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Geratherm pH-balance test for vaginal infections, 5 tests

Manufacturer: Geratherm
The Geratherm pH-balance test for vaginal infections is a vaginal self-test that can be performed by women with vaginal symptoms to help diagnose the cause of the infection.
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Product specifications
Specifier Value
Product Type Medical apliance, fast test
Place of use vagina
Purpose vagina hygiene
Advantage most ticklish and useful
Problem vaginal infection

Description

The Geratherm pH-balance test for vaginal infections is a vaginal self-test that can be performed by women with vaginal symptoms to help diagnose the cause of the infection.

• It reliably displays measured changes in pH.
• Easy to read color chart.
• Safe and easy to use thanks to a special applicator.
• 5 tests in a cover.
• For self-testing.

Vaginal infections are a common problem for women of all ages. The most common causes of vaginal infections are bacteria, yeasts and microorganisms trichomonas (possibly combinations of these microorganisms). How to use the test to self-diagnose vaginal disorders:

CONTENTS BOILERS

5 hygienically packaged test applicators for measuring vaginal pH values ??
Instructions for use
pH color scale (on the back of the test wrap)

< h4> USEFUL INFORMATION

Acidic vaginal pH from 3.8 to 4.4 is a basic prerequisite for the body's own vaginal immune system to function optimally. This can effectively prevent the colonization of pathogens and the development of vaginal infections. The most important and most natural protection against vaginal problems is therefore a healthy vaginal flora. There are many factors that regulate the composition and dynamics of the microbial vaginal ecosystem and maintain the natural protective function of the vagina. The central factor in this is lactobacilli (see Figure 1).
Under the influence of lactobacilli, glycogen, which is released from the cells of the upper wall of the vagina via sugar-glucose, is broken down all the way to lactic acid. This creates an acidic environment in the vagina with a pH value of normally 3.8 to 4.4. This acidic environment in the vagina provides effective protection against infections because the vast majority of disease-causing bacteria cannot thrive under such conditions. The physiological vaginal pH value thus depends on the sufficient presence of lactic acid.

The pH value in the vagina is subject to fluctuations.

Possible causes of changes in vaginal pH value are:
•   bacterial vaginosis
•   (atypical vaginal colonization)
•   mixed bacterial infections
•   sexually transmitted diseases
•   premature rupture
•   fruit wrap
•   estrogen deficiency
•   postoperative wound infections
•   excessive intimate care
•   antibiotic therapy

The rate is measured between & bdquo; acid " or & bdquo; basic " by determining the pH value (pH 1 to 14). Pure water has a pH of 7.0 and is thus neutral (neither acidic nor basic).

Physiological and thus normal vaginal pH (pH 3.8 to 4.4) is important for the body's own vaginal protective system and to maintain a healthy vaginal flora. Increasing vaginal pH to above 4.4
•   reduces the quality of life of affected women,
•   poses a significant health risk,
•   increases the risk of preterm birth.

Vaginal microecological imbalance (eg dysbiosis) is often associated with elevated pH  value. Vaginal pH values ??higher than 4.4 can lead to a greater number of gynecological problems and complications.

HEALTHY THROUGH PREGNANCY

At approx. 15 - 20% of all pregnant women are diagnosed with bacterial vaginosis (BV). 
This increases the risk of:
•   premature birth,
•   chorioamnionitis (infection of the fetal membranes and placenta),
•   early rupture of the fetal membrane,
•   fever during childbirth,
•   postpartum endometritis (inflammation of the uterine lining after childbirth),
•   bacterial infection of the fetus.

By regularly measuring their own vaginal pH, pregnant women can reduce their risk of infection. Measurement of vaginal pH is an integral part of the program for the prevention of premature births according to prof. E. Saling.

INTIMATE CARE WITH PH BALANCE

20 - 30% of all women in the gynecological clinic complain of inflammation of the vagina with various problems:
•   itching
•   burning sensation
•   dryness
•   increased discharge
•   unpleasant odor
•   Dysbiosis of the vaginal environment

One of the possible causes of such problems can be excessive or incorrect intimate hygiene (too often vaginal showering or incorrect hygiene products). With the help of pH-balance, health problems in a woman's intimate area are identified in a timely manner.

WHEN DOES USE MAKE SENSE?

