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Amni Sense

 
 
 
   
   
   
 
 


 
   
     
 
 

The Amniotic Leak  Detection Kit

   
  The AMNI SENSE detector is an in vitro self-test, easy-to-use home test kit that allows you to detect probable leakage of amniotic fluid whenever your physician suspects you may be in a higher risk than normal of amniotic fluid leak. Risk of amniotic fluid leak are higher than normal during 48 hours after amniocentesis tests, or when encountering unidentified wetness, or among women with history of premature membrane rapture.
   
   
 

Mode Of Action :

   
  The AMNI SENSE changes colors when it comes in contact with fluid of pH level greater than 5. Amniotic fluid pH levels are greater than 6.5.
   
   
  Indications for Use
   
 

This product is intended to detect leaking amniotic fluid and identify cause of wetness during pregnancy.

   
   
  Limitation of the device
   
  Antibiotic therapy or vaginal infections (such as bacterial vaginosis or Trichomoniasis) can lead to an elevated vaginal pH level, which may result in a false-positive test result for the presence of amniotic fluid. The possibility of a vaginal infection may be evaluated using standard diagnostic procedures.
   
   
  Package Contents:
   
  The AMNI SENSE Kit contains 2 test panty liners, 2 plastic drying boxes, and instructions for use in multilanguages. Keep the TPL sealed and use it immediately after opening Time watch is not supplied, the user will use her own watch to measure the wearing time and the drying time.
   
   
  Conditions for Use :
 

To ensure valid results, do not use the AMNI SENSE monitoring device if the answer to any of the following questions is YES: (1) is it less than 12 hours after sexual intercourse? (2) is it less than 12 hours after vaginal douching? During bleeding results reading may need professional assistance.

Report all bleeding situations to your physician. In case of sensitization or irritation of skin, at the application site, stop use and contact your physician.
   
 

Directions for Use

 
  1. Tap water can interfere with the test — wash and dry your hands.
  2. Unwrap the Test Panty Liner (TPL). The TPL contains a removable pale yellow indicator strip.
  3. Attach the TPL to your underwear (Figure 1). The pale yellow indicator strip should sit directly against your vagina. Wear the TPL as you would a normal panty liner till you feel wetness (donot exceed 12 hours).
  4. When the TPL is wet or when you replace the TPL, prepare the enclosed plastic box.
  5. Remove the indicator strip from the TPL by gently pulling the loose tail of the indicator strip .
  6. Lay the indicator strip on the white cloth in the open plastic box  Close the box. Dispose of the TPL.
  7. If you feel wetness and the indicator strip is completely yellow, consider using another test. If the indicator strip is stained blue or green, wait 30 minutes and check the color of the indicator strip.
   
 
   
  Reading your Results:
   
  After 30 minuets of drying, look at the color of the indicator strip. If the indicator strip stained blue or green, the fluid leak is probably amniotic fluid. Consult your physician or go to the hospital without delay.
   
  If the indicator strip stained blue or green but the color faded back to yellow during the 30 minute waiting period, the indicator strip has been in contact with urine. If you feel wetness and the indicator strip did not change color, consider using another TPL or report the situation to your physician.
   
   
  Showing the Indicator Strip to your Physician :
   
  Positive results should be reported to the physician. Some physicians may request to observe the results (the stained strip). The color change in cases of amniotic fluid leak is stable for more than 2 hours. If you intend to show the indicating result to your physician, bring the closed plastic box containing the indicator strip to your physician within 2 hours.
   
  Storage :
   
  Store in a dry place at room temperature. Keep the TPL sealed until use to avoid contamination. Please note the expiration date stated on the TPL. If in doubt, consult with the dispensing pharmacist.
  Keep out of reach of children.
   
  Presentation:
   
  The AMNI SENSE Kit contains 2 test panty liners, 2 plastic drying boxes
   
  Ace-Amni Sense-Packshot
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
   
 
         
 
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