Fertility Focus M009-V1 OvuSense Advanced Fertility Monitor User Manual manual

Fertility Focus Ltd OvuSense Advanced Fertility Monitor manual

manual

OvuSenseTM Advanced Fertility MonitorUser Manual
OvuSense™User ManualContentsPrecautions   11.0 Who should use OvuSense?  21.1 Using the OvuSense system  21.2 Your personal Sensor  31.3 Sexual intercourse and the Sensor  31.4 Cleaning the Sensor  41.5 When to use the Sensor  41.6 Inserting your Sensor  51.7 Precautions when using the Sensor  52.0 The Reader  62.1 Switching on the Reader  62.2 Setup (set time and date)  73.0 Using OvuSense   83.1  New  cycle  -  what  to  do  when  you  start  a  new menstrual cycle  83.2 At night   93.3 In the morning  104.1 Your health - what to do if you have a fever  115.0 Your  Information  - what  the  Reader  can  tell  you about your fertility status  115.1 Previous cycle  125.2 Compare cycles  – the Reader enables you to review your previous cycles  126.0  Using  the  fertility  information  provided  by OvuSense to optimise your fertility  126.1 Detailed Cycle Information   146.2 Fertility information warnings  147.0 Warning messages   158.0 Personal care  169.0 Troubleshooting   17M Fertility Focus LtdUnit 19D  University of Warwick Science Park Warwick Innovation CentreWarwick Technology ParkGallows Hill, Warwick CV34 6UW, United Kingdom0123C
Page 1OvuSense™ User ManualPrecautions Safety Precautions The plug-in charger is the mains isolating device for OvuSense, and must be easily accessible during use. WARNING: No modification of this equipment is allowed. No serviceable parts contained inside in the Reader, Sensor or charger units.  Repair must be attempted by authorised service personnel  only. Damaged or defective units, must be returned to the manufacturer for repair at the address identified at the end of this User Manual.   Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.ChargingWhen the charging unit is plugged into the OvuSense Reader and the mains is switched on, the Reader will remain permanently on with the screen lit until it is fully charged. It is not recommended to unplug the charging unit before the Reader is fully charged. Intended UseThe OvuSense advanced fertility monitor is intended for measuring and recording body temperature on a nightly basis during the non-menstruating phases of the monthly female reproductive cycle.  OvuSense detects the presence and absence of ovulation, as well as predicting the fertile period for the next monthly cycle. Contra-Indications Not to be used during menstruation.   OvuSense is not designed to be used as a contraceptive device. OvuSense is not designed to be used as a method for detecting or confirming pregnancy. Use of the contraceptive pill, any other hormonal contraceptive, or intra-uterine devices at the same time as use of OvuSense will invalidate the data collected.For further precautions please refer to Section 1.7The Ovusense Sensor is considered to be a B-type applied part, in terms of the classifications defined in IEC 60601-1
Page 2OvuSense™ User ManualOvuSense  gives  you  daily  information  about  your body  and  the  changes  that  occur  around  the  time  of maximum  fertility.  This  information  is  collected  as you sleep through your personal OvuSense Sensor and is uniquely yours.  Regular use of the personal Sensor during  sleep  will  build  up  a  picture  of  your  fertility information which you can review, cycle by cycle, and will  also  allow  the  period  of  optimum  fertility  to  be identified to help you to achieve pregnancy. 1.1 Using the OvuSense systemOvuSense has two parts – a personal Sensor shaped like a small tampon, and a Reader, the box which stores the Sensor and which provides information on a display.The Reader 1.0 Who should use OvuSense?Women who are wishing to become pregnant can use the OvuSense system to identify the time during their menstrual (oestrus) cycle when they are most likely to be fertile. OvuSense takes a number of measurements of body  temperature taken throughout the night to work out the time of maximum fertility.The menstrual cycle can range from 20 to 45 days in length, but most women have a cycle length of about 28 days*. Menstrual bleeding can last from 2 to 7 days (show as purple in the chart below), and the first day of the menstrual bleed is the first day of the menstrual cycle. Ovulation usually occurs at between 14 and 19 days into the cycle, but this is likely to vary with your individual cycle length.Period                Ovulation(bleeding)        1  3  5   8   10   12   14   16   18   20   22   24   26  28*If your  know that your cycle routinely  falls outside of these parameters seek medical advice about whether OvuSense  will  work  for  you.  If  you  do  not  have  a regular  cycle  length,  OvuSense  may  still  provide you with information about your menstrual cycle and ovulation.Personal Sensor CoverConrmSelect / UpSelect / DownDownload LCD Display
