OvuSense User Manual
Contents
1. 4 3 Compare cycles The Reader enables you to review your previous cycles If you select this menu option the screen will show you a graph of the information from your last three recorded cycles Upper Graph Your last full cycle recorded w Middle Graph The graph for two cycles agov Lower Graph The graph for three cycles agov Press Confirm to Exit to Main menu Your Information OvuSense User Manual Page 17 4 4 Trying For A Baby Every cycle hormonal changes in a woman s body cause an egg to be released from the ovaries This egg travels into the fallopian tubes which connect the ovaries to the uterus This is called ovulation An egg lives for about 12 24 hours after it s released For you to get pregnant a sperm must fertilize the egg within this time Sperm can live for up to 5 days Research has shown that you re most likely to get pregnant if you have sex within your fertile window which lasts from about 5 days before you ovulate until 1 2 days after If you are trying for a baby you should be aiming to have sexual intercourse every 2 3 days throughout the cycle because that improves the quantity and quality of sperm However knowing your fertile window is key to maximizing your chances and this is where OvuSense helps Days of the fertile window Probability of conception on each day As this chart shows your chances of conception are at the very highest a2. The Sensor Personal Sensor fins must be neatly aligned in cradle Personal Sensor over cradle on Reader a Sensor tail T e Start Sensor Record 2 1 Switching the Reader On and Off Switch ON Press any key and hold it down for 3 seconds The screen will light up with the OvuSense logo and then display the Main menu Switch OFF Press the Confirm key and hold down for 3 seconds and release If no key is pressed for 3 minutes the Reader will automatically turn itself off 2 2 Cleaning the Sensor Before and after use the Sensor should be thoroughly cleaned by washing it with soap in hand hot water Make sure that you wash all parts of the Sensor including all of the tail and the area where the tail joins the main part of the Sensor Page 6 OvuSense User Manual You will need to clean your Sensor twice each day 1st time before you insert it for overnight use 2nd time after you have used it overnight so that it is clean when you place it on the Reader When you are not using the Sensor clean it and store it in its cradle on the Reader with the lid closed this will keep it clean and secure 2 3 Inserting Your Sensor The Sensor is shaped like a tampon and made of a special medical grade material This material is naturally slippery but if you find that the Sensor is dry to insert apply a very small amount of standard water based lubricant gel approved
3. You can now leave your Sensor in the cradle on the Reader until you use it again Begin each night with the At Night step outlined on the previous page Page 12 OvuSense User Manual 4 0 Your Information The Your Information screen can be used to monitor your current and previous cycles 4 1 Current Cycle The Your Information screen allows you to review ET the information collected in your current cycle The New cycle Ye alth display will update at each point when sufficient data has been collected but not necessarily each day Using the up and down arrows and the Confirm key you can navigate up and down between Previous cycle and Compare cycles As your cycle progresses OvuSense will inform you about your current fertility status OvuSense starts a monitoring temperature immediately In the first days of your first cycle of use the OvuSense Reader will tell you ovulation is not yet detected Your Information User Manual As you move towards your ovulation window it will start to predict the onset of ovulation The ovulation window is the four days immediately around ovulation from one day before until two days after ovulation OvuSense displays the ovulation window with a light green shaded area and the predicted date of ovulation with a blue vertical line OvuSense uses a number of methods to predict ovulation Sometimes it will predict ovulation
4. The day after you stop bleeding completely If you are still spotting after a period or if spotting starts during your cycle then you should not use the Sensor What if the Sensor falls out The Sensor is designed to be removed and reinserted for instance if you want to go to the toilet in the night and so if it falls out simply wash it and reinsert it as described in Sections 2 2 to 2 3 If you find that the Sensor is falling out on a regular basis then you should contact Service as outlined in the User Assistance Section on the back page of this manual What if want to have sex It is essential to remove the Sensor before sex We recommend that the Sensor is reinserted after sex to increase the amount of data collected If you decide to continue using the Sensor after sex remember to wash it before inserting it If you OvuSense User Manual Page 29 reinsert it in the same night and you have already activated the Sensor using the StartT button on your Reader you don t have to activate it again The Sensor will simply start taking readings from the time at which you reinsert The Sensor is designed to cope with changes in temperature so you won t get any false measurements Should I replace the Sensor after sex Yes in fact we recommend that the Sensor in reinserted after sex but you don t have to see the answer to missing a night Follow the instructions in the question above Can I use the Sensor during my perio
