Frequently Asked Questions

Orders may be placed by fax, phone, email, regular mail, or online. Please be sure to include the product catalog number, product description, price, and quantity. Please visit our Ordering Information page for further details.

Please refer to TERMS AND CONDITIONS OF SALE (FEMA T&C) and (JCEC T&C).

Dilapan is manufactured in the Czech Republic by GelMed International in a small rural town west of Prague, the Czech capital. The facility is ISO 13485 certified, cGMP compliant, and registered with the FDA.

Our other products are manufactured in Mirandola, Italy by Ri. Mos. Srl. The company is able to design and manufacture custom-made products upon customer request. Thanks to a modern production technology, RI.MOS products are assembled by trained operators in ISO 7 and ISO 8 clean rooms. RI.MOS quality system is ISO13485 standard certified. Product certifications currently obtained are: CE mark, FDA cleared (USA), GOST (Russia), ANVISA (Brazil).

Our in vitro diagnostic tests are manufactured in the United States by ALFA Scientific Designs of San Diego California. Alfa Scientific Designs, Inc. is a California-licensed, cGMP compliant, and ISO13485 registered manufacturer of in-vitro diagnostic devices. Founded in 1996, ALFA leads the industry in developing and manufacturing high quality rapid in-vitro diagnostic devices.

We are happy to provide a limited number of free product samples for some of our products to customers. Please contact our Sales Department at info@dilapan.com with your request.

If you are interested in becoming an exclusive distributor in your area, we would be happy to review your marketing proposal, as well as your company history to determine options for exclusivity.

If you are interested in custom designed pouches, labels, and kits to meet your specific needs, we would be happy to discuss your needs.

We are happy to offer in-house product development services as well as custom product configurations. Please contact our Sales Department at info@dilapan.com with details of your request.

Our goal is complete customer satisfaction, and we will address all customer concerns promptly. If you are not satisfied with the products purchased, return it to us within 30 days for an exchange or a refund of the purchase price of the product. Any claims about forwarding, delivery, quantity, and quality of the goods must be made within five (5) days from the delivery date of the goods. FEMA International and J.C.E.C accepts any claim for shortage or damages of the goods only if together with a copy of the delivery note, where the concern/reservations expressed to the carrier at the moment of receiving the goods will be written. Any return of goods MUST be authorized by FEMA International or J.C.E.C. Returned goods must be made in the original packaging and cartons have to be properly sealed. All shipping charges from buyer’s facility to the J.C.E.C facility are the responsibility of the buyer, unless otherwise agreed between the parties.

Breakage has been associated with Dilapan-S. Breakage of Dilapan-S while in situ is covered in detail in SECTION III, item #4 in the INSTRUCTIONS FOR USE. Please follow these instructions. Report all incidences of breakage in writing to FEMA International, email: info@dilapan.com.

User of Dilapan-S in the United States are asked to report all adverse events, potential and actual product errors, and product quality problems associated with the use of Dilapan-S to JCEC Company, email: info@dilapan.com and the FDA, see: http://www.fda.gov/medwatch/index.html

The handle may come off the dilator, although, this has not been reported during clinical use of the product. If the handle does come off the dilator while attempting to remove the dilator from the uterus please refer to SECTION III, ITEM #4, in the INSTUCTIONS FOR USE. Report all incidences of breakage in writing to FEMA International, email: info@dilapan.com.

Users of Dilapan-S in the United States are asked to report all adverse events, potential and actual product errors, and product quality problems associated with the use of Dilapan-S to JCEC Company, email: info@dilapan.com and the FDA, see: http://www.fda.gov/medwatch/index.html.

SECTION III, ITEM #3 of the INSTRUCTIONS FOR USE discusses entrapment and the steps that should be taken if the device appears to be stuck in the cervical canal. Allowing time to elapse (5 minutes) before re-attempting removal has anecdotally been found to be of benefit, the reason is unclear. No attempt should be made to twist or pull on the marker string of the device within 30 minutes after insertion.

If you have a problem with Dilapan-S you shall report each such incident to FEMA International in writing indicating the device specification and lot number through one of the following:

Email: info@dilapan.com
Register your problem with us, see "Contact Us"

Users of Dilapan-S in the United States are asked to report all adverse events, potential and actual product errors, and product quality problems associated with the use of Dilapan-S to JCEC Company, email: info@dilapan.com and the FDA, see: http://www.fda.gov/medwatch/index.html.
 

In clinical trials Dilapan-S has been shown to dilate the cervix gradually. The amount of dilation achieved depends upon the amount of time in situ. The amount of time that the device is left in situ will be dictated by a number of factors including approved indication for use (this device is limited to four hours in the United States; elsewhere the device may be used up to the discretion of the health care provider); gestational age, clinician experience. SECTION II of the INSTRUCTIONS FOR USE provides some guidelines. 

We recommend that the Dilapan-S be pre-moistened prior to insertion. This is accomplished with sterile water or betadine solution. Pre-moistening the Dilapan-S will initiate the hygroscopic action of the device and increase the lubricity easing insertion. Insertion is not unduly uncomfortable; some period type cramping may be experienced.

The number of Dilapan-S devices inserted depends upon the amount of dilation required. This is further indicated by a number of factors including approved indication for use (this device is limited to one device in the United States; elsewhere the number of devices used is at the discretion of the health care provider); gestational age, clinician experience. SECTION II of the INSTRUCTIONS FOR USE provides some guidelines.