Page 3OvuSense™ User Manual1.2 Your personal SensorYour  personal  Sensor  is  included  in  the  OvuSense Starter Pack. Each personal Sensor has a life of three menstrual  cycles  and  has  a  unique  code.  After  you have  used  your  personal  Sensor  for  two  cycles,  a message will let you know that you can only use it for one more cycle, and if you try to use the Sensor in a fourth cycle a message will warn you that this is not possible (see section 8 for these warnings). The Reader will  accumulate  data  for  each  cycle  that  you  use  the personal Sensor, and will continue to accumulate data when a new personal Sensor is used. You need to wait until a new menstrual cycle before you start using the OvuSense system. On the first day of your menstrual bleeding, you should tell the Reader that you have started your cycle  -  please  see  section 5. You will need to wait until the first day after your menstrual  bleeding  stops  before  you  can  use  your personal Sensor.The  personal  Sensor  has  been  designed  to  rest comfortably  within  you  vagina  and  measures  the changes in your body that take place during the night time. It should be inserted just before you go to bed on the first day after your menstrual bleeding stops. The Sensor is for your personal use, DO NOT share it with other women as this may present a risk of disease, and invalidate the personal data which will be used to work out your specific time of maximum fertility. When you are not using the personal Sensor, clean it and store it in its  cradle on the Reader with  the lid closed – this will keep it clean and secure. A new personal Sensor can be purchased from your local approved supplier.  If in doubt contact Fertility Focus by email at: orders@fertility-focus.com. 1.3 Sexual intercourse and the SensorThe  use  of  the  Sensor  should  not  prevent  you  from having  sex  as  frequently  as  you  wish.  Remove  your personal  Sensor  before  sex  and  then  clean  it  and  re-insert it after intercourse.DO NOT leave the device in place in the vagina during sex as this may present a risk to you and your partner.Personal Sensor sitting in cradleStart Record
Page 4OvuSense™ User Manual1.4 Cleaning the SensorBefore and after use, the Sensor should be thoroughly cleaned by washing it in hand-hot soapy water (at least 40°C). Prepare the water by pouring a small amount of washing up liquid  into a basin of hand-hot water.  Dip the  Sensor  in  the  soapy  water  and  rub  it  thoroughly with fingers for 2 minutes. Make sure that you wash all parts of the personal Sensor, including all of the tail and the area where the tail joins the main part of the Sensor.  After washing, rinse all parts of your personal Sensor thoroughly for 2 minutes in clean tap water to remove any soap residue, and then dry the Sensor on a clean towel or clean tissue paper. You will need to clean your personal Sensor twice each day1st time - once after you have used it overnight so that it is clean when you place it on the Reader.2nd time - so that it is freshly cleaned before you insert it.DO  NOT  clean  the  Sensor  in  strong  disinfectants  or alcohol  or  with  antibacterial  or  disinfectant  wipes.  If you  use  a  soap  containing  antibacterials  –  for  example anti-acne soap or carbolic soap, do not  use this on your personal Sensor.DO NOT subject it to high temperatures (for example by boiling or microwave) as this will damage your personal Sensor and invalidate the measurements made. DO  NOT  use  the  Sensor  if  any  damage  to  the  coating occurs, or if the tail should become broken. REPLACE it with a new one.You cannot  swap Sensors  in mid  cycle.  If your personal Sensor is lost or damaged mid way through your cycle you will need to start a new cycle with a new personal Sensor. Information downloaded from the use of a previous Sensor will be retained in the memory of the Reader.1.5 When to use the SensorAt night  - Inserting your Sensor - you should insert your  personal  Sensor  just  before  you  go  to  bed,  and after you have showered or had a bath.In the morning - Removing your Sensor - you should remove your personal Sensor in the morning when you first get up. If you forget to take your Sensor out when you first get up, don’t worry, simply take it out when you have an opportunity and clean and dry it. OvuSense  works  most  effectively  if  you  have  a regular sleeping pattern. If, for example, you work shifts that change the time of your sleep, or if you travel  and  alter  your  sleep  to  suit  different  time zones,  this  may  invalidate  the  data  collected  by OvuSense.