5. and Sensor are capable of withstanding an environment of 20 C to 50 C 4 0 F to 120 0 F in a relative non condensing humidity of 15 to 95 Reader and 15 to 100 Sensor Storage for a period of one month outside of these limits may lead to product failure and will invalidate the product warranty Operating Environment The OvuSense Reader must be operated in an environment of 16 C to 40 C 60 8 F to 104 0 F and in a relative non condensing humidity of 15 to 95 The OvuSense Sensor can be operated in an extreme environment of 20 C to 50 C 4 0 F to 120 0 F in a relative non condensing humidity of 15 to 100 but will discard temperature values recorded below 36 0 C 95 9 F and ignore temperatures above 42 0 C 107 6 F Disposal and Recycling Each Sensor has a life of one year After you have used your Sensor for 330 days a message will let you know that a new Sensor will be required for the next cycle For advice on recycling check with your local recycling services Page 36 OvuSense User Manual The OvuSense Reader is intended for use by a single user atatime It can be used by the same user with consecutive Sensors each of which has a lifetime of 1 year until their monitoring is finished For further information on recycling contact Service see User Assistance Section on back page of this manual Trade Marks OvuSense and the Fertility Focus logo are trade marks of Fertility Focus
6. been confirmed the date will be shown in full with the day of the week The date is now set and you can Accept or Cancel to return to the Set Up menu To set the Time Using the up and down keys on the Main menu highlight the Set Up option then press Confirm Select the Set Time option The current time will be displayed with the Clock field highlighted as illustrated below Using the upa and down keys select whether you want to use the 24 hour or 12 hour clock For example 23 00 or 11 00pm then j eI press Confirm a The Hours field is then highlighted Using the upa and down keys set the current Hour then press Confirm Once the Hours have been set the Minutes field is highlighted Using the up and down keys set the current Minutes then press Confirm The time is now set and you can Accept or Cancel to return to the Set Up menu Page 22 OvuSense User Manual Once you have finished setting up Date and or Time use the down key onthe Set Up menu to highlight the Exit option then press Confirm lt You will then return to the Main menu Note OvuSense will not automatically make changes for daylight saving or time zones and may be affected by irregular sleeping patterns You can change the time 1 hour using the instructions above to allow for daylight saving time without affecting your fertility information However greater time changes may cause errors
7. in the determination of your fertile window as may sleep pattern changes OvuSense works most effectively if you have a regular sleeping pattern OvuSense User Manual Page 23 5 3 Battery Indicator and Charging The OvuSense Reader permanently indicates the current status of the battery It does this using a small battery indicator similar to those used on mobile phones in the top right of the screen Some examples are shown Battery Full here When the battery is too low you will be told to plug in Battery 65 Full ae the charger Battery Charging Battery Low Step 1 Plug the charger into the back of your OvuSense Reader D Step 2 Plug the charger unit into a wall socket and switch the socket on Step 3 If the Reader is on the battery charging indicator p will show the unit is charging You should fully charge your unit by leaving it plugged in overnight Page 24 OvuSense User Manual 6 0 Messages 6 1 Fertility information Messages When you indicate on the Reader that a New Cycle has begun OvuSense produces detailed information on the length of your cycle and ovulation This will help you and if necessary your doctor to better understand your fertility and the best course of action to help you get pregnant Normally the message will be in the form Your last cycle length was i XX days You ovulated on day YY of your last cycle You may