•   in bacterial vaginosis (atypical settlement of bacteria in the vagina)
•   in the amount of dysbiosis
•   after anti-infective therapy (eg antibiotic treatment)
•   as part of preventive screenings
•   during pregnancy
•   with a known increased risk of preterm birth
•   after sexual contact with a new partner
•   when problems occur in the intimate area (burning sensation, itching, unpleasant odor, discharge)
•   before and after vaginal surgery

SMALL WORK - GREAT BENEFIT
Regular use of pH-balance reliably allows the detection of disturbed vaginal flora (eg dysbiosis).
We recommend that you take the measurement twice a week. This can also be used between preventive appointments for preventive gynecological examinations  make sure that the pH value of your vagina is appropriate You can also take measurements more often. This is recommended especially if you have had problems with vaginal infections during pregnancy or if you have even had a premature birth, as well as if you suffer more often from problems in the intimate areas as part of your intimate care, such as. itching, burning sensations, unpleasant odor or increased discharge.

TESTING PRINCIPLE
pH-balance is a reliable, painless hygienic method for determining vaginal pH. As soon as the pH measuring zone on the applicator comes into contact with the vaginal discharge, a color change occurs which can be compared to the value on the color scale. This value is the result of a test.

pH-balance is a registered medical device.

It is an approximately 8 cm vaginal applicator with a built-in pH measuring tape. The vaginal applicator consists of a round gripping zone and an approximately 5 cm long tube-shaped insert. At the tip of the insertion nozzle, there is an opening on one side, similar to a window, in which the indicator area of ??the pH bar is (pH measuring zone).
The round gripping zone serves to securely grip the vaginal applicator. The vaginal applicator is inserted approx. 1 to 3 cm deep into the vagina and  in doing so, the pH measuring zone is gently pushed towards the posterior vaginal wall. The pH measuring zone is moistened with vaginal secretions. The vaginal applicator is then removed from the vagina and the pH value is read.

TEST PERFORMANCE

The determination of the vaginal pH value is completely simple and completely painless. Relax and follow the steps below very carefully.

  1. Wash before starting the test hands.
  2. Open the cauldron, take out one test and open the foil.
    Hold the applicator only in the round grip zone.
  3. Hold the applicator in the grip zone between your thumb. and pointer as shown in the image  1. The thumb should always be on the side of the vaginal applicator where there is no pH measuring zone. If you use the vaginal applicator in this way, each test will be performed correctly.
  4. Prevent the pH measuring zone from coming into contact with other fluids.
  5. Place yourself in a sitting position with  with your knees apart, or place one foot on the seat of the side shell or some other solid surface.
  6. With your free hand, gently open the vaginal opening by gently opening the outer labia.
  7. >
  8. Push the vaginal applicator gently into the vagina, similar to using a tampon
    (see Figure 2; about 1 to 3 cm deep - but not deeper than to the round grip zone). Inserting the vaginal applicator is completely painless.
  9. Now press the inserted applicator with gentle pressure for about 10 seconds against the back wall of the vagina (in the direction of the anus) to moisten the pH measuring zone well. Sufficient hydration is very important for test analysis.
  10. Then carefully remove the vaginal applicator from the vagina.

READING AND EVALUATION OF THE TEST RESULT

Immediately after withdrawal of the vaginal applicator, read the result from the vagina while the measuring zone is still moist. Compare the color of the pH of the measuring zone with the color scale and write down the value that looks most similar to the measured pH value. After analysis, dispose of the used applicator in normal household waste.

IMPORTANT: If the pH measuring zone does not show a uniform color after the test, it means that the test was not performed correctly . A possible reason for this is that the pH measuring zone was not sufficiently moistened with vaginal secretions. In this case, the measurement can be repeated with the same vaginal applicator. However, you can also use a new test.

Use only the enclosed color scale to analyze the test!
Normal range: Vaginal pH values ??  in the range between 4.0 and 4.4 they lie in the normal / healthy range. The color of the indicator is yellowish.

Vaginal pH values ??above 4.4 lie outside  normal / healthy area. The color of the indicator is darker and changes to a brown-green color tone.

WHAT TO DO IF THE PH VALUE IS NOT IN THE NORMAL RANGE?

If your pH value is not in the in the normal range, this is not a cause for concern. In this case, please repeat the measurement a few hours later or the next day.

In the event that the pH is then not within the normal range, discuss the test result with your doctor to the cause of the increased pH value was discovered. Please keep in mind that a number of factors can temporarily alter vaginal pH without affecting any disease (see also & bdquo; Important Notes ").

In the following symptoms and in case the vaginal pH value does not fall within the normal range again, you should always consult a doctor:

  • bleeding, including oily bleeding
  • suspected amniotic fluid leakage
  • menstrual-like problems
  • fever
  • burning sensations when urinating
  • itching or burning sensation in the vagina
  • increased discharge
  • unpleasant odor reminiscent of fish odor

PERFORMANCE INFORMATION < / h4>

Measuring range: The measuring range of the Geratherm pH-Balance ranges from 4.0 to 7.0. 
Diagnostic sensitivity and specificity: Buffer solutions and measurements against the pH meter were used to detect diagnostic sensitivity and specificity. Sensitivity was 100%, specificity 86.4%.