Page 5OvuSense™ User Manual1.6 Inserting your SensorIf  you  are  familiar  with  using  sanitary  tampons  then insert the personal Sensor as you would a tampon.If you are not familiar with sanitary tampons - before you insert the personal Sensor for the first time, gently open your labia (the lips which cover the entrance to your vagina) and explore the entrance to your vagina. This is where  the Sensor will  be inserted. Hold  your Sensor where the tail joins the main body,  and, with your vaginal muscles relaxed, insert the Sensor with a slight twisting motion until only the tail is visible. If  you  find  that  the  Sensor  is  ‘dry’  to  insert,  apply a  very  small  amount  of  lubricant  gel  approved  for vaginal  use  such  as    KY  jelly®,  Durex®  play  (not tingle), Sensilube®, Astroglide® or Condomi LUB®. The length of the Sensor tail is such that it cannot be “inserted too high in the vagina”. However, if the tail of  the  Sensor  should  withdraw  inside  the  vagina,  it can usually  be located with  gentle exploration in the vagina. If it is still not identified then please see your doctor.1.7 Precautions when using the SensorPersonal  care  -  Clean  your  personal  Sensor  before each insertion and insert the Sensor before you go to bed and NOT a period of time before (for example, do not insert it before you go out in the evening if you are worried you will forget to insert it later – it is designed only for use when you are sleeping). The Sensor is not designed for daytime use, and if you do use the Sensor during the day it will not produce valid results.Urinating - The Sensor can be left in place when you urinate. Women vary greatly in shape, and some women may  find  that  the  Sensor  falls  out  if  they  strain  to urinate, or if they walk about during the night.  If this happens occasionally, clean the Sensor and re-insert it. If you find that the Sensor falls out on a regular basis whilst you are sleeping then it may not be possible for you to use the OvuSense system effectively.Personal health - 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. DO NOT use the personal Sensor during your menstrual bleed, but should ‘spotting’ or an unexpected bleed start, simply stop using your Sensor until this bleeding stops.Toxic Shock Syndrome- Use of the Sensor when you are having a menstrual bleed is not recommended and will not produce valid fertility monitoring results. As with the use of sanitary tampons, there may be a small risk of toxic shock syndrome – a rare condition caused
Page 6OvuSense™ User Manualby  the  bacterium  Staphylococcus  aureus  growing  on blood or  fluids in the vagina. If you feel ill or have a  high  temperature  (above  39˚C),  muscular  pains, headaches,  vomiting,  diarrhoea,  or  if  a  skin  rash appears  stop  using  the  personal  Sensor  immediately and see your doctor. 2.0 The ReaderThe  Sensor  is  able  to  send  the  data  it  has  collected when  it  is  placed  in  the  cradle  on  the  Reader.  The Sensor does not send any data unless it is placed in its recess on the Reader AND the download button on the Reader is pressed. The  Reader  then  provides  you  with  information  on your  menstrual  cycle  and  also  indicates  the  time  of maximum fertility to help you to conceive. The Reader contains a rechargeable battery so that you can  use  it  whilst  travelling  and  away  from  a  power supply.  Recharge  the  battery  when  the  display  says ‘Battery power is low, connect to the charger as soon DownloadButtonas possible’The  Reader  will  not lose  information  already stored if the main battery becomes  flat,  but  it  will not  be  able  to  download new  measurements  until the battery is re-charged. Keep your Reader clean. It is NOT designed to be immersed in water, but the surface, particularly the cradle for the Sensor should  be  wiped  with  clean  paper  tissue to  keep it  clean.  Disinfectant  or  antibacterial  wipes  can  leave  a residue on your Sensor and are NOT recommended.2.1 Switching on the ReaderThe Reader is designed to be held in the palm of one hand and operated with the other.  When the charging unit  is  plugged  into  the  OvuSense  Reader  and  the mains is switched on, the Reader will come on and will remain on with the screen permanently lit until the unit is fully  charged.   When not  charging, press any key to switch the Reader on. The screen will light up and