8. it is not a problem if you occasionally forget to do so Simply remove it when you remember place it on the cradle of the Reader and download the data OvuSense is designed to cope with data downloading at any point in time I have inserted my Sensor but now am unable to locate it and remove it Don t panic this issue can occur occasionally and is normally easy to solve Follow the instructions in Section 2 4 work night shifts is OvuSense right for me In general normal night time sleep is the time at which your temperature is at its most stable However if you have a regular sleep pattern where you go to sleep at around the same time and wake up the same time in a 24 hour period on a continuous basis and you regularly have more than 4 hours sleep then OvuSense can still work for you even if you work nights If you have an irregular sleep pattern where your work and therefore sleep times change regularly or if you tend not to get more than 4 hours sleep then the results OvuSense provides are likely to be affected Page 34 OvuSense User Manual Should I only have sex around the time OvuSense has told me I am ovulating The OvuSense Reader provides a prediction of the start of the fertile window five days before the predicted date of ovulation You should have sex as often as possible during this time with a particular emphasis on having sex prior to the predicted date of ovulation because this is when you are at yo
9. 010 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 Important Notes Page 2 OvuSense User Manual The Sensor is for your personal use DO NOT share it with other women as this may present a risk of infection and invalidate your personal results DO NOT insert the Sensor anywhere other than your vagina DO NOT leave the device in place in the vagina during sex as this may present a risk to you and your partner If you experience repeated difficulty or discomfort during insertion or discomfort irritation or a vaginal discharge during use of the Sensor DO NOT continue use Consult your doctor Use of any hormonal contraceptive or intrauterine device at the same time as OvuSense may invalidate the data collected Electrical Safety amp Compliance The
10. Limited Warwick UK K Y Jelly is a registered trade mark of Johnson amp Johnson New Brunswick NJ USA Durex Play Feel and Sensilube are registered trade marks of LRC Products Limited London UK Clinical References 1 Fertility Focus Limited Internal Data Unpublished Papaioannou S Aslam M 2012 Ovulation Assessment By Vaginal Temperature Analysis Ovusense Fertility Monitoring System In Comparison To Oral Temperature Recording American Society for Reproductive Medicine 68th Annual conference Papaioannou S Aslam M 2013 Quality Index assessment of vaginal temperature based Fertility Prediction and comparison with LH Testing Ultrasound Folliculometry and other home Cycle Monitors American Society for Reproductive Medicine 69th Annual conference OvuSense User Manual Page 37 2 Papaioannou S Aslam M 2013 User s acceptability of Ovusense a novel vaginal temperature sensor for prediction of the fertile period J Obstet Gynaecol 33 705 709 3 Adapted from Colombo B Masarotto G 2000 Daily Fecundability First Results from a New Data Base Demogr Res 3 article 5 4 Lenton EA Landgren BM 1984 Normal variation in the length of the luteal phase of the menstrual cycle identification of the short luteal phase Br J Obstet Gynaecol 91 685 689 5 Lenton EA Landgren BM 1984 Normal variation in the length of the follicular phase of the menstrual cycle effect of chronological age Br J O
11. OvuSense Realtime Fertility Monitor User Manual s fertility focus OvuSense_ User Manual Thank you for choosing OvuSense OvuSense provides a full picture of your own personal ovulation and fertility with more certainty and less effort than any other method OvuSense predicts the onset of ovulation detects exact ovulation date all in real time from your first cycle onwards After your first cycle OvuSense will then use the detection of ovulation date to predict the fertile window the best time to attempt conception each cycle OvuSense will continue to predict onset detect ovulation date and predict the fertile window for each following cycle It will also tell you if ovulation is not detected This key information gives you the best possible chance of successful conception OvuSense has been rigorously developed and tested in extensive clinical trials against gold standard ultrasound follicle measurement It is 99 accurate comfortable and easy to use2 We wish you all the best in your fertility journey The team at Fertility Focus s fertility focus www ovusense com Contents 1 0 Important Notes 1 1 Indications For Use 1 2 Device Components List 5S NNN 1 3 Warnings and Precautions 3 0 Daily Use 9 3 1 Each New Cycle 9 3 2 At Night 10 3 3 In The M