Proof of performance: The study on users was performed in two parts.
In the first part with 56 participants, only the pH of the two blank samples was determined. In the second part with 20 participants, in addition to the blank samples, the own vaginal pH value was also determined. The objectives of the study were to check the comprehensibility of the instructions for use, the difficulty of feasibility and ease of use of the test and to check whether a non-professional can determine the pH values ??semiquantitatively.
The result showed that the exact pH value of the blank samples was recognized in 96 or 97%. Deviations from the absolute pH value were usually one degree higher or lower. 
The pH range was correctly detected in all cases.

Cross-reactions: Drugs, bilirubin and albumin, and other metabolites were used as possible interferences. The cross-reaction was demonstrated with hemoglobin.

IMPORTANT NOTES

  • Use each applicator only once.
  • < li> Use only as intended, do not ingest.
  • The applicator only determines the pH value and does not detect infection.
  • Acidic pH cannot 100% prevent infections. If you experience problems despite your normal pH, contact your doctor.
  • Do not use the test after the expiration date (see date on the & caron; cauldron).
  • Certain events may occur. they temporarily change the pH of the vagina and lead to erroneous results. Therefore, please observe the following restrictions when performing the test / measurement:
    • Do not perform the measurement before 12 hours after sexual intercourse,
    • Do not perform the measurement before 12 hours after sexual intercourse after using vaginal therapeutic agents (vaginal suppositories, cream, gel, etc.),
    • perform the measurement only 3-4 days after the end of menstruation (periods), if you use the test outside of pregnancy,
      o   Do not take the measurement before 15 minutes after urination, as urine residues could affect the test result.
  • Do not shower or wash the intimate area immediately before the measurement.
  • Never start any therapy before discussing the test result with your doctor.
  • Unprofessional use of the test applicator can lead to defloration in innocent women (rupture of the hymen = hymen). , similar to using a tampon.

STORAGE

Keep the test in a closed protective bag at room temperature and out of reach of children.

Additional description

PRINCIP TESTIRANJA
pH-balance je zanesljiva, higienska metoda brez bolečin za določanje vaginalne pH vrednosti. Takoj ko pH merilna cona na aplikatorju pride v stik z vaginalnim izločkom, nastane barvna sprememba, ki se lahko primerja z vrednostjo na barvni lestvici. Ta vrednost je rezultat testa.

pH-balance je registriran medicinski pripomoček.

Gre za približno 8 cm velik vaginalni aplikator z vgrajenim merilnim trakom za pH. Vaginalni aplikator sestavljata okrogla cona za prijemanje in približno 5 cm dolg nastavek za vlaganje v obliki tubusa. Na konici nastavka za vlaganje se na eni strani nahaja odprtina, podobna oknu, v kateri je indikatorska površina pH paličice (pH merilna cona).
Okrogla cona za prijemanje služi za varno prijemanje vaginalnega aplikatorja. Vaginalni aplikator se vloži pribl. 1 do 3 cm globoko v nožnico in pri tem se pH merilna cona blago potisne proti zadnji vaginalni steni. Pri tem se pH merilna cona navlaži z vaginalnim izločkom. Zatem se vaginalni aplikator izvleče iz nožnice in se odčita pH vrednost.

ODČITAVANJE IN OCENA TESTNEGA REZULTATA

Takoj po umiku vaginalnega aplikatorja iz nožnice odčitajte rezultat, dokler je merilna cona še vlažna. Primerjajte barvo pH merilne cone z barvno lestvico in si zapišite vrednost, ki izgleda najbolj podobna izmerjeni pH vrednosti. Po analizi uporabljeni aplikator odložite v normalne gospodinjske odpadke.

POMEMBNO: V primeru, da pH merilna cona po izvedbi testa ne prikazuje enotne barve, pomeni, da test ni bil opravljen pravilno. Možen vzrok za to je, da pH merilna cona ni bila zadostno navlažena z vaginalnim izločkom. V tem primeru lahko meritev ponovite z istim vaginalnim aplikatorjem. Lahko pa uporabite tudi nov test.

Za analizo testa uporabite samo priloženo barvno lestvico!
Normalno področje: Vaginalne pH vrednosti v območju med 4,0 in 4,4 ležijo v normalnem/ zdravem področju. Barva indikatorja je rumenkasta.

