VivoSensMedical OvulaRing User manual

USER MANUAL

OvulaRing shows you when
your fertile days are, no
matter how your cycle ticks.






myovularing
www.myovularing.com
 Ring made of medical plastic
 Biosensor
 OvulaRing, comprising a medical
plastic ring with clicked-in biosensor
 Reading device with sensor holder and cap
 myovularing software can be reached at
www.myovularing.com
Product overview

Dear OvulaRing User,
Thank you for choosing OvulaRing.
Using a vaginal biosensor, OvulaRing records your core body tempe-
rature automatically, around the clock. Without the need for tiresome
morning temperature taking. Instead of one measurement, OvulaRing
records 288 measurements a day, thus enabling a much more precise
observation of your cycle, independent of cycle length and external
influences such as stress, sleep, sport or nutrition. Medical algorithms
evaluate the data and identify your individual cycle and fertility
pattern.
With OvulaRing you can discover if you are ovulating or if there is
an indication of a hormonal cycle disorder. In addition, you can view
your daily conception probability in real time and view a forecast for
ovulation in the subsequent cycle.
Please read the user manual carefully before unpacking and use! If
you have any questions, please contact our team of experts at any
time:
Telephon: +     
E-mail: [email protected]
We hope that you enjoy using this product.
Your OvulaRing team

Fertile days
Cycle days
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
°C
36,0
37,6
36,6
36,8
37,0
37,4
37,2
36,2
36,4
Follicle maturation Ovulation Luteal phase
Maturation phases of the egg cell and course of the core body
temperature

There are only  days per cycle on which sexual intercourse
can result in pregnancy. This fertile phase includes the 
days before ovulation, the day of ovulation itself and the day
after. The chances of pregnancy are greatest  days before
ovulation.
However, the timing point of ovulation is different for each
woman and may vary from cycle to cycle. Body tempera-
ture rises after ovulation with the simultaneous release of
the hormone progesterone, increasing by . - . °C. If the
temperature remains elevated for  days, you can be sure that
ovulation has occurred and that the fertile phase is complete.
The high resolution temperature measurement allows
OvulaRing to detect the smallest changes in temperature
even before ovulation and shows you your fertility window,
without the need for morning temperature taking.
A wealth of further information regarding the female
cycle can be found on our website www.ovularing.com.
OvulaRing shows you
how your cycle works

Cycle monitoring with OvulaRing
In the st usage cycle, OvulaRing gets to know your individual cycle
patterns. You will receive an evaluation for this first cycle when it has
been completed. Then you will find out whether ovulation has occur-
red and if so when. You will also receive other important information
about your cycle health. If ovulation has been detected, OvulaRing can
now use your individual cycle pattern as the basis for evaluating the
subsequent cycles. In the first cycle, we recommend that you remove
and read out the sensor for the first time after  days. You can find
detailed instructions on this under the section ‚Removing OvulaRing
from the vagina‘. If the data transfer worked without any problems,
you can put the ring back in and wear it until the beginning of the
period.
In the nd usage cycle you can use the display of the current concep-
tion probability. This requires that OvulaRing is inserted at the latest
on the 6th day of the cycle and recording gaps are smaller than  hour
per day. In addition, new data must be uploaded. We recommend
uploading data daily from approximately  to  days before the cycle
day on which your fertile phase began in the st cycle.
. Wearing
OvulaRing
. Evaluating
your cycle
. Uploading
data

The current conception probability is displayed with the following
status reports:
→Fertile phase has not yet begun
→Low – There is a low likelihood of conception.
→Medium – There is a medium likelihood of conception.
→High – The likelihood of conception is highest on this day.
→Unlikely, the fertile phase for this cycle has passed – Conception
is therefore unlikely.
If the status report “Unlikely, the fertile phase for this cycle has
passed” appears, you no longer need to read out OvulaRing daily
and can wear it without interruption until the beginning of the next
menstruation.
From the th usage cycle onwards you receive an ovulation forecast
for the following cycles. Prerequisite for this is that ovulation was
recognised in the first 3 cycles. If ovulation fluctuates by more than 8
days in the subsequent cycles, no safe forecast can be provided. Please
note that the forecast is an approximate value and is calculated on the
basis of the last completed cycles. The findings for the current concep-
tion probability may vary from this, as they are based on more recent
data. Therefore, we always recommend comparing the results of the
prognosis with those of the daily probability of conception.