12. ader and press the StartT key to activate it Recordings from the previous Sensor will remain in the memory of the Reader Care must be taken not to drop the OvuSense Reader or immerse it in liquids If this does happen you should check the unit is still working Disconnect from the mains supply Then switch it on If the Reader doesn t start or a warning message is displayed contact Service using the address in the User Assistance Section on the back page of this manual DO NOT clean the Sensor in disinfectants or alcohol or with antibacterial or disinfectant wipes DO NOT subject your Sensor to temperatures above 50 C or 122 F e g by boiling or microwaving as this will damage it Important Notes Page 4 OvuSense User Manual 2 0 Overview OvuSense has two parts a personal Sensor shaped like a small tampon and a Reader When you first unpack the Reader it will need to be charged overnight When using your OvuSense Reader for the first time you will be automatically prompted to set up the date and time as indicated in Section 5 2 The Reader Personal Sensor Cover Select Up Confirm Download LCD Display Select Down Operating Keys Confirm key referred to in this 7 manual with the symbol Up key referred to in this manual with the symbol New Cycle Your Health y Your Information Down key referred to in this manual with the symbol vY OvuSense User Manual Page 5
13. also get one of the following alerts i Ovulation was not detected confirmed in the last cycle OvuSense did not find evidence of ovulation in your previous cycle even though it may have provided a prediction You should not worry if you see this message once but if you receive it in two out of any three consecutive cycles you should seek the advice of a doctor Your last cycle length was XX days this is unusually short The data collected indicates that you have had an unusually short cycle less than 20 days ask your doctor s advice if this occurs regularly OvuSense User Manual Page 25 Your last cycle length was XX days this is unusually long The data collected indicates that you have had an unusually long menstrual cycle more than 37 days ask your doctor s advice if this occurs regularly Information and Alerts 6 2 System Messages You may occasionally receive a system message on your OvuSense Reader gt NOTE If the message appears for a second time after taking the suggested action note down the error number in the top left corner of the screen if there is one Press Confirm key to Exit Then contact OvuSense support as outlined in the User Assistance Section on the back page of this manual quoting the message and error number A fault has been detected with this device Please consult the user manual There is an problem with your Reader See gt NOTE Page 26 OvuSense User M
14. anual A problem has been encountered with this sensor Please consult the user manual Try placing the Sensor again in the cradle on the Reader ensuring that the fins on the Sensor are properly aligned Alternatively try turning the Sensor over in the cradle again ensuring that the fins on the Sensor are properly aligned See gt NOTE Sensor not detected Please ensure the sensor is located correctly on the reader and try again The personal Sensor may not be placed correctly in the cradle on the Reader Try placing it again ensuring that the fins on the Sensor are properly aligned in the Reader cradle Then repeat the Start or Download function you had previously tried as appropriate Information and Alerts This sensor has no data to download Please place your current sensor on the reader and try again You have attempted to download data from a Sensor which is not activated on your Reader Try again with your current activated Sensor See gt NOTE OvuSense User Manual Page 27 This sensor has already been activated Please use your current sensor or activate a new sensor You have attempted to activate a Sensor which is not known by your Reader but has already been activated on another Reader Try again with your current activated Sensor or activate a new Sensor This is the final cycle for this sensor A new sensor will be required for the next cycle Each personal Sensor can only be used for 1 year o
15. bstet Gynaecol 91 681 684 6 Wilcox AJ Dunson D 2000 The timing of the fertile window in the menstrual cycle day specific estimates from a prospective study BMJ 321 1259 1262 7 American Society for Reproductive Medicine 2013 Optimizing natural fertility Fertil Steril 100 631 637 Reference User Assistance Support amp Service supporte fertility focus com Ordering orders fertility focus com Web www ovusense com Part Numbers OvuSense Sensor M011 OvuSense Reader M010 EN User Manual M002 20FEB14 V6 1 EN For faulty or defective units please email support fertility focus com in advance for a return authorization number and address Sy fertility focus