Page 7OvuSense™ User Manualdisplay the main menu. You can switch the Reader on at any time to review your fertility information.  If the screen fails to light within a few seconds, please refer to the troubleshooting guide. If the unit is not charging, the  Reader  will  automatically  turn  itself  off  after  5 minutes  to  save  battery  power  if  there  is  no  further action. You  can  switch  the  Reader  on  at  any  time  to date, or  Set time, or   Exit  to return to main menuTo  set  the  Date,  Select  the  ‘Set  date’  option.  The current  date  will  be  displayed  with  the  “Year”  field highlighted:review your fertility information. Using the up and down  keys, and the  Confirm  key, you can  navigate  and choose  the  option on each screen.  When you first unpack the Reader it will need to be charged overnight.  When you first turn it on you may need to set the date and time. The main menu leads you to the following screens2.2 Setup (set time and date)Using the  up and down    keys  on the    Main  menu  - highlight  the  Set Up  option,  then press  Confirm   . Then  select  Set Use the up and down  keys to change the current Year. Press the Confirm   key to set the “Year”. Use the up and down  keys to change  the  current  Month.    Press the  Confirm     key  to  set  the “Month”. shown  in  full  with the day of the week. The date is now set and you can Accept or Cancel  to return to the Setup menu.Once  the  year  has  been  set,  the  “Month”  field  is highlighted: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”. Once  the  day  has  been  confirmed,  the  date  will  be
Page 8OvuSense™ User ManualTo set the TimeUsing 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:Once you have finished setting up Date and/ or Time, use the down  key on the  Setup menu to highlight the Exit option,  then press Confirm   .You will then return to the Main menu.Note:  OvuSense  will  not  automatically  make  changes for  daylight  saving  or  timezones.   You  can  change  the time +/- 1 hour using the instructions above to allow for daylight saving time without this affecting your fertility information. However, greater time zone changes over 3 hours  will  cause  errors  in  determination  of  your  fertile time, and the sleep pattern changes that you will experience will  also  make  determination  of  your  fertile  time  less likely  to  be  accurate.  OvuSense  works  most  effectively if  you  have  a  regular  sleeping  pattern.  If,  for  example, you  work  shifts  that  change  the  time  of  your  sleep,  or if  you  travel a lot  and  alter  your sleep  to  suit  different time zones, this may invalidate the data collected by the OvuSense system.3.0 Using OvuSense 3.1  New  cycle  -  what  to  do  when  you start a new menstrual cycleYou need to wait until a new menstrual cycle before you  start  using  OvuSense.  On  the  first  day  of  your menstrual bleeding, you should tell the Reader that you have started your cycle. You will need to wait until the first  day  after  your  menstrual  bleeding  stops  before you can use your personal Sensor.  Using the  up and down    keys, select  whether  you want to use 24 hour or  12  hour  clock. For  example  23:00 or  11.00  pm,  then press Confirm The  "Hours"  field  is  then  highlighted.  Using  the    up 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 Setup menu.