Great emphasis should be placed
on hygiene during use. Please
wash your hands each time before
inserting or removing OvulaRing.
Biosensor and medical plastic
ring are supplied separate from
each other in a hygienic, clean
condition. Please only remove the
biosensor and plastic ring from
the packaging directly prior to
insertion.
Disinfect the biosensor and plastic
ring thoroughly with the enclosed
disinfectant wipes prior to each
insertion.
Place the biosensor in the plastic
ring and insert it into the vagina.
A
D
B
C
What do you need to pay attention to
before and during use of OvulaRing?
Hygiene and cleaning instructions

Note:
Following each removal of the biosensor from the body it is sufficient
to clean the sensor with mild, ph-neutral soap under running, luke-
warm water. Following this, rinse the biosensor well with clear water
and dry. Please also clean the sensor holder and the cap of the reading
device regularly in the same way.
Service life and storage of biosensor and
medical plastic ring
On the packaging of the biosensor and plastic ring you will find the
packing date and the maximum storage date, which states the date
until which the biosensor and plastic ring may be used.
Medical plastic ring: The plastic ring may remain in the vagina for
a maximum continuous period of 30 days at a time and must be
replaced at the latest after this time. Naturally, you may remove it for
reading and insert it again as often as you like.
Biosensor: The battery life of the biosensor is approximately 6
months. The battery status of your sensor is communicated with each
data upload. If the battery is running low, we will send you a replace-
ment sensor automatically. The booked application time starts on the
day on which the first temperature value is recorded with the sensor,
at the latest 4 weeks after the date of sending of your OvulaRing
package. The internal memory of the biosensor can record data for
up to 3 months. If the memory is full, no new temperature values can
be saved. Therefore, the biosensor should be read out at least every 4
weeks. When the biosensor is not located in the vagina, no tempera-
ture value is recorded. During this time store the biosensor in a dry,
light-protected location in the storage box supplied.

How to use OvulaRing
OvulaRing is inserted into the vagina following the end of menstruati-
on, or at the latest on the 6th day of the cycle. The first day of the cycle
is the first day of the period. Prior to inserting OvulaRing make sure
that the biosensor is correctly clicked into place in the plastic ring.
Inserting the biosensor into the plastic ring
Wash your hands, the plastic ring and the biosensor as described
under the hygiene and cleaning instructions. Take the clean biosen-
sor and press it into the hollow space of the plastic ring. Place the
biosensor into the plastic ring above a soft surface(e.g. a towel). This
can prevent damage to the sensor in the event of it falling down. The
biosensor should lock in securely via the groove in the plastic ring. The
biosensor should not slip out of the groove when the ring is twisted
and bent! Please check this carefully. If this occurs, the biosensor has
been inserted incorrectly and must be removed and inserted again.

Inserting OvulaRing into the vagina
Press OvulaRing together lightly with thumb and index finger. Now
insert the compressed ring with the sensor in front deep into the va-
gina. Raising one leg may aid this. Some women find it easier to insert
the ring whilst squatting or lying down. It is a good idea to try various
positions until you find the one you are most comfortable with.
After releasing, OvulaRing automatically resumes its original ring
form. Now use your middle or index finger to push OvulaRing to the
deepest point of the vagina. The ring slides into the correct position
and is no longer noticeable.

Removing OvulaRing from the vagina
To remove OvulaRing from the vagina grip it with the index or middle
finger and draw it out. Then remove the biosensor from the plastic
ring, clean it with a mild, ph-neutral soap and rinse it well under
running lukewarm water. If you now wish to place the biosensor into
thereading device or store it in the box during the time of menstruati-
on, dab it dry beforehand with a clean, soft cloth or place it on a clean
surface for a number of minutes until it is dry.
Data upload
With the aid of the OvulaRing reading device you can upload the data
of the biosensor simply and unassisted. In this process the device ge-
nerates and saves a file that is identified with sensor number, date and
time of reading (in Greenwich Mean Time). After successful read out,
the reading device can be accessed like an USB stick. You can upload
the current file to our secure web database via www.myovularing.
com.

