60601-1, IEC 60417-5333
Serial Number Indicates the manufacturer’s serial number so that a specific medical
device can be identified.
EN 980 Clause 5.5, ISO 15223-1 Clause
5.1.7, ISO 7000-2498
Catalog or model
number
Indicates the manufacturer’s catalog number so that the medical device
can be identified.
EN 980, ISO 15223-1, ISO 7000-2493
CE Marking Signifies European technical conformity. 765/2008/EC 768/2008/EC MDD
93/42/EEC Articles 4,11,12,17, Annex II
Authorized European
Representative
Indicates the Authorized Representative in the European Community. EN 980, Clause 5.13, ISO 15223-1,
Clause 5.1.2
Temperature Limit Indicates the temperature limits to which the medical device can be
safely exposed.
EN 980, ISO 15223-1, ISO 7000-0632
Humidity Limitation Indicates the range of humidity to which the medical device can be
safely exposed.
EN 980, ISO 15223-1, ISO 7000-0632
Symbol Symbol Title Explanatory Text Standard Reference
Atmospheric
Pressure Limitation
Indicates the range of atmospheric pressure to which the medical
device can be safely exposed.
EN 980, ISO 15223-1, ISO 7000-0632
Recycle Electronic
Equipment
DO NOT THROW IN TRASH. EN 50419
Bluetooth® wireless
or enabled
technology
Bluetooth® wireless or enabled technology. (Trademarks of Bluetooth Special
Interest Group (SIG)
Radio Frequency
Devices (U.S.)
Federal Communication Commission Number (FCC ID #)
Complies with the United States Radio communication requirements.
47 CFR Part 15
Radio frequency
transmitter
The symbol for non-ionizing radiation. All equipment and systems that
include RF transmitters or that intentionally apply RF electromagnetic
energy for diagnosis or treatment must be labeled with this symbol.
Radio Equipment Directive (2014/53/
EU)
Radio Standards
Specifications (CA).
Industry Canada Radio Communications License (IC:#)
Complies with Industry Canada Radio communication requirements.
(RSS-102)
Australian Radio
Communications
Requirements.
Australian Radio Communications License Complies with Australian
Radio communications requirements.
(AS/NZS 4417.1:2012)
Japan Radio Law Japan Radio Communications License Complies with Japan Radio Law
Notice 88.
(MIC Article 38-33)
Radio Frequency
Devices (U.S.)
This device complies with Part 15 of the FCC Rules. The 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.
47 CFR Part 15
13 Warranty and Compliance
Your Priya System is guaranteed to be free from material defects for a period (herein after referred to as Warranty Period) of one (1) year from the date of delivery
if you reside in the United States of America or Canada. If you reside in the European Union, Iceland, Norway, Liechtenstein or Switzerland and you purchased your
Product in the European Union, Iceland, Norway, Liechtenstein or Switzerland, the Warranty Period shall be two (2) years from the date of delivery.
If you reside in the United States of America, Canada, European Union, Iceland, Norway, Liechtenstein or Switzerland, and if at any time during the Warranty Period,
your Priya System does not work for any reason (other than as described in the Limitations below), it will be replaced with a new or a substantially equivalent
device or repaired, free of charge.
If you reside in the European Union, Iceland, Norway, Liechtenstein or Switzerland, you may ask for a price reduction or a refund in the following instances:
• if you are entitled to neither repair nor replacement; or
• if Prima-Temp has not completed the remedy within a reasonable time; or
• if Prima-Temp has not completed the remedy without significant inconvenience to you.
Damaged or defective units should be returned within TWO YEARS of delivery to the manufacturer at the address identified in the Warranty Policy, which can be
found at: www.priyafertility.com.
NOTE: Your Priya Sensor will only work for a maximum of 180 days from the date of first activation.
Limitations On Warranty
This warranty is subject to the following exceptions and limitations:
This warranty is applicable only to the original purchaser.
This warranty does not apply to units that malfunction or are damaged due to obvious abuse, misuse, alteration, neglect, unauthorized maintenance or failure to
operate the Priya System in accordance with instructions.
There is no other express warranty for this product. The option of replacement, repair, price reduction and refund described above, are the warrantor’s obligation
under this warranty.
Please see the complete list of Limitations in Warranty Policy at: www.priyafertility.com
For Warranty Service
FCC Interference Statement
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. The FCC ID is
2AE3ZPTPL1007. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Using this equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment o and on, you are encouraged to try to correct the interference by doing one of the following:
Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet that is on a dierent circuit from the receiver.
- Consult Prima-Temp or an experienced radio/TV technician for help.
FCC Caution
Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment.
FCC Radiation Exposure Statement
This equipment complies with FCC Radiation Exposure Limits for an uncontrolled environment.
This transmitter must not be co-located with or operating in conjunction with any other antenna or transmitter.
14 Customer Service
If you should have any questions not covered either here or in the question and answer section of our website, please contact us at www.priyafertility.com or at
priyasupport@kindara.com.
For more information about the Priya System, or if your Priya Sensor is broken, quits working, or you need further assistance, please contact us via email at
priyasupport@kindara.com.
Disclaimer
This product is not intended to diagnose, cure or prevent disease. Prima-Temp, Inc. makes no claims, representations or warranties regarding the ability of this
product to cure any physical or mental conditions. A qualified health professional should be consulted with regard to any condition requiring medical attention.
Part Numbers
PT PFS 1001 Priya Sensor
16300001 Instructions for Use
18300001 Priya App
For faulty or defective units, please email priyasupport@kindara.com for return authorization number and address.
Manufacturer
Prima-Temp, Inc.
3100 Arapahoe Ave, Suite 500
Boulder, Colorado 80303
United States
1-833-386-5222
www.Prima-Temp.com
Emergo Europe
Prinsessegracht 20 2514 AP The Hague
Netherlands
+31.70.245.8570
+31.70.346.7299
2797