16. charger is a mains isolating device Make sure the charger is accessible during use so the plug can be easily removed from the mains socket if necessary WARNING No serviceable parts are contained inside the Reader Sensor or the charger Modification repair or change of this equipment is not possible and is expressly forbidden by the manufacturer Damaged or defective units must be returned within two years of purchase for assessment by the manufacturer at the address identified in the User Assistance Section on the back page of this manual The OvuSense Sensor is a B type applied part according to the classifications defined in IEC 60601 1 Important Notes OvuSense User Manual Page 3 The data port on the back of the Reader is for manufacturer use only DO NOT attempt to plug in any cables Handling The surface of the Reader and the Sensor cradle should be regularly wiped with fresh paper tissue to keep it clean Care must be taken not to drop the Sensor If dropped check the seal around the centre ring for signs of cracking or breakage If found STOP use of the Sensor immediately DO NOT use the Sensor if any damage to the coating occurs or if the tail is broken In all cases of damage REPLACE the Sensor with a new one by contacting Service using the address in the User Assistance Section on the back page of this manual If you lose or damage your Sensor during a cycle you can simply place a new Sensor on the Re
17. ct Accept and press Confirm Alternatively select Cancel and press Confirm to go back to the Main menu without setting the first day of your cycle Page 10 OvuSense User Manual 3 2 At Night The Sensor is designed to be placed in the vagina overnight for the complete night If you wish to have sex remove the Sensor and thoroughly wash it before reinserting it lt q J 2 Place S 1 Press If you forget to insert the Sensor on one night do not worry continue to use the Sensor on subsequent nights If your Sensor is not already placed in the Sensor cradle on your Reader place it with the fins neatly aligned Press the StartT key to activate the Sensor You see this screen Choose Accept Gancel to continue Once your Sensor has been successfully activated you will see this screen Remove the Sensor from the cradle Thoroughly wash and dry it Insert the Sensor into your vagina before you go to bed OvuSense User Manual Page 11 3 3 In The Morning gt Remove the Sensor in the morning thoroughly wash it and dry it Then place the Sensor in mu the cradle on the Reader 2 Place 5 with the fins neatly aligned Sensor and press the Download A key e 3 Download Once the data download has started you will see this screen Wait until the data downloads As soon as the data download is complete you will see this screen Information and Alerts
18. d No you should ensure the Sensor is never used when you are bleeding or spotting What should do if forget to tell the Reader that I have started a new cycle The Reader will detect if you ve not entered the date of your first cycle when you carry out your first data download and automatically prompt you to enter the date the cycle started In all cycles after that it will detect any gap of 5 days and prompt you to enter the date the cycle started You can input the start date of a new cycle up to seven days after it has actually begun Simply choose New Cycle from the main menu and choose the relevant day started using the Sensor late and not on the first day after my period stopped What should I do As long as you input the correct start date of the cycle in which you are using the Sensor there is no issue with starting late in a cycle You can input the start date of a new cycle up to 20 days after it has actually begun The Sensor will measure from Page 30 OvuSense User Manual that point onwards and if ovulation has already passed then it will simply register that no ovulation was detected The data are still useful for future cycles Can I still use the personal Sensor if have a yeast infection or have been diagnosed with a sexually transmitted infection STI If you are undergoing treatment for a yeast infection or an STI you should not use the Sensor If you suspect you have an infection or condi
19. elligent filtering system which removes single fluctuations in temperature as a result of fever or for instance alcohol intake If you run a fever for more than three days you will need to tell the Reader The Your Health screen allows you to enter the date on which the fever started today yesterday 2 days ago 3 days ago 4 days ago 5 days ago q4444 4 20 days ago v Select the day and press Confirm Then select Accept and press Confirm Alternatively select Cancel and press Confirm to go back to the Main menu without making a selection Page 20 OvuSense User Manual 5 2 Set Up Set Date and Set Time Using the upa and down keys onthe Main menu highlight the Set Up option then Setup irm H press Confirm Then select Set Date or Set Time or Exit to return to the Main menu 36 To set the Date Select the Set Date option The current date will be displayed with the Year field highlighted Use the up 4 and down keys to change the current Year Press the Confirm key to set the Year Once the year has been set the Month field is highlighted Use the up 4 and down keys to change the current Month Press the Confirm key to set the Month Once the month has been set the Day field is highlighted Use the up and down keys to change the current Day Press the Confirm key to set the Day OvuSense User Manual Page 21 Once the Day has
