ORTHO Diaphragm Kits include two different types in a variety of sizes.

The ALL-FLEX® Arcing Spring Diaphragm is a molded, buff-colored, dry natural rubber vaginal diaphragm containing a distortion-free, dual spring-within-a-spring which provides unique arcing action no matter where the rim is compressed. It is appropriate not only where ordinary diaphragms are indicated, but also in patients with mild cystocele, rectocele or retroversion.
The ORTHO® Coil Spring Diaphragm is a molded dry natural rubber vaginal diaphragm. The rim encases a tension-adjusted spring which allows for compressibility in one plane only, thus allowing insertion with the ORTHO UNIVERSAL INTRODUCER.

ACTION

These Diaphragms when properly fitted serve two purposes:

To stop the sperm from entering the cervical canal;
To hold the spermicide.

INDICATIONS

ORTHO Diaphragms, in conjunction with an appropriate spermicide, are indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.

The diaphragm should always be used in combination with a spermicidal jelly (or cream) [e.g., ORTHO OPTIONS™ GYNOL II® Original Formula Contraceptive Jelly, ORTHO OPTIONS™ ORTHO-GYNOL Contraceptive Jelly.

CONTRAINDICATIONS

Known hypersensitivity to dry natural rubber and/or prior history of Toxic Shock Syndrome (TSS).

An association has been reported between diaphragm use and toxic shock syndrome (TSS), a serious condition which can be fatal.

For contraceptive effectiveness, the diaphragm should remain in place for six hours after intercourse and should be removed as soon as possible thereafter .

Continuous wearing of a contraceptive diaphragm for more than twenty-four hours is not recommended. Removal of the diaphragm before six hours may increase the risk of becoming pregnant. Retention of the diaphragm for any period of time may encourage the growth of certain bacteria in the vaginal tract. It has been suggested that under certain as yet unestablished conditions, overgrowth of these bacteria may lead to symptoms of toxic shock syndrome.

Primary symptoms of TSS are sudden high fever (usually 102° or more), and vomiting, diarrhea, fainting or near fainting when standing up, dizziness or a rash that looks like sunburn. There may also be other signs of TSS such as aching of muscles and joints, redness of the eyes, sore throat and weakness. Patients should be instructed that if they experience sudden high fever and one or more of the other symptoms, they should remove the diaphragm and consult their physician or health care provider immediately.

Latex or Natural Rubber Sensitivity

The ORTHO Diaphragm contains dry natural rubber proteins. Persons sensitive to latex or natural rubber may have an allergic reaction to the diaphragm. If this occurs, discontinue use and consult your doctor or health care provider.

PRECAUTIONS

Diaphragm users should be instructed to consult their physician or health care provider:

If they are not sure about the insertion and placement of the diaphragm.
If they or their partner feel or are made uncomfortable by the presence of the diaphragm.
If you experience any discomfort or pain while the diaphragm is in place. This may be due to incorrect diaphragm insertion, an abnormal pelvic condition, constipation or incorrect diaphragm size.
If the diaphragm slips out of place when walking, coughing, or straining.
If the diaphragm no longer fits snugly above the pubic bone.
If at times other than menstruation there is blood on the diaphragm when it is removed.
If there are any holes, tears or other deterioration of the diaphragm.
If unable to remove the diaphragm.
IMPORTANT --For contraceptive effectiveness, the diaphragm should remain in place for six hours after intercourse and should be removed as soon as possible thereafter . Continuous wearing of a contraceptive diaphragm for more than twenty-four hours is not recommended. Removal of the diaphragm before six hours may increase the risk of becoming pregnant. Retention of the diaphragm for any period of time may encourage the growth of certain bacteria in the vaginal tract. It has been suggested that under certain as yet unestablished conditions, overgrowth of these bacteria may lead to symptoms of toxic shock syndrome. Primary symptoms of TSS are sudden high fever (usually 102° or more), and vomiting, diarrhea, fainting or near fainting when standing up, dizziness or a rash that looks like a sunburn. There may also be other signs of TSS such as aching of muscles and joints, redness of the eyes, sore throat and weakness. If the patient has a sudden high fever and one or more of the other symptoms, the diaphragm should be removed immediately and TSS should be considered.
Diaphragm users should have another diaphragm fitting if they have lost or gained more than ten pounds, have had the diaphragm for more than a year, or have had a baby or an abortion. As a matter of routine, each time a pelvic examination is performed, refitting should be done. The size and shape of the vagina changes and this may require a new size diaphragm. Even if the diaphragm size does not change, it is advisable to replace the diaphragm every two years or sooner.
Diaphragms may increase the risk of urinary tract infections especially if not properly fitted. Patients should be instructed to consult their physician if they experience any of the signs or symptoms of this type of infection which include pain on urination, blood in the urine, elevated temperature, frequent urination, or a sensation of obstruction while urinating.
Persons sensitive to dry natural rubber may have an allergic reaction to diaphragm use.
Persons sensitive to spermicides used with the diaphragm should discontinue use.
Petroleum jelly, mineral oil, vegetable oil and cold cream lubricants should NOT be used concurrently with the diaphragm.