Page 9OvuSense™ User Manualmaking a selection.If you decide to stop using OvuSense for a time – for example,  if  you  are  going  on  holiday  or  travelling and  don't  wish  to  take  it  with  you  –  then,  on  the last day of  your  current  cycle, go through the  stages above and  select Today  as if you were  going to start a  new  cycle  of  recording  –  and  then  do  not  use  the personal Reader. If you do this, the system will detect that  you  have  stopped  using  it  during  this  cycle, but  will  also  know  that  the  last  cycle  has  ended.  To  re-start  using  the  OvuSense,  wait  until  a  new menstrual cycle starts and then follow the steps above to indicate to OvuSense that a new cycle has started.  Then simply start daily recording again.3.2 At night ‘Start’  your  personal  Sensor  before  you  insert  it  and before going to bedWake up the Reader by pressing any key.  (If the Reader will  automatically  turn  itself  off  after  5  minutes  if there is no further action).You  need  to  ‘Start’  your  personal  Sensor  before  you insert it and before you go to bed so that it knows when to collect data when you are asleep.Using  the  upand down    keys  on the  Main  Menu, navigate  to  the New  Cycle  option, the    press  the  Confirm  key.Please  enter  the  first  day  of  your  menstrual  cycle.  Pressing  the  down  key,  cycles  you  through  the options Today , 1 day ago, 2 days ago, 3 days ago, 4 days ago, 5 days ago, 6 days ago, 7 days ago.Please note – the first day of your menstrual cycle is the first  day  on  which  a  full  bleed  occurs  –  do  not  include days preceding this on which minor blood spotting occurs. Today    Yesterday   2 days ago   3 days ago  4 days ago   5 days ago    6 days ago   7 days ago Select  the  day  and  press  Confirm    .    Then  use  the upkey to select Accept, press Confirm     to  set  the  first day of your cycle, or select Cancel  and press Confirm    to  go  back  to  the  Main  Menu  without
Page 10OvuSense™ User ManualAfter  you  have cleaned  and  dried your  Sensor  – place  it  on  the Reader  with  the fins  neatly  aligned in  the  Sensor  well and  press  the  () Start  key.  You  will need  to  wait  about  10  seconds  for  the  Sensor  to  be detected.If  you  forget  to  insert  the  Sensor  on  one  night,  do not  worry,  continue  to  use  the  Sensor  on  subsequent nights. Please  note  –  the  quality  of  fertility  information relies  on  regular  use  of  the  personal  Sensor,  and so repeated missed nights will reduce the accuracy of  the  information  that  the  advanced  fertility monitoring  system  can  provide  you  with.  Also remember  that  use  of  the  personal  Sensor  should not  prevent  you  from  having  sex.  Simply  remove your personal Sensor before sex and clean and re-insert it after sex.3.3 In the morningCollect the data from your personal Sensor using the Reader. Wake up the Reader by pressing any key. (If the  Reader  will  automatically  turn  itself  off  after  5 minutes if there is no further action). 3. Start1. Pressa key2. Place Sensor3. Download1. Pressa key2. Place SensorOnce  your  Sensor has  been  activated, you will receive the following  message. Insert your personal Sensor. Have a good night’s sleep!If  you  have  not placed  the  Sensor correctly  you  will see  the  following screen.    Follow instructions  until your  Sensor  is successfully activatedAfter  you  have cleaned  and  dried your Sensor,  place it  on  the  Reader with  the  fins neatly  aligned  in the  Sensor  well and  press  the  ()  (Download) key.
