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Fertility Focus OvuSense - 1.0 Important Notes; 1.1 Indications For Use; 1.2 Device Components List; 1.3 Warnings and Precautions

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Page 1
OvuSense
User Manual
Important Notes
1.0 Important Notes
1.1 Indications For Use
The Fertility Focus OvuSense Fertility Monitor (which includes
OvuSense Reader M010-EN and OvuSense personal Sensor
M011) is intended for measuring and recording basal body
temperature (BBT) as an aid in ovulation prediction to aid in
conception (not to be used for contraception).
1.2 Device Components List
This user manual covers the following components:
OvuSense Reader M010-EN
OvuSense Sensor M011
1.3 Warnings and Precautions
THIS PRODUCT IS
NOT FOR CONTRACEPTIVE USE
As with the use of tampons, there may be a small risk of toxic
shock syndrome – a rare condition caused by the bacterium
Staphylococcus aureus growing on blood or fluids in the vagina.
If you feel ill or have a high temperature (above 39˚C or 102˚F),
muscular pains, headaches, vomiting, diarrhoea, or if a skin
rash appears, STOP using the Sensor immediately and see your
doctor.
DO NOT use the Sensor during your menstrual bleed. Should
spotting occur, or an unexpected bleed begin, STOP using
your Sensor until this bleeding stops. The Sensor will not
produce valid fertility monitoring results during menstruation.