INSTRUCTIONS

Proper placement of the diaphragm is vital for effectiveness.
To be fully effective the diaphragm should never be used without contraceptive cream or jelly. The contraceptive cream or jelly must be spread around the inner surface of the diaphragm as well as around the rim.
To avoid pregnancy the diaphragm must be used every time there is intercourse.
The diaphragm may be inserted up to six hours before intercourse. If more than six hours has elapsed between insertion of the diaphragm and intercourse, additional contraceptive jelly or cream must be inserted. The diaphragm should not be removed to insert this additional cream or jelly.

The following Patient Instructions for insertion and removal are contained in the leaflet "After your doctor or health care provider Prescribes your Ortho Diaphragm" which is included in each Ortho Diaphragm Kit.

Preparing for insertion

Cleanse the diaphragm before initial use by washing it with mild, non-perfumed soap and warm water, rinsing and dry it carefully.

Empty your bladder (urinate) and wash your hands thoroughly before insertion.

Examine the diaphragm carefully before use by holding it in front of a light to make sure it has no cracks or tiny holes. Take care not to stretch or puncture the diaphragm with sharp fingernails. Do not use if you observe any visible cracks or holes.

The diaphragm should always be inserted before intercourse. To prepare your diaphragm for insertion, you should put the spermicide into the cup of the diaphragm. This ensures that the spermicide is placed between the cervix and the diaphragm. Use the amount of spermicide recommended by the manufacturer of the spermicide you use.

Using your finger tip, spread some of the spermicidal jelly (or cream) around the rim of the diaphragm that will be in contact with the cervix (entrance to the womb). If the amount applied to the rim is excessive, it will be difficult to control the diaphragm during insertion.

You can insert the diaphragm while you are standing with one leg up, squatting, or lying down. The position of the cervix and the walls of the vagina will be different depending on your position. If you are used to one position and then change to another, take extra care in positioning the diaphragm to be sure the cervix is covered.

Inserting the diaphragm

Hold the diaphragm with the dome down (spermicide up) and press the opposite sides of the rim together between your thumb and third finger. The diaphragm can be held from above or below.

Separate the lips of your vagina with your free hand. Hold the compressed diaphragm with the dome down (spermicide up) and push it gently inward, along the rear wall of the vaginal canal, directing it backwards as far as it can go. Your index finger, kept on the outer rim of the diaphragm, helps to guide the diaphragm into place.

Always insert the diaphragm as far back as it will go behind the mouth of the cervix. Then push the front rim of the diaphragm up until it is locked in place just behind the pubic bone.

It is important that the cervix be covered by the spermicide and the diaphragm and that the diaphragm be locked in place between the upper edge of the pubic bone and the rear wall of the vagina. Test for correct position by running the index or middle finger over the diaphragm' dome to be sure it covers the cervix.

The cervix will feel like the end of your nose. It is normal to feel folds in the diaphragm when it is in place.

Bodily movements or changes in position should not dislodge a correctly-inserted diaphragm. A properly-fitted diaphragm should stay in place during urination or bowel movement.

Preparing the diaphragm when using an introducer

The introducer has been designed to insert diaphragms from size 60mm through 90mm. The introducer is slightly indented and used to hold one side of the diaphragm rim for insertion. The ORTHO Diaphragm has the size molded into the side of the rubber dome so that it is easy to read throughout the life of the diaphragm.

Hold the introducer in either hand with the notched-side down. Hold the diaphragm in your other hand with the dome up. Squeeze the opposite sides of the diaphragm together and place one end of the diaphragm' rim into the notched end of the introducer, then fit the other end of the diaphragm over the notch corresponding to your diaphragm size (sizes are shown next to each notch on the introducer.)

Turn the introducer over and insert the amount of spermicidal jelly (or cream) recommended by the manufacturer of the spermicide you use into the folds formed on the top of the diaphragm (the cup side.) This ensures that the spermicide is placed between the cervix and the diaphragm. Using your fingertip, spread some of the spermicidal jelly (or cream) around the rim of the diaphragm to make insertion easier and to help seal the diaphragm in place.

