SAMSUNG Health Monitor Application User Manual

SAMSUNG Health Monitor Application

Specifications

• Product Name: Natural Cycles – Cycle Tracking
• Application Type: Mobile software application
• Intended Use: Period and cycle tracking
• Target Population: Women of reproductive age

FAQ

Frequently Asked Questions

• Q: Can men use the Cycle Tracking feature?
  • A: The Cycle Tracking feature is specifically designed for women of reproductive age.
• Q: Is the app a contraceptive method?
  • A: The Cycle Tracking feature is intended for period and cycle tracking purposes and should not be solely relied upon as a contraceptive method.

Please read this manual before you start using the Cycle Tracking.

Indications for Use

The Cycle Tracking in Samsung Health is an over-the-counter (OTC) software- only, mobile software application intended to be used for period and cycle tracking.

Intended Target Population

• The intended target group is women of reproductive age. The pediatric population <18 years of age is excluded from the target group.
• The user shall be capable of reading the IFU document and operating the Samsung Health application.

Intended Use Environment

• The device is intended for use in non-medical settings.

Contraindications

• The Cycle Tracking is not intended to be used for contraception.

Side-Effects

• The product has no known direct side effects on the human body.

Warnings

• Do not use fertility information given in the app as a form of birth control.
• Do not use data from the Cycle Tracking to diagnose health conditions, including using the skin temperature data to diagnose fever.
• The user is not intended to interpret or take clinical action based on the app output without consultation of a qualified healthcare professional.

Precautions

• If you are currently taking hormonal birth control or undergoing hormonal treatment that inhibits ovulation, this product will not be useful for tracking ovulation.

Checklist

To get started with the Cycle Tracking, you will need the following:

1. An Android smartphone (Android O (8.0) or later) with the latest Samsung Health app
   • You can access Cycle Tracking via Samsung Health app on Android smartphone. The Samsung Health app can be downloaded through the Google Play Store or Samsung Galaxy Store. To use Samsung Health, a Samsung account is required.
2. Samsung Galaxy Watch5 and above or Galaxy Ring (optional)
   • Using skin temperature measurement supported by the Galaxy Watch5 and above or the Galaxy Ring, you can use the “Predict period with skin temp” function.

Platform description

Devices that may be used to access Cycle Tracking via the Samsung Health Application:

• Android Smartphones: Android OS version 8.0 and above, with an Internet speed of 250 kbps or faster
• Samsung Galaxy Watch 5 and above: Wear OS 4.0 and above
• Samsung Galaxy Ring: Zephyr RTOS 2.4.2 and above

How to use Cycle Tracking

Onboarding

1. Select Samsung Health app.
2. Select Cycle Tracking from the home tab.
3. Enter necessary data (last period date, last period duration, average cycle length).

Check your cycle status

1. You can check your cycle status and predictions on both a smartphone and Watch.
2. You can manually enter cycle-related information via both a smartphone and Watch.
3. You can delete your cycle-related data via a smartphone only.

Skin temperature measurement

1. Make sure that your Watch or Ring is connected to your smartphone.
2. Turn on the skin temperature function within the Cycle Tracking.
   • If your smartphone is connected to both your Watch and Ring, select the device you want to use to measure skin temperature.
3. Wear the Watch or Ring overnight.
   • Suggested wearing guide:
   • 4 hours during sleep
   • 5 times per week

Excluding a skin temperature

1. Excluding temperatures is optional
2. You can choose to exclude a temperature if you:
   • Feel hungover
   • Feel sick
3. You can exclude a temperature on both a smartphone and Watch
4. You can restore an excluded temperature on both a smartphone and Watch

Recording a daily log

You can record your symptoms and your mood during your menstrual cycle.

• Flow level, Symptoms, Moods, Ovulation test, Etc.