Page 11OvuSense™ User Manualensure  that  an  accurate  measurement  of  fertility  can be made.Once the data download has started, you will see the following screen.4.1 Your health - what to do if you have a feverYou will need to tell the Reader if you run a temperature as a result of a fever.The "Your health" screen allows you to enter the date if you have had a fever during the last cycle. A fever may result in an unusually high body temperature, and this  information  needs  to  be  taken  in  to  account  to Then use the upkey to select Accept, press Confirm   ,  or  select  Cancel  ,  and  press  Confirm    to  go back to the Main Menu without making a selection.5.0 Your Information - what the Reader can tell you about your fertility statusThe  "Your  Information"  screen  allows  you  to  review the  information  collected  in  your  current  cycle.  The display  will  update  at  each  point  when  sufficient data has been collected, but not necessarily each day. Wait  until  the  data downloads. As  soon  as  the data  download  is complete  you  will see  the  following screen. Today    Yesterday   2 days ago   3 days ago  4 days ago   5 days ago     Select  the  day  and press Confirm   Using the up and down  arrows, and the Confirm    key, you can navigate up and  down  between Previous  cycle  and Compare cycles
Page 12OvuSense™ User ManualAs  shown  in  the  example  on  the  previous  page, OvuSense  can also tell you that "You will be fertile from (date) to (date)".   This is the time of optimum fertility, and if you are planning to get pregnant, then you should have sex as often as you wish during this time.  It can also be used to review information for up to your three previous cycles.5.1 Previous cycleIf  you  select  this  menu  option,  the  screen  will  show you a graph of the information from your last cycle.Press Confirm   to Exit to main menu.5.2 Compare cycles  – the Reader enables you to review your previous cyclesIf you select this menu option, the screen will show you a graph of the information from your last 3 recorded cycles.Upper  Graph  - Your last full cycle recorded        Middle Graph - The graph for two cycles ago       The  blue  band indicates  the  day on  which  you ovulated.The  blue  band  will only  be  shown when  a  full  cycle has  been  recorded. Lower Graph - The graph for three cycles agoPress Confirm   to Exit to main menu.6.0  Using  the  fertility  information provided  by  OvuSense  to  optimise  your fertilityFertility  is  controlled  by  many  factors  including  the vitality  of  the  egg  and  of  the  sperm,  the  timing  of the  joining  of  sperm  and  the  egg,  the  environment of  the  uterus  and  fallopian  tubes  and  by  hormonal and  biochemical  factors.  The  data  collected  by  your personal Sensor is used to build up a personal picture of  your  menstrual  cycles,  of  your  time  of  ovulation and of the time of your maximum fertility. The OvuSense provides the following prompts that you are in your period of optimum fertility -
Page 13OvuSense™ User ManualPrecautions Safety Precautions The plug-in charger is the mains isolating device for OvuSense, and must be easily accessible during use. WARNING: No modification of this equipment is allowed. No serviceable parts contained inside in the Reader, Sensor or charger units.  Repair must be attempted by authorised service personnel  only. Damaged or defective units, must be returned to the manufacturer for repair at the address identified at the end of this User Manual.   Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.ChargingWhen the charging unit is plugged into the OvuSense Reader and the mains is switched on, the Reader will remain permanently on with the screen lit until it is fully charged. It is not recommended to unplug the charging unit before the Reader is fully charged. Intended UseThe OvuSense advanced fertility monitor is intended for measuring and recording body temperature on a nightly basis during the non-menstruating phases of the monthly female reproductive cycle.  OvuSense detects the presence and absence of ovulation, as well as predicting the fertile period for the next monthly cycle. Contra-Indications Not to be used during menstruation.   OvuSense is not designed to be used as a contraceptive device. OvuSense is not designed to be used as a method for detecting or confirming pregnancy. Use of the contraceptive pill, any other hormonal contraceptive, or intra-uterine devices at the same time as use of OvuSense will invalidate the data collected.For further precautions please refer to Section 1.7The Ovusense Sensor is considered to be a B-type applied part, in terms of the classifications defined in IEC 60601-1
Page 14OvuSense™ User ManualThe  blue  band  indicates  the  day  on  which  you ovulated.The blue band will only be shown when a full cycle has been recorded.To  maximise  your  chances  of  becoming  pregnant,  you should aim to have sex without contraception as often as you wish during the times indicated by OvuSense system. 6.1 Detailed Cycle Information When  you  start  a  New  Cycle,  OvuSense  produces 6.2 Fertility information warningsExamples  (each  warning  will  have  a  similar  screen with wording detailing the warning)detailed  information  on the  length  of  your  cycle and  ovulation.  This  will help  you  and  your  doctor to  better  understand  your fertility, and the best course of  action  to  help  you  get pregnant.Insufficient data to predict fertility at this timeThere  are  too  many  nights of missing data within this cycle  to  be  able  to  detect ovulation.Ovulation was not detected in the last cycleIt  was  not  possible  to determine  a  time  of ovulation in the last cycle.Other exmaples:Your last cycle length was (XX) days; this is unusually short. The data collected indicates that you have had an unusually short menstrual cycle – a Doctor’s opinion should be sought if this occurs regularly.