Vaginalne pH vrednosti iznad 4,4 ležijo izven normalnega/zdravega področja. Barva indikatorja je temnejša in prehaja v rjavo-zeleni barvni ton.

KAJ STORITI, ČE PH VREDNOST NE LEŽI V OBMOČJU NORMALNEGA?

Če Vaša pH vrednost ne leži v območju normalnega, to še ni razlog za skrbi. V tem primeru prosimo, da nekaj ur pozneje ali naslednji dan ponovite meritev.

V primeru, da pH vrednost potem še ne bi bila v območju normalnega, se o rezultatu testa pogovorite s svojim zdravnikom, da bi se odkril vzrok povišane pH vrednosti. Prosimo, mislite na to, da lahko veliko število dejavnikov začasno spremeni vaginalno pH vrednost, ne da bi pri tem šlo za neko bolezen (glej tudi „Pomembni napotki").

Pri naslednjih simptomih in v primeru, da vaginalna pH vrednost ponovno ne leži v območju normalnega, bi se morali vedno posvetovati z zdravnikom:

  • krvavitve, tudi mazne krvavitve
  • sum na puščanje plodovnice
  • težave, podobne menstruaciji
  • vročina
  • pekoči občutki pri uriniranju
  • srbenje ali pekoč občutek v nožnici
  • povečan izcedek
  • neprijeten vonj, ki spominja na vonj po ribah

ZMOGLJIVOSTNI PODATKI

Merilno področje: Merilno območje naprave Geratherm pH-Balance obsega pH vrednosti od 4,0 do 7,0.
Diagnostična občutljivost in specifičnost: Za detekcijo diagnostične občutljivosti in specifičnosti so bile uporabljene puferne raztopine in meritve v primerjavi s pH-metrom. Občutljivost je znašala 100%, specifičnost 86,4%.

Dokazilo delovanja: študija na uporabnicah je bila opravljena v dveh delih.
V prvem delu s 56 udeleženkami je bil določena samo pH vrednost dveh slepih vzorcev. V drugem delu z 20 udeleženkami je bila razen slepih vzorcev določena tudi lastna vaginalna pH vrednost. Cilji študije so bili preverjanje razumljivosti navodila za uporabo, težavnost izvedljivosti ter lahke uporabnosti testa in preverjanje, ali nestrokovna oseba lahko semikvantitativno določati pH vrednosti.
Rezultat je pokazal, da je bila natančna pH vrednost slepih vzorcev prepoznan v 96 oziroma 97 %. Odstopanja od absolutne pH vrednosti so ležala praviloma za eno stopnjo višje ali nižje.
pH območje je bilo v vseh primerih pravilno zaznano.

Navzkrižne reakcije: Kot možne interference so bila uporabljena zdravila, bilirubin in albumin ter drugi metaboliti. Navzkrižna reakcija se je pokazala s hemoglobinom.

POMEMBNI NAPOTKI

  • Vsak aplikator uporabite samo enkrat.
  • Uporabljajte samo v skladu z namembnostjo, ne zaužijte.
  • Z aplikatorjem se določa samo pH vrednost, ne dokazuje pa se okužba.
  • Kisla pH vrednost ne more 100%-no preprečiti okužbe. V primeru, da kljub normalni pH vrednosti začutite težave, se obrnite na svojega zdravnika.
  • Testa ne uporabljajte po poteku datuma uporabnosti (glej datum na škatlici).
  • Določeni dogodki lahko začasno spremenijo pH vrednost nožnice in vodijo do napačnih rezultatov. Zato prosimo, da pri opravljanju testa/meritvi upoštevate naslednje omejitve:
    • meritve ne opravljajte pred potekom 12 ur po spolnem odnosu,
    • meritve ne opravljajte pred potekom 12 ur po uporabi vaginalnih terapevtskih sredstev (vaginalne svečke, krema, gel itd.),
    • meritev opravljajte šele 3 - 4 dni po koncu menstruacije (periode), če test uporabljate izven nosečnosti,
      o meritve ne opravljajte pred potekom 15 minut po uriniranju, ker bi ostanki urina lahko vplivali na rezultat testa.
  • Ne prhajte in ne umivajte intimnega področja neposredno pred merjenjem.
  • Nikoli ne začenjajte neke terapije, preden se o rezultatu testa ne pogovorite s svojim zdravnikom.
  • Pri nestrokovni uporabi testnega aplikatorja lahko pri nedolžnih ženskah pride do defloracije (raztrganje himena = deviške kožice), podobno kot pri uporabi tampona.

SKLADIšČENJE

Test hranite v zaprti zaščitni vrečici pri sobni temperature in izven dosega otrok.

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