Certification and research confirm Daysy’s safety and quality:

 

Daysy - a medical product to rely on

 

Daysy has been developed as a medical product and registered accordingly with the CE mark. Not every cycle or fertility monitor on the market meets these standards. Unlike Daysy, not all were developed as medical products and are controlled by a quality management system. You can feel confident that Daysy’s safety and quality are our highest priority.

 

Daysy’s claim: certification, safety and quality

 

Valley Electronics AG, based in Switzerland, has developed Daysy, a medical product that focuses on the woman’s cycle and enables a better understanding of the female body. Valley Electronics AG is certified with EN ISO 13485:2016, meaning that our quality management is oriented toward the newest standards for medical products. As the customer, you are at the center of all decisions in product development and manufacturing regarding safety and risk. All procedures at Valley Electronics AG are regularly subjected to internal and external controls. This allows us to continuously enhance the quality of the product throughout its entire life cycle.

 

Quality Management System Certificate EN ISO 13485_2016.pdf (447.6 KB)

 

 

 

 

Daysy`s Pearl-Index

 

The effectiveness of every contraceptive, as well as fertility trackers, is based on the Pearl-Index (PI). This is calculated by how many pregnancies occur in a group of 100 women in the course of one year. For example: if one out of 100 women who use the same method for one year becomes pregnant, the Pearl-Index is 1.0. If two women become pregnant in one year, it is 2.0. This means that the lower the Pearl-Index, the safer the contraceptive.

 

 

Daysy's method-related safety is calculated as a Pearl-Index of 0.6, so your fertility status as determined by Daysy has a 99.4% accuracy. In terms of user-related safety, Daysy has a Pearl-Index of 1.3, which means that Daysy and the App DaysyView prove to be particularly effective in everyday life and provide a highly reliable indication of when you are fertile and when you are not. At the same time, women with a desire to have children also learn when the chances of pregnancy are the best.

 

Daysy Clinical Trial 2018.pdf (937.4 KB)

 

Important: Daysy is not a “contraceptive app” or “birth control computer.” Due to their certification, popular “contraceptive” apps advertise to be in the same class of medical product as the condom. According to directive 93/42/EWG, medical products that serve as birth control or protection from sexually transmittable diseases, such as the IUD or condom, are automatically assigned to class IIb. However, this classification gives no indication of the efficacy of a method of birth control. The classification only indicates the risk to the user’s health in terms of possible side-effects such as infections, intolerance, adhesions, thrombosis or the possible transmission of HIV. Since an app alone cannot prevent pregnancy or STDs, being named a contraceptive and thus placed in Class IIb is very misleading. Daysy indicates fertile and infertile days with 99.4% accuracy and completely side-effect free.  It is the user’s choice to plan or prevent pregnancy on these days.

 

 

Clinical Research

 

Daysy is based on the same algorithm as the devices of its sister company, Valley Electronics GmbH, which have been evaluated and tested for more than 30 years. The method- and user-related safety of the algorithm has been previously tested in a clinical study resulting in a method-related Pearl-Index of 0.7 and a user-related Pearl-Index of 3.8 [Freundl et al., 1998].

 

The next clinical study followed in 2018 with the Women’s Clinic at the University Clinic Erlangen. The key question of the current study was whether the optional use of a mobile application (DaysyView App) as a display of the individual cycle could improve interest and thus the user-related safety. For the study, a total of 6278 Daysy users worldwide were contacted via email. The participants should answer questions about their individual cycle, experiences with contraceptives, pregnancy, the desire to have children and the use and acceptance of the app. A total of 4738 cycles were evaluated.

 

The results of the current study show that the method-related Pearl-Index has improved from 0.7 to 0.6, confirming the very high safety of Daysy and the integrated algorithm 20 years after the first study. If the user-related safety is examined, the Pearl-Index improves by more than half from 3.8 to 1.3.

 

The Pearl Index, also called the Pearl rate, is the most common technique used in clinical trials for reporting the effectiveness of a birth controlmethod. We used the Pearl Index in our study because this is the only available calculation to explain the effectiveness of a method even in fertility tracking. There is no other calculation out there so far for methods which are not per se a form of birth control. However, Daysy is not a contraceptive it shows you when you should use a contraceptive to not get pregnant. We believe that only a method like a condom, Diaphragm etc. are a form of contraception. Abstinence can be considered a form of contraception and that is why fertility awareness-based methods could be called a form of natural contraception.

 

Daysy shows the fertile and infertile window with an accuracy of 99.4%.

 

Daysy Clinical Trial 2018.pdf (937.4 KB)

 

Daysy Clinical Trial 2018 short version.pdf (81.7 KB)

 

 

 

Daysy’s claim: certification, safety and quality

 

Valley Electronics AG, based in Switzerland, has developed Daysy, a medical product that focuses on the woman’s cycle and enables a better understanding of the female body. Valley Electronics AG is certified with EN ISO 13485:2016, meaning that our quality management is oriented toward the newest standards for medical products. As the customer, you are at the center of all decisions in product development and manufacturing regarding safety and risk. All procedures at Valley Electronics AG are regularly subjected to internal and external controls. This allows us to continuously enhance the quality of the product throughout its entire life cycle.

 

Quality Management System Certificate EN ISO 13485_2016.pdf (447.6 KB)

 

 

 

 

Our Research:

 

  • Retrospective clinical trial of contraceptive effectiveness of the electronic fertility indicator LadyComp/BabyComp.  [Freundl 1998]

 

  • Result: User-Related Pearl-Index 3.8

 

  • Method safety: Method-Related Pearl-Index 0.7

 

  • Calculation of the Pearl-Index of Lady-Comp, Baby-Comp and Pearly cycle computers used as a contraceptive method [Binkiewicz 2010]

 

  • Result: The findings from 1998 were confirmed.

 

  • Evaluation of the effectiveness of selected natural fertility symptoms used for contraception: estimation of the Pearl-Index of Lady-Comp, Pearly and Daysy cycle computers based on 10 years of observation in the Polish market. [Demianczyk 2016]

 

  • Result: The findings from 1998 were confirmed.

 

  • Improving usability and pregnancy rates of a fertility monitor by an additional mobile application: results of a retrospective efficacy study of Daysy and DaysyView App [Koch 2018]

 

  • 800 women took part in this international study.

 

  • The study was conducted and reviewed by 13 clinical gynecologists from three different universities.

 

  • A total of 4738 cycles were evaluated

 

  • Result:

 

  • User-Related Pearl-Index 1.3

 

  • Method-Related Pearl-Index 0.6

 

 

A few degrees make the difference

 

In addition, Daysy uses a very sensitive sensor to measure the basal temperature. Its unique feature is that it waits for the mean temperature value, which can take between 30 and 60 seconds. The sensor warms up before it records your basal body temperature in order to receive a reliable result.

 

Daysy waits until the final temperature value has stabilized to complete the reading. If the temperature drops during the measurement (for example, due to cold air that gets into the mouth through breathing), the sensor waits for it to rise again and stabilize. This method ensures that the measurement is as precise as possible.

 

 

 

 

Daysy: we pursue safety, certification and quality all the way!

 

We want to offer even more than the current standard. That is why we continuously work to optimize Daysy. Needs and preferences can change during the daily use of Daysy, which is why we always strive to find the best solution for our users. To create and develop a world-class product, attention to detail is just as important as the big picture. In the future, we will continue to spare neither cost nor effort to make sure that you are always happy and safe with Daysy! Our mission is maximum safety and quality for you!

 

Quality Management System Certificate EN ISO 13485_2016.pdf (447.6 KB)

 

 

Customer Care Details

 

Tel:    011 462 4799