Clinical research using the Dilapan-S has shown that it is safe and effective when used in accordance with the INSTRUCTIONS FOR USE. The INSTRUCTIONS FOR USE provide a general guideline that can be followed based upon the intended use of the device, but should not replace good clinical information and experience.

Samples of the Dilapan-S are generally not available. Dilapan-S is available in three sizes and in boxes of 25 individually wrapped devices. The three sizes are: 4mm x 65mm, 4mm x 55mm, and 3mm x 55mm.

However, Dilapan-S does come with a money back guarantee. Should you purchase Dilapan-S and for whatever reasons are unhappy with the performance of the product within 30 days of purchase, your money will be completely refunded.
 

Dilapan-S can be ordered through FEMA International and JCEC Company (United States and Canada). Please refer to "Placing an Order."

Each Dilapan-S device is sterilized using irradiation of a predetermined dose. The sterilization process has been validated effective in sterilizing the device and is closely monitored on an ongoing basis by the manufacturer. Irradiation sterilization does not pose any threat of residuals or degradation of the device. Each device is sterile within the single pouch packaging. Once the pouch is opened the device should be used.

Dilapan-S is a single use device and MUST be discarded following use. The device should not be autoclaved or re-sterilized in any fashion. DO NOT ATTEMPT TO RE-USE THIS DEVICE.

Clinical research using the Dilapan-S device has shown that it is safe and effective when used in accordance with the INSTRUCTIONS FOR USE. Careful placement of the device is essential to avoid traumatic injury to the cervix or uterus and to avoid migration of the device either upward into the uterus or downward into the vagina.

Dilapan-S is made from a polymer called AQUACRYL, a proprietary hydrogel. The dilator is a firm hygroscopic rod similar in shape to natural laminaria tents. Dilapan-S is capable of increasing in diameter on average from three (3) millimeters to 8.4 – 10mm; or, four (4) millimeters to 10 – 12.5 mm within 4-6 hours by absorbing moisture from the genital tract. 

The materials have been extensively tested chemically to determine if any products leached from the Dilapan-S during rehydration. All tests results have been favorable and indicate that no products are leached from the Dilapan-S device during dehydration that would make the device unsafe.

Dilapan-S has a shelf-life of three years from the date of sterilization. This means that under controlled room conditions the Dilapan-S device can be stored up to three years. The expiration date of each device is printed on the individual unit pouch and the dispenser box.

Dilapan-S is made from a man made material that is manufactured in a state of the art manufacturing facility that is designed to provide a medical device that consistently provides safe and effective cervical dilation. The manufacturing steps and technology employed are such that your satisfaction is guaranteed and the advancement of women’s healthcare ensured.

Cassette test: 25 tests/kit and one (1) instruction sheet
Dip Strip test: 50 tests/kit and one (1) instruction sheet
Multi-panel test (2-6 panel): 25 tests/kit and one (1) instruction sheet

The kit, including the test strips, cassette or multi-panel devices, can be stored at room temperature 15-30°C (59-86°F) until the printed expiration date on the label if it remains sealed in its pouch containing desiccant.

The urine specimens may be kept at room temperature, 15-30°C (59-86°F), for 8 hours, at 2-8°C for up to 3 days and at -20°C or lower for prolonged storage.

Samples may be diluted by either adding a fluid to the sample after collection or by drinking excess amounts of fluids before taking the drug test.

Another form of tampering is substitution. Samples can be substituted with non-urine substances such as apple juice, lemonade, beer, or water. Also, samples can be substituted with another person’s urine and be brought into the collection site by taping a bag of urine to their leg or by using a pump.

Having a controlled sample collection environment and procedure can help minimize tampered samples. Diluted or substituted samples can have abnormal temperatures; therefore, we offer a sample collection cup with a temperature strip to ensure the sample is the correct temperature before the test is performed. Make sure temperatures are taken within 4 minutes of sample collection. In addition, donors can be required to wash their hands prior to providing the sample and/or provide their sample in a bathroom with limited water supply.

When performing the dipping method, make sure to dip the test strip or multi-panel device into the specimen for at least 10 seconds. Make sure to keep the specimen below the level indicated by the arrows on the test strips. For multi-panel devices, keep the specimen level below the level indicated by the arrows on the test strip, but above the sample well on the device.

The Instant-View® 2-6 multi-panel devices have the option to be used as either as a dip and read device or with the transfer pipette method. When using the pipette method, a full dropper (or 12 drops) of specimen should be used to insure sufficient sample size.

The Instant-View tests have a built-in control line to show the test is working properly. If the Control (C) line does not appear, repeat the test with a new device. External controls may be used according to local laboratory guidelines.

Read the test results between four (4) to seven (7) minutes after adding the specimen. The results should not be read after seven (7) minutes.

Positive: The absence of the Test (T) line indicates a positive result

Negative: If the C line and the T line both appear, the result indicates that the level for the corresponding drug or its metabolite is below the cut-off level. Please note, a very faint line in the test region (T line) should be considered negative.

Invalid: If no C line develops within five (5) minutes, the test is invalid. In this case, repeat the test with a new testing device.

The absence of a line in the test region (T line) indicates a presumptive positive result. Samples with positive results should be confirmed with a more specific method before a positive determination is made.

The Instant-View® tests provide only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is one of the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.