Read out is performed as follows:
1. Clean the biosensor before reading, in accordance with the hygi-
ene and cleaning instructions. The sensor holder may be removed
from the reading device for cleaning purposes.
2. Plug the sensor into the reading device and ensure that it does not
fall out.
3. Connect the reading device with sensor to your computer via the
USB port.
4. The transfer of data now begins automatically. The data is trans-
ferred from the sensor to the reading device. This is indicated by a
rapid flashing of the LED and may take up to 30 seconds, depending
on file size.
5. Following successful reading the file is deposited on the USB me-
mory of the reading device and the sensor memory is deleted. The
reading device now switches to mass storage mode, indicated by a
slow, gentle flashing of the LED. If the LED is illuminated constantly
again after the reading process, no data has been transferred. In
this case repeat the read out of the sensor in a different position in
the reading device.
6. Log in to www.myovularing.com with your access data and select
the option ‘Upload data’ on the start screen. Further information
1.
2.

regarding the web software can be found in the sub-section ‘Using
the myovularing software‘.
7. Select the drive of the reading device in the upload dialogue
and select the current file in the DATA folder. The file name is
coded as follows: Sensor number_Date_Time of reading; e.g. 
__.ovu.
8. After successful uploading a message appears that your data
have been saved in the database. Now the results of the current
likelihood of conception are displayed to you or you can view your
cycle curve.
Note:
It is also possible to connect the reading device to the computer first in
order to read out the sensor. With this option, the time until the sensor
is plugged into the reading device may not exceed 30 seconds. If you
do not insert a sensor into the reading device within these 30 seconds
after connecting the reading device to the computer, it switches to
mass storage mode (USB stick). This is indicated by the slow, gentle
flashing of the status LED on the top of the reading device and your
computer recognises the reading device as a drive. This enables you
to see old files without reading the sensor, for example. If you wish
to read out the sensor again, eject the reading device (as with a USB
stick), remove it from the computer and connect it again with the
sensor inserted.
Using the myovularing software
Launch the software www.myovularing.com in your web browser.
Username and first password for the web software can be found on
the back of these instructions. Be sure to keep these in a safe place.
When you log into the software for the first time you will be asked
to change your password. This is a security measure to ensure that
only you know your password. When logging in for the first time you

can also add your e-mail address to reset your password, if you have
forgotten it. You cannot change your username, this should be noted
or memorised.
After successfully logging in to www.myovularing.com the start screen
appears, containing an overview of the most important software
information. Using the ‘Upload data’ button you can access the
OvulaRing reading device, select a file and update your data. For clear
allocation of the cycles please state the first day of the most recent
menstrual period (enter beginning of cycle). After uploading the
data you can view your cycle curve and use further functions of the
software.
Overview of the individual functions
st Cycle - learning cycle and retrospective analysis
Your first OvulaRing cycle is a learning cycle. Here the algorithms get
to know your individual cycle pattern in order to compare this with
the patterns in the following cycles. At the end of the cycle you learn if
you have ovulated, when your fertile phase was and if the second half
of the cycle was sufficiently long.
2nd cycle - daily conception probability
From OvulaRing cycle two it is possible to identify your daily fertility
status. This requires that you insert OvulaRing at the latest on the 6th
day of your cycle and avoid recording gaps of more than one hour. Fol-
lowing this, each time the data is uploaded your conception probabili-
ty will be stated as low, medium and high. The system also shows you
if your fertile phase is completed.
From cycle 4 - ovulation forecast
After three recorded OvulaRing cycles with ovulation the software is
generally able to give you a forecast for ovulation and fertile phase
in the following cycles. This requires an ovulation in each of the