Page 15OvuSense™ User ManualYour last cycle length was (XX) days; this is unusually long. The data collected indicates that you have had an unusually  long  menstrual  cycle  –  a  Doctor’s  opinion should be sought if this occurs regularly.Potential fertility problem. The data collected by the OvuSense indicates that there are unusual features of your menstrual cycle and calculated time of ovulation. OvuSense detects that within the last three cycles your data suggests that you may have had two incidents of any of the following;Ovulation not detectedUnusual cycle lengthsCycles with a short post-ovulatory phase7.0 Warning messages  Sensor  not  detected.  Please  ensure  the  Sensor is  located  correctly  on  the  Reader  and  try  again. The personal Sensor may not be located firmly in the cradle, try placing it again. Make sure that the fins on the Sensor are properly aligned in their recess on the Reader cradle. A problem has been encountered with this personal Sensor.  Please  consult  the  instruction  booklet supplied with the Sensor.  A  fault  has  been  detected in  the  personal  Sensor.  Re-start  the  Reader  and replace  the  personal  Sensor  firmly  in  the  cradle. If  this  message  persists  at  the  next  start  up,  please contact the supplier.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  3 menstrual cycles  once started and has a unique code. This warning lets you know  that  you  will  need  to  purchase  a  new  personal Sensor for your next menstrual cycle.This Sensor has  been  used for three cycles. Please use a new Sensor. Each personal Sensor can only be used  for  3  menstrual  cycles  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 any further cycles.Low battery warning: Battery power is low. Connect to the charger as soon as possible. Plug the charging unit  into  the  Reader  and  switch  on  the  mains.  The Reader will remain permanently on with the screen lit until it is fully charged.
Page 16OvuSense™ User Manual8.0 Personal careWhat happened ActionIf you experience repeated difficulty  or  discomfort during  insertion,  or discomfort,  irritation or  a  vaginal  discharge during use of the personal SensorDO  NOT  continue  to use  the  personal  Sensor. Consult your doctor.Blood  ‘spotting’  or  an unexpected  menstrual bleed startsDO  NOT  use  the personal  Sensor  during your  menstrual  bleed. Should  ‘spotting’  or  an unexpected  bleed  start, stop  using  your  personal Sensor until this bleeding stops.If  you  feel  ill  or  have  a high  temperature  (above 39˚C),  muscular  pains, headaches  or  vomiting or diarrhoea, or if a skin rash appears –STOP  using  the  personal Sensor  immediately  and see your doctor.Use  of  the  personal Sensor  when  you  are having a menstrual bleed is not recommended and will  not  produce  valid fertility  monitoring results. As  with  the  use of  sanitary  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),  muscular  pains, headaches  or  vomiting or  diarrhoea,  or  if  a skin  rash  appears  – stop  using  the  personal Sensor immediately and see your doctor.
Page 17OvuSense™ User Manual9.0 Troubleshooting What happened Likely cause RemedyScreen  fails  to light  up  when  a key is pressed.Battery  may be  completely discharged.Plug  the charging  unit into  the  Reader and  switch on  the  mains. The  Reader will  remain permanently  on with  the  screen lit  until  it  is fully charged.Screen  fails  to light  up  when the charging unit is connected.Battery  may  be damaged.Check  charging unit  is  plugged into  Reader and  mains  is switched  on.    If screen still fails to  light,  contact the  Service Centre  for  a replacement unit as  indicated  on back page.0123CSensor Reorder Number MXXXSupport and Complaints     support@fertility-focus.com    Ordering            orders@fertility-focus.com      Webwww.fertility-focus.comInstruction ManualM002-30NOV11-V1.4-ENFaulty or defective units must be returned to the following Service Centre address.  Please email support@fertility-focus.com in advance for a return authorisation number: Fertility Focus LtdService CentreUnit 3, Coped Hall Business ParkWootton BassettWiltshire SN4 8DPUnited Kingdom

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