20. for vaginal use such as K Y Jelly Durex Play Feel or Sensilube DO NOT use gels with flavour warming or cooling additives 1 Clean the Sensor as outlined in Section 2 2 Then wash your hands 2 Hold the Sensor where the tail joins the main body 3 Get into a comfortable position 4 The Sensor is inserted just as you would a tampon 4a and 4b 5 The Sensor tail is designed to hang outside of your body If you feel any discomfort the Sensor may not be placed far enough inside If this happens gently remove and try again OvuSense User Manual 2 4 Removing Your Sensor The Sensor tail is designed so that it cannot be inserted too high in the vagina To remove 1 First wash your hands with soap and warm water 2 Then check carefully with your fingers to see if you can feel the tail portion of the Sensor 3 Remove the Sensor by gently grasping and pulling on the tail If you cannot locate the tail 4 Get into a similar comfortable position as for insertion It is much easier to remove if you are squatting and relaxed 5 Then try to find the tail with one finger Once you have Page 8 OvuSense User Manual located it use your finger and thumb to hold the Sensor tail and pull it out If you still have a problem then seek medical advice You should remove your Sensor after each night s sleep If you forget to take your Sensor out when you first get up don t worry simply
21. ight days when you are most likely to be able to conceive from five days before ovulation until two days after ovulation Your Information OvuSense User Manual Page 15 If ovulation wasn t detected in any of the previous measured cycles then OvuSense will simply tell you ovulation is not yet detected If the fertile window is predicted OvuSense will continue to indicate your fertile window start day until you pass that day and enter the fertile window itself The screen will then indicate you are in your fertile window Your Information This is when you should Start to have sex as often as possible to maximize your chances of conception ren You will then enter your ovulation window and the screens will continue to appear in succession as outlined above Please note that OvuSense uses a fixed scale on the temperature graphs The curve will change as the cycle progresses and the temperature values are averaged out This smoothing helps you read and understand the graph 4 2 Previous Cycle If you select this menu option the screen will show you a graph of the information from your last cycle with information about when ovulation occurred or if it wasn t detected Your Information Page 16 OvuSense User Manual If ovulation occurred in the last cycle a thick blue vertical line indicates the day on which you ovulated Press Confirm to Exit to Main menu
22. nce started and has a unique code This message lets you know that you will need to purchase a new personal Sensor for your next menstrual cycle See User Assistance Section on the back page of this manual for ordering details This sensor has been used for 1 year Please use a new sensor For hygiene reasons each personal Sensor can only be used for 1 year once started and has a unique code This warning lets you know that you will need to purchase and use a new personal Sensor for a further year s use See User Assistance Section on the back page of this manual for ordering details Low battery warning Battery power is low Connect to the charger as soon as possible Charge the Reader as explained in Section 5 3 Page 28 OvuSense User Manual 7 0 Frequently Asked Questions What happens if I miss a night It is not a problem if you miss a night OvuSense will carry on using the data collected on the following night However you may get spaces on the cycle graph and for best results you should aim to use OvuSense most of the days when you are not menstruating until it tells you that you ve ovulated How long should keep the Sensor in overnight Minimum 2 hours but ideally 4 6 hours The Sensor will continue to gather data for the whole time until you place the Sensor on the cradle of the Reader and press Download It will not use any data over each 14 hour overnight period When should start using my Sensor
23. ns No the Sensor material is designed from specific biocompatible materials that prevent the growth of bacteria and simple washing with soap and water is sufficient to maintain this material properly Use of sterilizing solutions alcohol wipes or sanitizing gels may damage the Sensor material I am unwell and I m running a temperature Will this affect the readings No OvuSense has an intelligent filtering system that removes spikes in the data However if you have been running a fever for more than two days use the Your Health option on the main menu to input the date on which the fever started The personal Sensor is uncomfortable when I use it What should I do Check that you are inserting the Sensor properly so that a portion or all of the tail is outside of the vagina You can also use a small amount of aqueous based lubricant such as KY Jelly to help make insertion and wearing of the Sensor more comfortable If the discomfort persists then you should stop using the Sensor for a couple of days If the discomfort returns after you start using it again then you should stop using the OvuSense system altogether Page 32 OvuSense User Manual What should do if my Sensor is damaged or lost If your Sensor stops working either because it is damaged or faulty the OvuSense Reader will provide you with a message as indicated in Section 6 2 In this case you should contact Service as outlined in the Use
