EarlySense Percept Contact-Free Fertility Sensor
Instructions for Use

Not for contraceptive use.
© 2017 EarlySense Ltd. all rights reserved. EarlySense, EarlySense Percept and EarlySense Percept logo are trademarks of EarlySense Ltd. All other trademarks are property of their respective owners.

Intended Use

The EarlySense® Percept™ system is a device intended for monitoring physiological parameters as an aid in ovulation window forecasting to aid in conception. EarlySense® Percept™ should not to be used for contraception purposes.

What is percept

EarlySense® Percept™ helps predict and track your ovulation. It listens to what your body is saying and the signals that it sends - and then delivers simple and valuable information about your monthly cycle to the Percept app, in real time.

As you try to conceive, EarlySense® Percept™ gives you the most valuable information at this important stage of your life — accurately predicting your
fertility window, thus increasing your chances of becoming pregnant. Percept will also let you know when to expect your period, inform you of your stress levels, sleep quality, average heart and breathing rates. Percept will be with you to help you plan and support you during this journey.

With mEarlySense® Percept™ there is no need for another gadget to deal with. Just slide the sensor under your mattress, set it and forget it. Go about your life with confidence – Percept is ready with the information you really need, when you really need it.

what's in the box
1
2
3
4
1
Contact-Free Fertility Tracker
2
AC Power Supply
3
Quick Setup Guide
4
Limited Warranty

* The sensor’s positioning guide is printed on the bottom of the sensor’s tray

Getting Started
1

Install the EarlySense® Percept™ app from the App Store (iPhone) or Google Play (Android).

Percept is optimized for smartphones with the following operating systems:

  • iOS 9.0 or later on iPhone 5S or later
  • Android 5.0 or later

A full list of supported models is available on our website at www.EarlySense.com

2

Launch the app and set up a new account.

Once registered, the app will ask a few questions to learn more about you. Answering these optional questions will improve Percept’s predictions of your monthly cycle.

3

Connect the app to the sensor.

When prompted by the app, connect your sensor to a power outlet. A green LED indication will light.

If it’s off, the app will ask for your phone’s
Bluetooth to be turned on.

The app will automatically connect to your
sensor within a few seconds and a blue LED will light on the sensor once setup
is complete and your sensor is ready for use.

Please be sure to keep your phone’s Bluetooth turned on when Percept is tracking you. Percept’s sensor relies on continuous Bluetooth connectivity with your phone during your sleep to properly track your body signals.

In case Bluetooth connectivity is lost between your phone and sensor during tracking, the data cannot be restored and Percept’s data quality will be reduced.

4

Place the sensor on your side of the bed under the mattress, just below your pillow line, approx. 6" (15cm) from the edge of the bed. Use the included positioning guide for optimal placing.

Ensure the power cord is not stretched too tight or is not trailing on the floor to avoid someone tripping over it.

The socket-outlet shall be installed near the equipment and shall be easily accessible.

Help Percept work better for you
1

Percept continuously learns your signals’ patterns through your sleep to further improve its accuracy in predicting your cycle events. Make sure the app is connected to the sensor every night so that your body signals are tracked.

Tip:
Percept is designed to automatically connect the app to the sensor without need to open the app. When going to sleep keep your phone close to bed, connected to the power and with Bluetooth on to ensure a seamless tracking experience.

2

Got your period? Make sure to mark it in the app. Percept will log this information and will produce more accurate results.

Daily Data Inputs

Percept learns your cycle and will automatically predict your fertility window or when your next period is.
Inputting when your period starts will further improve the accuracy of those predictions.

To input your period data press on ‘Today’s Data’ button on the main screen, press and hold the “Log Period” button then slide your finger onto your selected flow level.

If you are experiencing a fever sickness on a particular day, be sure to tap the “Fever” button. This will indicate Percept’s algorithms to consider this rise of temperature in your cycle calculations.

You may also log your sexual activity by tapping the “Sex” button. This will also reflect on the app’s calendar for easy overview of when you had sex in relation to your cycle.

Quick Troubleshooting
App calendar shows no predictions
  • Make sure to update the app with data from at least one cycle (last period date or when you get a new period).
Sensor appears as disconnected on screen
  • Use the app's on screen trouble-shooting steps.
  • Check that Bluetooth connectivity is enabled on your phone.
  • Check that the power is properly connected to the sensor unit and the green LED power indication light is on.
  • Check that the sensor's blue LED Bluetooth connection indication light is on.
  • Unplug the snsor from the power source, plug it back in.
  • In the app - go to app settings and relaunch the sensor connection wizard.
Day View screen shows "No Data"
  • Check that you have proper internet connection available on your smart-phone.