Safety And Performance

The ability to detect ovulation and predict the upcoming period with the Samsung Galaxy Watch was evaluated in a clinical study involving 56 subjects recording 98 cycles. Study subjects were instructed to wear the Samsung Watch during the night, measure their temperature orally with a thermometer in the morning and take urine-based ovulation (LH) tests prior to the predicted ovulation day. The ovulation day determined by the Watch data was compared with that by the LH test. It showed that the mean absolute difference was within 3 days. The mean absolute difference between the period start predictions and the actual period start was found to be less than 3 days.

The ability to detect ovulation and predict the upcoming periods with the Samsung Galaxy Ring was evaluated in a clinical study involving 53 subjects recording 209 cycles. Study subjects were instructed to wear the Samsung Ring during the night, measure their temperature orally with a thermometer in the morning and take urine-based ovulation (LH) tests prior to the predicted ovulation day. The ovulation day determined by the Ring data was compared with that by the LH test. It showed that the mean absolute difference was within 2 days. The mean absolute difference between the period start predictions and the actual period start was found to be less than 2 days.

Problems/Troubleshooting

If you experience difficulties in operating Cycle Tracking, refer to the troubleshooting guide below.

• Problem: You are unable to find the “Predict period with skin temp: function within Cycle Tracking.
  • Solution: Check that your wearable device supports measuring skin temperature during sleep. If your wearable device supports measuring skin temperature, make sure it is upgraded to the latest Maintenance Release using the Galaxy Wearable application. Also, make sure the Samsung Health app is the latest version.
• Problem: You are wearing a Watch or Ring at night but you cannot see the measured skin temperature data in the app.
  • Solution: If the quality of the measured skin temperature data is too low, or there are less than 4 hours of data available, the data will be discarded and will not be visible in the app. Make sure your Watch or Ring is worn correctly while you sleep. Also, make sure the battery on the wearable device is charged before you sleep, and keep your Watch or Ring on for at least 4 hours.
• Problem: You are wearing your Watch or Ring according to the instructions, but your ovulation was not confirmed.
  • Solution: Ovulation is detected based on your skin temperature during sleep. If your skin temperatures fluctuate significantly along the cycle, it becomes more difficult to detect ovulation. Make sure you wear your Watch or Ring correctly and measure according to our guidelines. Temperatures can also be affected by factors such as illness, traveling, medications, and disruptions to your daily routine.
• Problem: Your predicted and confirmed ovulation dates don’t match.
  • Solution: The prediction for your upcoming ovulation day is based on your historical data, such as when your ovulation usually occurs and how much this varies from cycle to cycle. Since every cycle is unique, you may ovulate on a day that is different from the predicted one. Once ovulation has actually occurred, your most likely ovulation day will be determined based on your temperature data. For other problems and questions, please contact the Samsung Customer Support team and our trained support agents will assist you.

Accessing the Instructions for Use

• The Instructions for Use can be found within the Cycle Tracking under the ‘About cycle tracking’ page or online on the Natural Cycles website.
• If you would like a paper copy of the Instructions for Use we will send you one at no cost. Contact customer support with your request.

Security

It is strongly recommended that you choose a strong password for your phone to protect your account from unauthorized use. While not recommended, if you choose to share your login with somebody, you do so at your own risk. Keep in mind that you can always revoke access by changing the password to your account.

If you would like to delete your account, please contact Samsung customer support at https://help.content.samsung.com/.
Please refer to the Samsung Privacy policy for further information on security and data privacy.

General Information

Explanation of symbols

• Manufacturer
• CE Mark
• Caution
• User Manual/Instructions for Use
• Medical Device

EC Declaration of Conformity

• Name of the Manufacturer: NaturalCycles Nordic AB
• Address of the Manufacturer: St Eriksgatan 63b 112 34 Stockholm Sweden
• Customer support: https://help.content.samsung.com/
• Device Name: Cycle Tracking

We declare that this product meets all applicable requirements of the Regulation (EU) 2017/745 for medical devices (MDR) and bears the mark CE.

Date of publication: 2024-05
Document version: V1.3

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