MEDLINE MDS6301600 Series Ring Pessary Instruction Manual

MEDLINE MDS6301600 Series Ring Pessary

Product Information: Pessary

A pessary is a flexible silicone device that is commonly used for uterine prolapse, procidentia, or incontinence. It is available in various shapes such as cube, ring, gellhorn, oval, with/without drainage donut, with/without support gehrung, short and long stem dish, with/without support ring (with knob), shaatz, hodge,  with/without support cup, with/without support marland, and incontinence ring with/without support. The pessaries are designed for single patient use and are supplied non-sterile. It is important to note that U.S. Federal law restricts the sale of this device to be done only by or on the order of a physician.

Indications for Use
The flexible silicone pessary is commonly used for uterine prolapse, procidentia or incontinence.

Contraindications
There are no specific contraindications for the usage of pessaries. However, it is recommended to consult a physician before using the device.

Warnings
The pessary styles containing metal components should not be used during x-ray, ultrasound and MRI procedures. The incontinence ring, Hodge and Gehrung pessaries contain metal and must be removed prior to MRI, ultrasound and x-ray procedures.

Precautions
It is recommended to consult a physician before using the device. A vaginal lubricant may be required for the patient’s comfort before insertion of a pessary.

Instructions for Use

The fitting of the pessary usually requires a trial of various sizes to determine the proper pessary size. A Pessary Fitting Set is a valuable aid in selecting the correct pessary.

Before the fitting and introduction, perform a normal pelvic examination. The patient may require a vaginal lubricant for  comfort before insertion of the pessary. Tell the patient to report any discomfort immediately.

Removal, Cleaning and Suggested Follow-up

1. To remove the pessary, carefully move the pessary forward toward the introitus. When the pessary is within reach, compress the pessary and carefully withdraw.
2. The pessary should be removed for cleaning every day or two. The pessary can be cleaned with mild soap and warm water.
3. Advise the patient on pessary usage during sexual activity.
4. Discuss the importance of following instructions and the expected length of time for pessary use.
5. Within 24 to 48 hours, be sure the patient is not allergic to the pessary. Examine the vagina and ask the patient if there has  any discomfort, irritation, pressure, sensitivity, or unusual vaginal discharge. Also determine if there has been any improvement in her personal symptoms.
6. Schedule follow-up visits to fit the needs of the patient.

The pessary is not made with natural rubber latex.

Note that this device is non-sterile and is for single patient use only.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See Warnings and Precautions. Consult Instructions for Use.

Important: Non compatible with MRI.

INDICATIONS FOR USE

The flexible silicone pessary is commonly used for uterine prolapse, procidentia or incontinence. Pessaries are designed for single patient use and supplied non-sterile.
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.

CONTRAINDICATIONS

Pessaries are contraindicated in:

• Acute genital tract infections
• Pelvic infections
• Noncompliant patients.

WARNINGS:

• Do not leave pessaries in place for longer than intended use, as serious complications can occur which may require surgical intervention.
• Do not use these pessaries on a patient with a known silicone allergy.
• Incontinence ring, gehrung and Hodge Pessaries must be removed prior to x-ray, ultrasound and MRI procedures as these pessary styles contain metal components.

PRECAUTIONS:

• Physicians must consider a patient as being under their active care as long as the patient wears a pessary.
• If the patient is not able to remove the pessary on their own for cleaning and inspection, more frequent office visits are required.

INSTRUCTIONS

Fitting usually requires a trial of various sizes to determine the proper pessary size. Pessary Fitting Set is a valuable aid in selecting the correct pessary. A vaginal lubricant may be required for the patient’s comfort before insertion of a pessary.

1. Perform a normal pelvic examination prior to the fitting and introduction of a pessary. A pelvic exam helps determine the appropriate size. The pessary will easily fold across the largest drainage holes to simplify insertion and removal. The pessary should be large enough for its indication, yet not cause any undue pressure or discomfort.
2. Compress the pessary and gently insert the pessary through the introitus. Once the pessary has passed the introitus, release the compressed pessary so that it expands to its normal shape.
3. Gently move the pessary to the cervix to support the cystocele or rectocele and the uterus. When in the correct position, the physician should be able to insert an examining finger between the outer edge of the pessary and the vaginal wall. This spacing will insure the patient’s comfort and reduce the risk of pressure necrosis.
4. Once in place, the pessary should not dislodge when standing, sitting, squatting or bearing down. It should not be uncomfortable for the patient during any of these routine activities.
5. When fitting a pessary, be sure to instruct the patient on its cleaning, insertion and removal. The patient should perform these tasks before the first follow-up visit.
6. Tell the patient to report any discomfort immediately.

REMOVAL, CLEANING AND SUGGESTED FOLLOW-UP

1. To remove the pessary, carefully move the pessary forward toward the introitus. When the pessary is within reach, compress the pessary and carefully withdraw.

2. The pessary should be removed for cleaning every day or two.
   The pessary can be cleaned with mild soap and warm water.

3. Advise the patient on pessary usage during sexual activity.

4. Discuss the importance of following instructions and the expected length of time for pessary use.

5. Within 24 to 48 hours, be sure the patient is not allergic to the pessary. Examine the vagina and ask the patient if there has been any discomfort, irritation, pressure, sensitivity, or unusual vaginal discharge. Also determine if there has been any improvement in her personal symptoms.

6. Schedule follow-up visits to fit the needs of the patient.

MRI unsafe
Incontinence Rin, Hodge and Gehrung pessaries contain metal and must be removed prior to MRI, ultrasound and x-ray procedures.
Non-Sterile.
Single Patient Use.
Not made with natural rubber latex.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
CAUTION: See Warnings and Precautions. Consult Instructions for Use.

www.medline.com Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA.
Made in Taiwan/Fabriqué à Taïwan. 1-800-MEDLINE V3 RC23BTQ

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