first three cycles. If ovulation fluctuates by more than 8 days in the
subsequent cycles, no safe forecast can be provided. Please note that
the forecast is an approximate value and is calculated on the basis of
the last completed cycles. The findings for the current likelihood of
conception may vary from this, as they are based on more recent data.
Pregnancy test and calculation of due date
The OvulaRing software has an integrated, free pregnancy test. If a
pregnancy is identified, you can also precisely calculate a provisional
due date.
Further functions
You can also use the OvulaRing software as a cycle diary and enter
various additional markers such as sexual intercourse, sport, stress, ill-
ness or medication taken. in addition, you can also look at an overview
of all recorded cycles in the statistics.
A detailed explanation of the software can be found in the software
operating instructions, you can view and download these at
www.myovularing.com or www.ovularing.com.
For questions regarding use of the software and evaluation of your
data please go to www.myovularing.com or contact our team of
experts in confidence:
Telephone: +    
E-mail: [email protected]

General safety
information
→ OvulaRing has been produced and tested in accordance with the
applicable statutory requirements and thereby complies with all
possibilities open to the manufacturer to avoid health risks.
→ OvulaRing provides support in the diagnosis of female cycle health
and can be used to determine fertile phases, i.e. fertile days. Ovu-
laRing is not a replacement for individual contraception measures
and means (e.g. condoms). If you do not wish to become pregnant,
you must use a contraceptive method of your choice.
→ Infections, high stress, high levels of sporting activity or long-term
pressure as well as a lack of sleep, particularly where this occurs or
increases abruptly, influence the hormonal cycle and can inhibit
the evaluation of the software. In these cases please update your
data regularly, at least every 2 days, and take note of all evalua-
tions. In case of doubt, please contact our customer service.
→ The plastic ring may remain in the body for a total of 30 days at a
time. After this it should be disposed of in the household waste.
→ OvulaRing should be examined for any visible defects and changes
on removal from the body. OvulaRing may not continue to be used
after the use-by date.
→ If you experience pain following insertion of OvulaRing, please
remove it and consult your medical specialist.
→ OvulaRing can be swallowed. Please keep out of reach of children.
→ OvulaRing is not a thermometer and is not suitable for direct
temperature measurement (e.g. in the manner of a clinical ther-
mometer).

→ If you are taking medication over an extended period of time that
affect the body temperature (e.g. progesterone), this may affect
the results of OvulaRing.
→ Do not use any other aids for insertion and removal of the ring.
Information for
safe use
→ Do not use any aggressive disinfectant or cleaning agents, scouring
powder or hard brushes for cleaning. Do not use chemicals or hot
water.
→ Do not clean the plastic ring and biosensor in boiling water.
→ Do not store the biosensor in a disinfection cloth or in a disinfec-
tion solution.
→ Do not clean or disinfect the plastic ring and biosensor with the aid
of a microwave. Do not clean the plastic ring and biosensor in the
dishwasher.
→ If you are using vaginal therapeutics such as vaginal creams or
suppositories at the same time this may inhibit the material of the
plastic ring and the ring may break in rare cases. Please check the
plastic ring regularly where used in parallel with vaginal therapeu-
tics and change the plastic ring promptly in the event of defect or
breakage.
→ The biosensor should only be used together with the medical
plastic ring.
→ OvulaRing should not be inserted into more than one person. Mul-
tiple use is only permissible with one and the same person.

→ OvulaRing should not come into contact with pointed or sharp
objects.
→ OvulaRing should be protected against knocks and impacts.
Protect OvulaRing against high and low temperatures and avoid
direct sunlight.
→ Do not place OvulaRing on the radiator, in the oven or in the micro-
wave to dry. Do not place it in the freezer.
→ The ring may slip out of place during sexual intercourse or during
bowel movements. Please check the correct position regularly to
avoid loss of OvulaRing.
→ OvulaRing is designed for domestic use, please do not use it in
other medical environments, such as in emergency medicine.
→ Please only use the USB cable supplied.
→ Please use and store OvulaRing with a minimum distance of 30cm
to other electronic devices with radio-control functions, as these
may affect safe use of OvulaRing.
→ Please do not use the OvulaRing reading device in the vicinity of
water and splashing water.
→ Only IEC 60950-tested computers may be used as power source for
the reading device.
Send back to manufacturer in case of malefunctions.
Warning:
Technical alterations to the OvulaRing biosensor,
plastic ring or reading device are not permitted.