Silicon Inflatable Donut Pessary
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Silicone Inflatable Donut Pessaty Visit our website: www.bioteque. com Tel 1-800-889-9008 Fax 1-408-526-9399 Panpac Medical Corporation 6F-2, NO. 202, Sec. 3, Ta-Tong Road, Shi-Chih District, New Taipei City, manufacturer Taiwan DEVICE DESCRIPTION Inflatable Donut Pessary is for single-patient use silicone pessary for mild cystocele and/or rectocele associated with procidentia/prolapse. There are four different sizes available shown below. It is necessary to have available a minimum of two sizes. IMPORTANT DO NOT OVER INFLATE. See suggested number of squeezes. Overinflation will weaken silicone. If your pessary “balloon” out, it is an indication that it has been overinflated and you need a large size Inflatable Donut Pessary. FITTING INSTRUCTIONS FOR THE PHYSICIAN 1. Inflatable Donut Pessary is fitted by trial and error. There are no mechanical devices available that can accurately determine the size your patient requires to obtain the desired results. 2. Fitting diaphragms should not be used to measure the size pessary a patient need. 3. Even before fitting a pessary, the patient should be informed that it is not uncommon to have to change the size more than once after being originally fitted. This is why it is so important that your patient be instructed to return within 24 hours of the initial fitting and again in 72 hours. Thereafter, re-examination every few months is recommended to ensure a proper fit is maintained as long as the patient is wearing the pessary. 4. At each visit the pessary should be removed and the vaginal vault inspected for signs of allergic reaction or undue pressure. 5. At the physician's discretion, the patient can be instructed in the proper removal, cleaning and reinsertion techniques for her own pessary. This process can be performed nightly by patient under ideal condition. 6. A noncomplian patient should not be fitted with Inflatable Donut Pessary. It is essential that your patient understands the importance of these frequent follow-up visits and that she fully cooperates with you to ensure the desired results. Note: (1) Experience has shown that in order to properly fit an Inflatable Donut Pessary, you should have at least one of two most commonly used sizes of this pessary (sizes 57 (ID3) and 64 (ID4)). (2) The physician can suggest K-Y® jelly, Replens® , Replens, if you need to use lubricant. INDICATIONS The Inflatable Donut Pessary is effective support in second- or third-degree prolapsed, and also effective in patients with mild cystocele or rectocele associated with a procidentia/prolapsed. Support of Inflatable Donut Pessary can be adjusted based on the its inflation level. CONTRAINDICATIONS 1. Do not use during pregnancy because of the risk of air embolism. 2. Inflatable Donut Pessary is contraindicated in acute genital tract infections, pelvic infections, endometriosis, or non-compliant patients. 3. Sexual intercourse is contraindicated with Inflatable Donut Pessary in place. CAUTIONS 1. Federal law restricts this device to be sold by or on the order of a physician. 2. The device is for single patient use only. Do not share your device with others. PESSARY CARE DO NOT AUTOCLAVE OR BOIL. Prior to initial use, the Inflatable Donut Pessary must be washed with a mild soap and the pessary thoroughly rinsed with water and dried. Note: 1. The Inflatable Donut Pessary should be periodically checked for deep cracks or discoloration that make adequate cleaning impossible.

2. Do not immerse air pump of Inflatable Donut Pessary in water or any solutions to avoid malfunction. stem into the vaginal vault. 5. Once in place, have the patient sit, stand and bear down. Examine the patient while she is in the standing position to ensure the pessary has not shifted position. The pessary should not be too loose as it may turn or be expelled, and it should not be too tight as it may cause discomfort. I t i s s om et i m es n ec es s a r y t o ref i t t he p at i e nt wi t h a d i ff e r ent s i z e af t er a p er i o d of t i m e. Ch ec k t he f i t t i ng t o e ns u r...