Technical Documentation of the Shekan® App

1. Introduction

We are pleased that you are interested in the technical specifications of the Shekan® software.

This documentation applies to Shekan® version 1.X.X (as of June 2023, issue 1.1). If you have any questions, always contact us using the contact options at the end of this documentation.

For more information and the latest version of this documentation, please visit: https://www.kanvie.com/shekan

1.1 Intended use of the Shekan® App

You can find the intended use statement of the Shekan® app in the "Regulatory Notices" menu in the settings of your Shekan® app.

1.2 Purpose of this technical documentation

The calculations of many cycle software products are often treated with a high level of secrecy by manufacturers. Partly irrelevant information about your health is requested and results of the apps often have to be accepted by you without any explanation.

With this technical documentation, we want to give interested users an insight into the functionality behind the Shekan® app.

Advanced knowledge of the sympto-thermal method is recommended for optimal understanding of this documentation.

2. Basics of the Shekan® App

2.1 Cycle lengths

The length of a cycle is defined by the distance between the first day of a period and the last day before the start of the next period.

2.2 Calendar method

The calendar method is used by Shekan® as soon as at least the length of a whole cycle is stored in the app. As soon as it can be used, the user receives results on the expected length of the current cycle based on this method, unless their usage behaviour of the Shekan® app allows the use of the sympto-thermal method.

The calendar method is sometimes very unreliable and does not provide estimates of ovulation. Only by using the Shekan® app correctly and in accordance with the rules can the user activate the sympto-thermal method.

2.3 Mandatory and optional entries

The following entries are required by the system on a mandatory basis in order to use the respective method:

Calendar method:

  • Menstruation (period) days

Sympto-thermal method:

  • Menstruation (period) days

  • Basal body temperature

  • Cervical mucus quality

  • Vaginal feeling

  • Disruptive factors

Shekan® also offers the option of recording other events, such as personal notes or pregnancy test results, for each day, but these have no effect on the methods we offer.

3. Sympto-thermal method at a glance

3.1 Evaluation of the temperature

For the evaluation of the temperature test, at least 9 days of data are required. These must include the current and the two previous days. In parallel, the six days before are considered. From this data set, the highest temperature is determined and halved to the nearest tenth.

  • Main rule: Check whether there are three measurement results in a row that are all higher than those of the six previous days. The third measured value must be at least 2/10 C° above the highest of the previous six low temperatures.

  • Special rule 1: If the third measured temperature value is not at least 2/10 C° above the highest of the previous six lower temperatures, a 4th temperature value must be waited for.

  • Special rule 2: Between the 3 required higher measurements, one may fall below or on the auxiliary line. This value must not be taken into account.

  • Only one of the two special rules is used.

  • After discontinuation of hormonal contraceptive methods, an additional higher measurement after completion of the usual temperature evaluation is needed for the evaluation of the first temperature high, which must be higher than the 6 low values, but not necessarily 2/10 C° higher.

When the temperature test is completed, it is also completed on each subsequent day of the test completion within the cycle.

3.2 Evaluation of cervical mucus & vaginal feeling

The first thing to determine is which cervical mucus quality is the highest during the cycle.

The grades quality assessment are, in descending order of quality: A → B → C → D → Ø → ? where "?" indicates a gap within the documentation.

Here you will find a breakdown of the cervical mucus qualities and when they are used by the Shekan® app:

• Cervical mucus texture

• Vaginal feeling

The peak of the cervical mucus evaluation can only be determined retrospectively. Let us now look at the evaluation rules:

  • Rule 1: If cervical mucus of the same quality category as at the peak returns after the 3-day waiting period, the cervical mucus test evaluation must be restarted (reset the waiting period to 0).

  • Rule 2: If cervical mucus of the same quality category as at the peak reappears after the evaluation of the cervical mucus test has been completed but before the evaluation of the temperature test has been completed, the evaluation of the cervical mucus test must be started again (i.e. the waiting time is reset to 0).

