Instructions for Use of the Shekan® App

1. Introduction

We are pleased that you are interested in using the Shekan® software. Please read these instructions for use carefully before you start using Shekan®.

These instructions for use apply to Shekan® version 1.X.X (status: August 2023, edition 1.1).

If you are using a newer version of Shekan®, please refer to the current instructions for use.

For further information and the latest version of these instructions, please visit:https://www.kanvie.com/shekan

1.1 Purpose of the Shekan® App

You can find the intended purpose of Shekan® in the “Regulatory Notices” menu in the settings of your Shekan® app.

1.2 Risks

Improper use of the Shekan® app may lead to risks. Before using the sympto-thermal method provided by the Shekan® app, you should always consult medical professionals.

  • Shekan® should not be used for contraception.

  • Using the sympto-thermal method for fertility control may reduce the likelihood of pregnancy if unprotected intercourse is avoided on identified fertile days. However, we always recommend using additional contraceptive methods.

  • If pregnancy may lead to health, financial, or social complications, the use of the Shekan® sympto-thermal method is strongly discouraged.

  • The sympto-thermal method should not be used if you are currently using or have recently used contraceptive medication.

1.3 Target Group Profile

Women with 23 chromosome pairs, both gonosomes being X, aged between 18 and 45, with a natural and regular menstrual cycle, and with an educational level at least equivalent to the German Fachhochschulreife.

Fluency in the language selected in the Shekan® app, both written and spoken, is required.

1.4 First Steps with Shekan®

  • If you have any questions, please contact us using the options at the end of these instructions.

  • Only use the sympto-thermal method after familiarizing yourself with the materials in the “Discover” menu of the Shekan® app and on the website.

  • Do not use the sympto-thermal method if you are taking contraceptive medication.

  • Use a CE-marked thermometer with a resolution of at least 0.05°C / 0.1°F.

  • Start by recording your period days to complete the calibration phase.

2. The Shekan® Software

2.1 Evaluations

The Shekan® app summarizes analyses in the main analysis circle at the top of the home screen.

The sympto-thermal chart shows how the automatic evaluation has been performed.

If you do not understand the evaluation or believe it may be incorrect, review the cycle details and consult trained professionals if needed.

Shekan® does not replace your own cycle analysis. You must verify results yourself or with medical guidance.

Incorrect measurements may significantly affect accuracy.

2.2 Recording a Period

Cycles are defined as the time between the start of two periods.

Use the “Record period” button in the home menu.

Days overlapping with a recorded pregnancy cannot be marked as period days.

2.3 Recording Events

You can record temperatures, symptoms, and other data for each day.

Calendar method:

  • Menstruation days

Sympto-thermal method:

  • Menstruation days

  • Basal body temperature

  • Cervical mucus quality

  • Vaginal sensation

  • Disturbance factors

Missing data may reduce evaluation accuracy.

3. General Information & Contact

3.1 Supported Devices

Requires Android 6.0+ or iOS 12.0+.

3.2 Decommissioning

To delete your data, uninstall the app.

3.3 Technical Documentation

Available in the “Regulatory Notices” menu.

3.4 Quality Management

You may be invited to participate in anonymous surveys. More info is available in the app or online.

3.5 Contact

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

Email: app@kanvie.com

3.6 Manufacturer Information

Kanvie GbR
Speditionstrasse 15A
40221 Duesseldorf
Germany

Shekan® is a Class I medical device under Directive 93/42/EEC.

Basic UDI-DI: 426244707shekanET