24. orning 11 4 0 Your Information 12 4 1 Current Cycle 12 4 2 Previous Cycle 15 4 3 Compare cycles 16 4 4 Trying For A Baby 17 4 5 Understanding Your Cycle 18 5 0 System Functions 19 5 1 Your Health what to do if you have a fever 19 5 2 Set Up Set Date and Set Time 20 5 3 Battery Indicator and Charging 23 6 0 Messages 24 6 1 Fertility information Messages 24 6 2 System Messages 25 7 0 Frequently Asked Questions 28 8 0 Reference Information 35 FCCID Z8YM009 V1 This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 This device must accept any interference received including interference that may cause undesired operation FC i Manufacturer Fertility Focus Ltd Unit 19D C 0088 University of Warwick Science Park Warwick Innovation Centre Warwick Technology Park Gallows Hill Warwick Fertility Focus Limited 2014 CV34 6UW United Kingdom T OvuSense User Manual Page 1 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 M
25. r Assistance Section on the back page of this manual If the Sensor is still within its 1 year lifespan Fertility Focus will replace the damaged or faulty Sensor free of charge If you lose the Sensor then you will need to purchase another one Why do I need to replace the Sensor after 1 year The Sensor is designed for optimum hygiene and to be used specifically for 1 year to provide an initial analysis of your ovulatory pattern If your ovulation timing is irregular or you are not ovulating on two or more of three consecutive cycles then you should seek further clinical advice That advice may lead to treatment with ovulatory stimulating drugs and or intrauterine insemination IUI and OvuSense can be used during that treatment phase by purchasing another Sensor If your ovulation timing is regular purchasing another Sensor will allow you to carry on using OvuSense to manage the timing of trying to get pregnant Do I need to use the Sensor for consecutive cycles OvuSense can provide you with valuable results straight away and continued use will improve your knowledge of your individual ovulatory pattern If ovulation is not detected in a particular cycle it s quite important to continue use to establish if this is a regular problem or like most women you occasionally miss an ovulation OvuSense User Manual Page 33 What if I forget to remove my Sensor in the morning Though you are advised to remove the Sensor each morning
26. round 2 3 days before you ovulate Your Information Page 18 OvuSense User Manual 4 5 Understanding Your Cycle The menstrual cycle can range from 15 to 45 days in length Most women and clinicians start with the assumption that regular cycles of about 28 days long will result in ovulation on day 14 Although studies have shown that only around 30 of women exhibit this pattern it is used for the illustration below Menstrual bleeding can last from 2 to 7 days and the first day of the menstrual bleed is the first day of the menstrual cycle The fertile window is usually up to 8 days in length and ovulation generally occurs a day or so before the end of the fertile window OvuSense also uses an ovulation window and this lasts from one day before ovulation until 2 days after ovulation 28 Day Cycle Day 14 Ovulation O 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 Fertile Window OvuSense is designed to help you whatever your cycle length and whatever day of the cycle on which you ovulate By predicting and detecting ovulation in each cycle OvuSense helps you to try and conceive at the best possible time each cycle If you are receiving diagnosis or treatment it helps maximize the efficiency of that intervention saving you valuable time in trying to get pregnant Your Information OvuSense User Manual Page 19 5 0 System Functions 5 1 Your Health what to do if you have a fever OvuSense has an int
