user manual Geratherm ovu control
Contents
1. Store at rel Humidity between 10 and 95 R H o Only for in vitro use external use storage between 0 Cand 70 C Manufacturer Do not dispose in do mestic household waste P L Attention consult accompanying docu ments in 12 GB INDEX EXPLANATION OF TERMS Product for Personal Use A product for personal use refers to any product that can be applied to the purpose specified by the manufacturer by any amateur in the home environment Electromagnetic Compatibility The electromagnetic compatibility refers to a usually desirable state that technical devices do not affect each other by disturb ing and unwanted electrical or electromagnetic effects Ovulation The expulsion of the unfertilized egg from the ovary is called ovulation Ovulation takes place in about the middle of the fe male menstrual cycle and is essential for the fertilization of the ovum by a sperm in the fallopian tube Progesterone content Progesterone belongs to the group of sex hormones This is mainly generated during the second phase of the menstrual cy cle and in much higher amounts during pregnancy Estrogen content Estrogens are the primary female sex hormones Estrogens promote the maturation of an egg capable of being fertilized By estrogen the endometrium is well supplied with blood The cervix opens and the cervical secretion is permeable to sperm LH concentration Luteinizing hor2. and 15 days before the next menstrual period the rising blood estrogen levels lead to ovulation The biological properties of egg cells only permit fertilization within approximately 24 hours after ovulation Because the male sperm have a life span of up to 72 hours in general a conception in a time frame of approximately 2 days before and 1 day after the actual ovulation is possible Geratherm ovu control was tested in a field study against a urine fertility rapid test The Geratherm ovo control possessed a high level of agreement in determining the fertile infertile days Furthermore in a medical study of patients the following was confirmed Geratherm ovu control is capable of showing a positive test result at an LH concentration of about 4 mlU ml this concen tration value is the minimum required for an ovulation trigger 5 PRECAUTIONS 1 Doo ws m e 11 Certain medications or hormone treatments as well as smoking acute inflammations in the mouth or throat and alcohol can temporarily alter the composition of saliva and thereby affect the result Before applying the saliva check that the outer smooth surface of the lens is clean For reasons of hygiene and health it is recommended that the device be used by one individual only Do not expose your device to intense heat or cold Never immerse the device in water or other fluids Do not clean it under running water Do not dr
3. interpretation of the result 14 GB CERTIFICATE OF GUARANTEE Geratherm guarantees the ovu control against any manufac turing defect for one year from the date of purchase if it is re turned to the dealer from whom it was purchased During this period the unit will be repaired or replaced free of charge if the fault is due to defective design or assembly This guarantee does not cover any damage or defect caused by improper handling resulting from use that is not in compliance with these instructions or caused by unauthorised attempts to repair it Your local dealer cannot declare this manufacturer s guarantee invalid but may expand it by additional guarantees at his discretion and at his own expense DAG Gf purchases u u L ier b S u az Gua Dealer s signature einen te teens Geratherm Medical AG FahrenheitstraRe 1 D 98716 Geschwenda Germany www geratherm com FERTILITY TEST Geratherm ovu control GT OVU04 GB 15
4. it may happen that the saliva is too thick If this is the case the result of the test may be false Then run the test again later in the afternoon or when the saliva is liquefied In this case the test must be con ducted no earlier than 3 hours after eating drinking brush ing teeth or smoking 3 Clean the lens with a dry cloth before and after each use 4 To stimulate the flow of saliva you can lightly bite your tongue GB 7 USE Step 4 casing of the device Place the lens with the completely dried drop of saliva inside the Step 5 A D C J gt Step 6 Push the button to activate the light switch If necessary remove any visu al aids While pressing the light switch look through the upper section of the device with the inserted lens so as to view your test result Look closely and carefully at the sample in order to evaluate your result correctly Note Should no structure at all be visible when you examine the sample re move the optical system from the cas ing and wait a few more minutes until the sample is completely dry before repeating the test After each use clean the lens Use the supplied cleaning cloth or any other clean cloth Do not immerse the Geratherm ovu control in water Place the blue cap back on after use INTERPRETATION OF RESULTS It is scientifically proven that there is a direct correlation be tween the increase in oestrogen levels and th
5. values recorded in an evaluation calendar are important for determining the fertile phase Carefully filled in record sheets provide important diagnostic in formation and you should always take them with you when you visit your doctor Start recording on the first day of a menstrual period New evaluation calendars can be downloaded from the Geratherm homepage by clicking on the following link http www geratherm com 10 GB EVALUATION CALENDAR Example for the month of January Bujpaayg jenysuausaju popad uua ssa amag Jequeydes isnBny eunr ken udy usen Avenages e i oe ez az WZ SZ wz cz vt OZ GL A OF S vk k M OF O4UOD NAO 1A pu leo Apinae AW Wuye Avenuer GB 11 CLEANING Clean the lens glass substrate with a dry lint free cloth A Do not clean the lens under running water Do not use soap or detergent to clean the lens DURABILITY Residues may disrupt the crystal formation The product can be used over 50000 hours with daily use tak ing account of changing batteries SYMBOL INDEX Read Instructions 4 Lot Number Protect from moisture B Serial number
