Instructions for using the Shekan® App
1. Introduction
We are pleased that you are interested in using the Shekan® software. Please read this manual carefully before you start using Shekan®.
This manual is valid for Shekan® version 1.X.X (status of this manual: August 2023, edition 1.1).
If you are using a newer version of Shekan®, please refer to the current Shekan® user manual.
For further information and the current version of these instructions for use, please visit: https://www.kanvie.com/shekan.
1.1 Purpose 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 Risks
Non-regulatory use of the Shekan® app can lead to risks. Before using the sympto-thermal method of the Shekan® app, medical professionals should always be consulted for clarification.
Shekan® should not be used for contraception.
Using the sympto-thermal method for conception control could reduce the likelihood of becoming pregnant if unprotected intercourse is avoided on the fertile days identified by the method. However, we always advise you to use other contraceptives.
If pregnancy causes you health, financial or social complications, the use of the Shekan® sympto-thermal method is strongly discouraged.
Use of the Shekan® sympto-thermal method should be avoided if you are currently or have recently used any contraceptive medication.
1.3 Profile of the target group
Women with 23 chromosome pairs, both gonosomes having a value of X, between 18 and 45 years of age with a natural and regular menstrual cycle, who have a school-leaving qualification which reflects at least a level of education equivalent to the Fachhochschulreife of the Federal Republic of Germany.
Fluent knowledge of the language selected in the Shekan® App, both written and spoken, is required.
1.4 First steps with Shekan®
- If you have any questions, always contact us using the contact options at the end of these instructions.
- The sympto-thermal method with Shekan® should only be used after you have familiarised yourself with the information material in the "Discover" menu of the Shekan® App, as well as those on https://www.kanvie.com/shekan.
- The sympto-thermal method should not be used if you are currently taking (partially) contraceptive medication.
- For temperature measurements within the sympto-thermal method, you need a thermometer with a CE mark and a resolution of at least 0.05°C / 0.1°F or more accurate.
- Begin recording your period days to exit the calibration phase on future days.
2. The Shekan® software
2.1 Evaluations
The Shekan® app summarises its analyses for you in the main analysis circle at the top of the home menu.
The sympto-thermal graph shows you how Shekan® has proceeded with the automatic evaluation according to the sympto-thermal method, if this is currently used.
Attention: If you do not understand the evaluation of your cycle when using the sympto-thermal method or if you have the feeling that the evaluation might not be correct, you should always call up the overview of the cycle in question and follow the evaluation via the sympto-thermal graph. Reasons for uncertainty are almost always that the data entered cannot be evaluated according to the rules of the sympto-thermal method. You should take this as a hint to expand your knowledge about the sympto-thermal method and to study the information within the Shekan® app again carefully, or to consider the advice of medically trained professionals.
Shekan® is not a substitute for your own cycle analysis, but is designed to help you use the sympto-thermal method competently and efficiently. You must be able to check the plausibility of the Shekan® analysis yourself or under the supervision of medically trained personnel.
If the data you have recorded has been measured incorrectly by you, this can have serious consequences for the accuracy of the analyses of Shekan®.
2.2 Recording a period
In the Shekan® app, cycles are displayed as the time between the start of two different periods.
To record a new period, use the "Record period" button in your home menu of the Shekan® app.
Note that days that overlap with the period of a pregnancy entered in the Shekan® App cannot be marked as period days.
2.3 Record events
The menu for recording daily events allows you to save, edit or delete temperatures, cervical mucus textures, disturbances, symptoms and notes for the selected cycle day. Some events are required for the sympto-thermal method.
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
If these are missing, this can have a negative impact on the accuracy of the evaluation,
which is why new users of the Shekan® App in particular should record all obligatory events every day if possible, provided they are interested in the sympto-thermal method.
You can access the menu for recording the calendar menu or your home menu of the Shekan® App.
2.4 Cycle overview
This view contains a history of all cycles you have entered, with some important information per cycle (date of approximate ovulation (if determined), length of period).
Furthermore, you get statistics of your last (maximum) 12 cycles. These are calculated using averages of these cycles and do not include the current cycle.
2.5 Detailed view of a cycle
By selecting the arrow of an element of the cycle history, you will get more information about this cycle.
One of them is the sympto-thermal graph, in which you can see the measurement results of the sympto-thermal method.
Furthermore, the calculated times of the previous climaxes of the temperature test and cervical mucus test of the sympto-thermal method are displayed in this menu.
3. General Information & How to Contact Us
3.1 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.
3.2 Decommissioning at the user's request
To delete your Shekan® data, simply uninstall the Shekan app from your device.
3.3 Technical documentation
You can get an insight into the technology of the Shekan® app in the menu "Regulatory notices" in the settings of your Shekan app.
3.4 Quality management
At Kanvie, we attach great importance to the quality of our products. Therefore, you may be randomly asked to participate in an anonymous voluntary quality assurance survey within the Shekan® App. For more information on quality management, go to the "Regulatory notices" menu in the settings of your Shekan app or visit https://www.kanvie.com/shekan.
3.5 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
3.6 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