Inserting the diaphragm when using an introducer

With the spermicide up, insert the introducer into the vagina. Press gently inward along the rear wall of the vagina until the diaphragm has been inserted as far as possible.

Once the diaphragm is in place, twist the introducer slightly to the left or right to release the diaphragm. Then, gently withdraw the introducer. Using your index finger, check to ensure the near rim of the diaphragm is pushed up behind the pubic bone.

Test for correct position by running the index or middle finger over the diaphragm' dome to be sure it covers the cervix. The cervix will feel like the end of your nose. It is normal to feel folds in the diaphragm when it is in place.

To cleanse the introducer, wash with soap and warm water, rinse and dry.

Removing the Diaphragm

To reduce the risk of TSS the diaphragm should be removed six (to eight) hours after intercourse (depending upon which brand of spermicide you use.) Continuous wearing of a diaphragm for more than 24 hours is not recommended. (See AND PRECAUTIONS FOR USE.)

Removal of the diaphragm before six (to eight) hours after intercourse (depending on which brand of spermicide you use), may increase your risk of becoming pregnant.

Do not douche until the diaphragm is removed. To remove the diaphragm, put your index finger behind the from rim and pull the diaphragm down and out. Avoid puncturing the diaphragm with your fingernails.

To facilitate removal, straining down as with a bowel movement may help to push the rim down so that the index finger can reach the rim more easily. If suction is holding the diaphragm, the suction may be broken by placing a finger between the vaginal wall and the rim.

If your menstrual period begins while the diaphragm is in place and blood is found in the cup of the diaphragm when it is removed, do not be concerned as this is not harmful.

CARE OF THE DIAPHRAGM

After removal of the diaphragm, it should be cleansed thoroughly with mild, non-perfumed soap and water, rinsed and dried carefully. Powders should not be used with the diaphragm. Never boil the diaphragm or use antiseptic solutions in cleaning it.

Store the diaphragm, unrolled, in its original container. Do not allow the diaphragm to dry in the open. Prolonged exposure to light or heat will deteriorate the rubber.

Never stretch or puncture the diaphragm with sharp fingernails. With regular use, and in the absence of evident deterioration, the diaphragm should be replaced every 1-2 years.

Some vaginal medications and lubricating agents may contain ingredients that can damage a contraceptive diaphragm. You should discuss the use of any such vaginal preparation with your doctor, health care provider, pharmacist or the manufacturer or distributor. Petroleum jelly, mineral oil, vegetable oil and cold cream lubricants should NOT be used concurrently with the diaphragm.

Where to purchase Ortho Contraceptive Products

The ORTHO® Universal Introducer is available by prescription through pharmacies.

These Ortho contraceptive jelly brands for use with diaphragms are available without a prescription at most pharmacies and some grocery stores.

ORTHO OPTIONS™ GYNOL II® Original Formula large tube only--3.8 oz.

ORTHO OPTIONS™ GYNOL II® Extra Strength includes applicator w/small tube

ORTHO OPTIONS™ ORTHO-GYNOL® large tube only--3.8 oz.

If added vaginal lubrication is necessary, you may want to consider K-Y® BRAND Jelly Personal Lubricant which is available without a prescription in a .4 oz., 2 oz. and a 4 oz. tube. K-Y® Liquid and K-Y® Long Lasting™ vaginal moisturizer. K-Y® BRAND Jelly Personal Lubricant is not a contraceptive.

HOW SUPPLIED

All ORTHO Diaphragm Kits are available individually and contain a tube of ORTHO OPTIONS™ GYNOL II Original Formula Contraceptive Jelly.

The ALL-FLEX Arcing Spring Diaphragm is available in sizes 55mm through 95mm in 5mm increments.
The ORTHO Coil Spring Diaphragm is available in sizes 55mm through 95mm in 5mm increments.

HOW TO FIT ORTHO DIAPHRAGMS

To measure for diaphragm size:
Hold index and middle fingers together and insert into vagina up to the posterior fornix. Raise hand to bring surface of index finger to contact with pubic arch.
Use tip of thumb to mark the point directly beneath the inferior margin of the pubic bone and withdraw finger in this position.
To determine diaphragm size:
Place one end of rim of fitting diaphragm or ring on tip of middle finger. The opposite end should lie just in front of the thumb tip. This is the approximate diameter of the diaphragm needed.
Insert a fitting diaphragm or ring of the appropriate size into the vagina.
Try both a larger and a smaller size before making a decision.
The proper size will fit snugly in the posterior fornix and behind the pubic arch without undue pressure.

Revised May 2000