6. SALIVA BASED FERTILITY TEST Geratherm Ovu control Geratherm ovu control INSTRUCTION MANUAL Geratherm ovu control GT OVU04 C 0197 GB 1 CONTENTS Purpose lt i eite kusa EE 3 Description of the device Technical data General information Use 5 Interpretation of results Evaluation calendar Cleaning Durability Symbol index Index explanation of terms Disposal Warranty Certificate of guarantee u uu Please read these instructions carefully 2 GB PURPOSE OF USE Geratherm ovu control is a saliva test for self testing for deter mining the fertile and infertile days A This product is specifically not a contraceptive The reliability of the method is dependent on correct following of the instructions and correct evaluation of the results It is strongly recommended that you consult your doctor if you begin to plan a family DESCRIPTION OF THE DEVICE The Geratherm ovu control consists of four components the casing the lighting system the optical system lens and the lid Lens Battery cover On Button for Illumination GB 3 TECHNICAL DATA Magnification Dioptre Batteries Light source Dimensions Weight Operating and storage between uses conditions Temperature Air humidity Atmospheric pressure Transport and stor
7. age conditions Temperature Air humidity Atmospheric pressure IP code protection rating Quality guarantee Geratherm is certified in accordance with Council Directive 98 79 EG and EN ISO 13485 and is entitled to affix the CE mark C 0197 notified Body TUV Rheinland LGA Products GmbH A Note If the device is used outside of the specifications proper func tion is no longer guaranteed We reserve the right to make tech 50 fold 5 2 x LR44 1 5V LED diodes 67 x 22 x 22 mm 39g 15 C to 30 C 10 70 50 106 kpa 0 to 70 C 10 95 50 106 kpa 1P22 effective against bigger solid bodies protected against dripping water nical changes to improve and further develop the product This device and its accessories comply with European stand ards EN60601 1 et seq and is subject to special safety meas ures in terms of electromagnetic tolerance 4 GB TECHNICAL DATA Electromagnetic compatibility The device complies with current specifications with regard to electromagnetic compatibility and is suitable for use in all premises including those designated for private residential purposes The radio frequency emissions of the device are ex tremely low and in all probability do not cause any interference with other devices in the proximity GENERAL INFORMATION A regular and stable menstrual cycle of a woman is about 28 days Approximately 14 days after the beginning of the last
8. e time of ovula tion Oestrogen can be detected in saliva as well as elsewhere in the body During a woman s fertile days the salt content in the saliva rises owing to the increased oestrogen production The salt crystals that form in dried saliva have a fern like structure This ferning pattern can be seen most clearly directly before ovulation During the infertile days this ferning pattern disappears owing to the increasing level of progesterone and a gravel like pattern is seen instead INFERTILE Conception is unlikely You see a gravel like pattern with dots and bub bles You are most probably not fertile TRANSITION PHASE LESS FERTILE Conception is possible but unlikely A few crystals with a slight ferning pattern are visible You are 3 4 days before ovulation This is the start of the fertile period FERTILE Conception is highly probable The ferning pattern is clearly visible Ovulation has begun Fertility lasts about 3 days During these fertile days sexual intercourse is recom mended if you wish to conceive 9 INTERPRETATION OF RESULTS Changes to the ferning pattern can be caused by the fol lowing After removal of contraceptives and other hormonal contra ceptive methods eg birth control pills After birth during and after lactation Eating drinking smoking brushing your teeth before testing EVALUATION CALENDAR Example for the month of January The
9. mone LH is one of the hormones that regulate reproduction Women have a steep rise of LH concentration in blood and urine which can be detected before ovulation which then again sub sides quickly Under the influence of estrogen LH is produced in greater quantities in the first half of the cycle When the oocyte is ma ture large amounts of LH are released into the blood by these ovulation is triggered GB 13 INDEX EXPLANATION OF TERMS Ferning Pattern The ferning pattern phenomena is occurring under the influ ence of estrogen very characteristic fern like formations of salt crystals in the dried saliva This phenomenon is particularly evi dent just before ovulation but disappears under the influence of progesterone in the second half of the menstrual cycle DISPOSAL Observe the applicable regulations when disposing of the device and batteries This product must not be disposed of together with domestic waste Please remove the batteries before disposing of the device unit Do not dispose of old batteries with your household waste but at a battery collection station at a x recycling site or in a shop WARRANTY The Geratherm ovu control is guaranteed against manu factur er s defect for one year from the date of purchase This guaran tee does not cover any damage to your product that is caused by improper handling The manufacturer is not responsible and cannot be held liable for improper use or the false
10. op the ovu control device and do not subject it to sudden impacts Protect it from dust dampness and heat Do not modify or disassemble the device Keep out of the reach of unsupervised children Consuma bles could be swallowed Damaged devices should not be used CHANGING THE BATTERIES First remove the blue casing You can change the batteries by pushing the white cover off by tipping it to the side Replace the empty batteries 2 X LR44 1 5V with new ones Pay attention to correct polarity the positive pole of both batter ies must be in the correct posi tion Push the white cover back onto the device 6 GB Step 1 Remove the long blue protective cap from the Geratherm ovu control Step 2 Carefully remove the lens by pulling it off the casing Carefully clean the outer smooth sur face of the glass with a dry dust free cloth Step 3 Preferably in the morning before eating breakfast cleaning your teeth or smoking place a drop of saliva on the middle of the lens using a clean and dry finger Dab the saliva onto the lens from above without smearing the drop Ensure that no air bubbles or foam are on the lens Leave the saliva sample to dry at room temperature for about 10 to 15 minutes To do this lay the lens aside with the drop uppermost A Note 1 Apply the Geratherm ovu control before eating drinking brushing teeth or smoking 2 In the early morning hours
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