If the cervical mucus examination is completed on one day of the cycle, it will be indicated as completed for each subsequent day of examination completion within the cycle.

3.3 Disruptive Factor Evaluation

A day is excluded from scoring by the disruptive factors check if:

  • You forgot to document the presence of disruptive factors.

  • You have entered a disruptive factor instead of "No disruptive factors".

If a confounding factor occurs for a date, then that day cannot be used to calculate ovulation.

3.4 After a pregnancy

The behaviour of the Shekan® app after a registered pregnancy depends on the length of that pregnancy.

For a length between 0-63 days: The monitoring of the cycles in the Shekan® app takes place as usual after the pregnancy has ended.

For a length of 64 days or more: The sympto-thermal method for predicting the cycle is not used, as your body first has to settle down hormonally again.

Breastfeeding can only be terminated within the Shekan® app by entering the first menstrual bleeding after the end of the pregnancy. Once your body has adjusted and the next cycle begins, the sympto-thermal method is used as usual.

The duration of the breastfeeding phase depends on how long and how often you breastfeed, or whether you breastfeed at all. This is an important aspect that affects the accuracy of future cycle predictions.

4. Assessments of the methods used

4.1 Assessments of the calendar method

The calendar method provides functions for the following estimations:

  • Start of the next period based on past lengths of your cycles.

4.2 Assessments of the sympto-thermal method

The sympto-thermal method provides functions for the following estimations:

  • Start of the next period based on past lengths of your luteal phases.

  • Approximate time of ovulation.

  • Approximate time period in which sperm have a relevant chance of survival until the approximate time of ovulation.

  • Approximate period of the luteal phase.

5. Data & Privacy

5.1 Management of user data

Use of Shekan® does not require an internet connection, except for completing financial transactions within the app. All data collected from the user is stored exclusively on the user's terminal device. An exception to this handling of user data exists within our quality management programme, which is explained later in this documentation.

For the traceability of purchases, a unique identification number is created for the Apple App Store or Google Play Store account of the user. This identification number does not provide any information about the person of the user and is only used for functionally necessary purposes.

5.2 Recovery of user data

Data collected from the user is irrevocably deleted when the Shekan® app is uninstalled.

Anonymised data on financial transactions may continue to be stored on our servers to enable, among other things, the recovery of purchases.

6. General Information & How to Contact Us

6.1 Devices and Platforms Supported by Shekan®

Use of the Shekan® app requires a modern smartphone running the Android 6.0 (or higher) or iOS 12.0 (or higher) operating system.

6.2 Quality management

Cycle data from real users helps us to ensure the optimal functioning of internal quality assurance processes.

This process looks something like this:

  1. If a user uses the Shekan® app for an extended period of time, they qualify to participate in the quality management programme under certain circumstances.

  2. Users with this qualification may be asked to participate in quality management every day.

  3. Participation is voluntary.

  4. A request to participate is made by random generator locally on the user's terminal device while using the Shekan® app.

  5. If the user agrees to participate, all data stored in the Shekan® app regarding the cycle, pregnancy lengths and, if stored, the user's date of birth will be transmitted to us.

  6. The above data is encrypted locally and transmitted to us anonymously, after which it is decrypted again.

  7. The request to participate in this programme may occur more than once.

  8. The research data collected through this programme does not provide a realistic means of identifying the individual user, however we do not wish to exclude this possibility. We strive to create the most transparent exchange possible to improve our products and any participation helps us make those same improvements.

6.3 Contact options

Our support team will be happy to help you with any questions or suggestions you may have.

Customer service: https://www.kanvie.com/contact

Email: app@kanvie.com

6.4 Information about the manufacturer, CE conformity

Shekan® is produced by:

Kanvie GbR
Speditionsstrasse 15A
40221 Duesseldorf
Germany

Shekan® is a class I medical device according to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

Basic UDI-DI of the Shekan® app: 426244707shekanET