Your smartphone will need to be connected to the internet (using home WiFi or cellular connection) to allow proper tracking and analysis of your body's signals. If internet connectivity is lost during the night, Percept will continue to track you and store your data for up to 16 hours. Upon restoring connectivity, you will receive your complete data analysis.

Until connectivity is restored, the following may be affected:

  1. Future fertility window predictions
  2. Future period predictions
  3. Wellness summary data (total sleep time, sleep quality rating, relaxation levels, avg. heart and breathing rates)
  4. Data Quality may indicate lack of data

When going to sleep, check that the app is connected to the sensor and that you can see your vitals

The percept app fails to start
  • Check that you are using a compatible smartphone model as defined in this user guide or visit www.earlysense.com for a complete list.
  • Check that your smartphone's operating system (OS) version is supported as specified in this user guide.
Safety Instructions

Please carefully read all the instructions provided in this user guide before using the Percept Sensor:

  • This product should not be used to treat, cure, or prevent any medical condition.
  • This product is not intended to be used for contraception.
  • Any operation or handling of the sensor unit that is not in accordance with the instructions specified within nullify the product's warranty.
  • This guide, accessory directions for use and all precautionary information and specifications should be read before use.
  • Handle the sensor unit with care. Do not drop, knock or shake it.
  • The sensor unit is intended for indoor use only.
  • Do not use a damaged sensor unit. Use of damaged components may result in inaccurate readings.
  • Use and store the sensor unit in a clean dry place at 41-104° F / 5-40° C.
  • Use of the sensor unit close to any adjacent source of vibration may influence the accuracy of the system's measurements or create periodic interference with the measurements.
  • In case of a power failure, no data is collected by the sensor unit.
  • The Percept sensor units can only be used with the EarlySense® Percept™ app
  • A damaged sensor should not be disposed of as unsorted municipal waste. Contact your local distributor for unit disposal.
  • Contact EarlySense for assistance, if needed, in setting up, or using Percept; or to report unexpected operation, changes in performance, or events.
Explanations of system labels:

Caution / Warning

Consult accompanying documents

Water-Splash proof accessory

Sorted disposal

Manufactured by

Compliance with standards

System complies with IEC60601-1, IEC60601-1-11 and IEC60601-1-2.

For full information on EMC, refer to Appendix: Manufacturer Declaration regarding EMC

The sensor unit is continuously operated equipment and is water-splash proof (IP21).

Contraindications for use
  • Use of medications such as hormones and/or hormonal IUDs might affect performance accuracy
  • Irregular hormonal profile (e.g. PCO, less than 4 hours of night sleep) might affect performance accuracy
Warning and cautions

Never expose the product to direct sunlight for extended time periods.

There should not be any direct contact with the device. A mattress, mattress pad or mattress cover should always be placed as a barrier between the device and the user.

The device is intended for private, indoor use only and should only be used for the purpose for which it was designed and in the manner specified in the instructions for use. Improper use can be dangerous. The manufacturer is not liable for damage resulting from improper or careless use.

The sensor should not be used for persons who weigh more than 200 kg (440 Pounds). Usage of the System in such case might result in malfunction of the Sensing Unit.

The app collects health information. It is recommended to use available phone security measures (such as a password).

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.

ICES-003 Compliance: CAN ICES-3(B)/NMB-3(B)

Specifications
Product
Physical characteristics
Electric absolute maximum characteristics
operational characteristics
Power Consumption
Operating, Storage and transportation conditions
Contact Information

CustomerService@EarlySense.com

IsraelEarlySense Ltd. (Manufacturer)
7 Derech Ze'ev Jabotinsky. Ramat Gan 5252007, Israel
Phone: +972-3-752-2330  /  Fax: +972-3-752-2340

USA
135 Beaver Street. Waltham, MA 02452, USA
Phone: +1-781-373-3228  /  Fax: +1-781-373-2367

www.EarlySense.com
Appendix: Manufacturer’s Declaration regarding EMC

See the following tables for specific information regarding the System’s compliance to IEC 60601-1-2

Table 1: Electromagnetic Emissions

Percept is intended for use in the electromagnetic environment specified below. The user of the Percept System should assure that it is used in such an environment.

Table 2: System Compliance Information − Immunity
Table 3: Electromagnetic Immunity for systems that are not life supporting

Percept is intended for use in the electromagnetic environment specified below. The user of Percept should assure that it is used in such an environment.

At 80 MHz and 800 MHz, the higher frequency range applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a) 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 Percept System is used exceeds the applicable RF compliance level above, the Percept System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Percept System

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 6.0 V/m.

Table 4: Recommended separation distances between portable and mobile RF communications equipment and Percept (not life supporting)

Percept is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Percept as recommended below, according to the maximum output power of the communications equipment.

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 in watts (W) according to the transmitter manufacturer.

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

MK-1560 Rev.03