INTENDED USE The StrongStep^® Bacterial vaginosis(BV) Rapid Test Device is intend to measure the vaginal pH for aid in the diagnosis of Bacterial vaginosis. INTRODUCTION An acidic vaginal pH value of 3.8 to 4.5 is a basic requirement for the optimal functioning of the body’s own system of protecting the vagina. This system can effectively avoid colonization by pathogens and the occurrence of vaginal infections. The most important and most natural protection against vaginal problems is therefore a healthy vaginal flora. The pH level in vagina is subject to fluctuations.Possible causes of an alteration in the vaginal pH level are: ■ Bacterial vaginosis (abnormal bacterial colonization of the vagina) ■ Bacterial mixed infections ■ Sexually transmitted diseases ■ Premature rupture of fetal membranes ■ Estrogen deficiency ■ Postoperative infected wounds ■ Excessive intimate care ■ Treatment with antibiotics PRINCIPLE The StrongStep^® BV Rapid Test is a reliable, hygienic, pain-free method of determining the vaginal pH level. As soon as the convex pH measurement zone on the applicator comes into contact with vaginal secretion, a color change occurs that can be assigned to a value on the color scale. This value is the test result. The vaginal applicator consists of a round handle area and an insertion tube of approx. 2 inch in length. On one side at the tip of the insertion tube is a window, where the indicator area of the pH strip is located (pH measurement zone).  The round handle makes it safe to touch the vaginal applicators. The vaginal applicator is inserted approx. one inch into the vagina and the pH measurement zone is pressed gently against the back wall of the vagina. This moistens the pH measurement zone with vaginal secretion. The vaginal applicator is then removed from the vagina and the pH level is read. KIT COMPONENTS 20 Individually packed test devices 1 Instructions for use PRECAUTIONS ■ Use each test only once ■ Use only for intended purpose, not for consumption ■ The test determines only the pH value and not the presence of any infection. ■ An acidic pH value is not 100% protection against infections. If you notice symptoms despite a normal pH value, contact your doctor. ■ Do not perform the test after the expiration date (see date on packaging) ■ Certain occurrences may alter the vaginal pH value temporarily and lead to false results. You should therefore take into account the following time limits before performing the test / taking a measurement: - Measure at least 12 hours after sexual activity - Measure at least 12 hours after the use of vaginal medical products (vaginal suppositories, creams, gels, etc.) - Measure only 3-4 days after the end of a period if you are using the test when not pregnant - measure at least 15 minutes after urination because remaining urine can lead to false test results ■ Do not wash or shower the area immediately before taking the measurement ■Be aware that urine may cause a false test result ■ Never begin any treatment before you have discussed the result of the test with a doctor ■ If the test applicator is not used properly, this may lead to a tearing of the hymen in women who are not yet sexually active. This is similar to the use of a tamponBacterial vaginosis 1Bacterial vaginosis 2InstructionsVaginal pH as a marker