Description
CE medical device.
Persona is a contraceptive method without side effects and easy to use. It identifies the days of the menstrual cycle when there is a higher probability of becoming pregnant by monitoring changes in hormone levels in urine.
Using a simple urine test, it detects changes in the levels of two hormones (estrogen and luteinizing hormone) and indicates when it is possible to have sexual intercourse with a low risk of pregnancy (green days) and when there is a likelihood of becoming pregnant after unprotected intercourse (red days).
Persona consists of a touch-screen monitor and test sticks.

Directions for use
Do not use Persona if:
– your ovulation cycles are shorter than 23 days or longer than 35 (to check the duration of your cycle, count the number of days from the first day of menstruation to the last day before the next menstruation).
– you have had symptoms of menopause, such as night sweats or hot flashes.
– you are breastfeeding.
– you are undergoing hormonal therapies, such as hormonal contraceptives, fertility treatments, or hormone replacement therapy.
– you are taking other medications that could affect your cycle.
– you are taking antibiotics containing tetracyclines; once the therapy is stopped, you can start using Persona at the beginning of the next cycle.
– you suffer from liver or kidney failure.
– you have polycystic ovary syndrome.
– you cannot or do not want to become pregnant.

Persona is potentially suitable for:
– women in stable relationships.
– women who have experienced side effects from other contraceptive methods.
– women seeking a non-invasive solution.
– women for whom pregnancy would not be entirely unacceptable.

Persona cannot be used immediately if recently:
– you have breastfed.
– you have used contraceptives or hormonal medications.
– you have taken other medications that could affect your cycle.
– you have been pregnant (even if the pregnancy did not continue).
After pregnancy or when you have finished breastfeeding definitively or when you have stopped taking hormonal contraceptives or other medications that could affect your cycle, you must wait at least two consecutive natural menstrual cycles, lasting between 23 and 35 days.
After that, in the third cycle, you can start using Persona.

When to test
You need to test every time the test screen appears, always within the 6-hour interval you have chosen.
During the first cycle, the monitor will ask you to perform the test 16 times: the first time on day 6 of the cycle and the others from day 9 to day 23.
After the first cycle, the monitor will ask you to test 8 times during each menstrual cycle: the first time always on day 6 and then for 7 consecutive days that may vary from cycle to cycle.
If you forget to check your Persona monitor during the test interval, you may miss a test. Persona will make a decision using the available information; this may result in a greater number of “red” days for the current cycle and subsequent ones.

How to perform the test
Always use the first morning urine.
When you are ready, remove the stick from its packaging and use it immediately.
Place the absorbent tip, facing down, under the urine stream for three seconds.
Alternatively, you can collect a urine sample in a dry, clean container and place the absorbent tip in the urine for 15 seconds.
Keeping the test stick facing down, remove the cap from the handle and place it over the absorbent tip.
Wipe off any remaining urine from the test stick with a cloth.
Insert the test stick into the designated hole horizontally, and place the monitor on a flat surface.
Wait five minutes; after one minute the monitor will turn off, this is completely normal.
While the monitor analyzes the sample, a flashing light will be visible.
Never use test sticks from different batches in the same cycle.
Once the test is finished, an alarm will sound.
If the monitor is off, turn it back on.
The screen will prompt you to remove the test stick.
You can dispose of the stick with regular household waste.
As soon as you remove the test stick, the monitor will indicate whether you are on a “green” day or a “red” day.

Warnings
Persona does not protect against sexually transmitted diseases or the HIV virus.
Never reuse a test stick that has already been used.
At the end of the cycle, dispose of all remaining test sticks. During each cycle, you must use 8 test sticks from the same batch. The batch number is printed on the bottom of the box containing the sticks and on the protective wrapper of each individual test stick.
For in vitro diagnostic use.
This device is for home use.
Not for internal use.
Keep out of reach of children.
The monitor contains magnets.
Dispose of batteries according to appropriate recycling guidelines.
Using this tool in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets), can cause harmful electrostatic discharges resulting in errors in results.
This tool should not be used in close proximity to sources of strong electromagnetic radiation (e.g., mobile phones), as they may prevent it from functioning properly.

Format
The package contains one Persona monitor.
Test sticks are sold separately.

Cod. 81327572