27. take it out when you can and clean and dry it 2 5 Sexual intercourse and the Sensor The use of the Sensor should not prevent you from having sex as frequently as you wish Having sex will not affect that night s temperature recordings Remove your Sensor before sex Clean it and re insert it afterwards 2 6 Sensor Life Each Sensor has a life of one year and has a unique code After you have used your Sensor for 330 days a message will let you know that a new Sensor will be required for the next cycle If you need to continue using OvuSense after the first year then you can simply purchase an additional Sensor The Reader will store data for each cycle that you use the Sensor and will carry on doing so when a new Sensor is used OvuSense User Manual Page 9 3 0 Daily Use 3 1 Each New Cycle On the first day on which your full menstrual bleeding occurs including the first cycle of use you should tell the Reader that you have started your cycle Do not include days before this on which minor blood spotting occurs Using the up and down keys on the Main noae menu navigate to the New Cycle option then press the Confirm lt key Enter the first day of your menstrual cycle Pressing the down key steps you through the options today yesterday 2 days ago 3 days ago 4 days ago 5 days ago 5 days ago CEEE SEE SEE DEE SEE 20 days ago v Cancel Select the day and press Confirm Then sele
28. tion you should stop using the Sensor and consult your doctor Wait until all symptoms have cleared up and treatment finished before starting to use Sensor again Is the Sensor likely to make me more prone to yeast infections cystitis or other infections The Sensor is designed to be placed comfortably in the vagina and used only overnight during sleep It should be removed before going to the toilet or having sex and washed before being re inserted The Sensor has been designed specifically for repeated insertion in the vagina and is made of the highest medical grade materials already used in a number of other approved medical devices In addition the Sensor has undergone extensive biocompatibility and toxicity testing and passed all of these tests first time It therefore should cause no irritation and nor should it increase the chances of infection However you should observe the washing steps before and after each use and if you do notice any signs of irritation or infection you should stop using the Sensor and consult your doctor OvuSense User Manual Page 31 I think the Sensor is causing me to have yeast infections cystitis or another infection What should do Stop using the Sensor and if the irritation is still noticeable after more than 48 hours you should consult your doctor If you notice a return of symptoms then you should stop using OvuSense altogether Can I sterilize the Sensor using sterilizing solutio
29. tomorrow Sometimes ovulation today It may just say you are now in your ovulation window You may see all of these notifications or just one or two of them depending on what OvuSense has seen in your temperature curves This is the vital information you need to help you Page 13 Your Information Cm You are now in your ovulation window Ovulation tomorrow Previous Compare Exit a 0 5 10 15 20 25 30 35 40 then or Your Information C You are now in your ovulation window Ovulation today Previous Compare Exit E 0 5 10 15 20 25 30 35 40 then or Your Information m You are now in your ovulation window Previous Compare Exit 0 5 10 15 20 25 30 35 40 understand your personal cycle pattern y Page 14 OvuSense User Manual Three days after you have ovulated you will receive u a message telling you the date of ovulation You can now stop using the Sensor during the current cycle if you wish Simply keep OvuSense on charge then input the start of your next cycle on the first day your bleed begins again If you fail to ovulate around the expected time during a particular cycle you ll need to continue using the Sensor to ensure that ovulation is detected if it does occur late Once you begin your second cycle and for each successive cycle OvuSense will predict the start of your fertile window for that coming cycle The fertile window is the e
30. ur most fertile Nonetheless you should be aiming to have sexual intercourse every 2 3 days throughout the cycle because that improves the quantity and quality of sperm Can I give OvuSense to a friend The Sensor is for your personal use Sharing it with other women may present a hygiene risk and will invalidate your personal data The OvuSense Reader can also only be used by a single user and with a single Sensor at any one time Can OvuSense help me if I have recently ceased contraception It takes the female body a varying amount of time to re establish a normal hormone balance after you stop hormonal methods of contraception or have an IUD removed The length of time it takes depends on the type of contraceptive and your individual body As the hormone patterns start to normalize regular menstruation will return and eventually so will ovulation However this may take up to 9 months with hormonal methods During this time OvuSense may be able to help by showing you whether you are ovulating but the fertile window prediction may be of less use as the cycle length and ovulation timing is likely to vary greatly especially in the first three cycles OvuSense User Manual Page 35 8 0 Reference Information Storage Environment The OvuSense Reader and Sensor require no special storage conditions but should ideally be stored in a dry environment with an ambient temperature of 20 C 65 0 F or 5 C 41 F The Reader
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