CooperSurgical MXWSFS Instrucciones De Uso

Vaginal Wide-Seal Diaphragm Fitting Kit
Directions for Use (English)
Product No: MXWSFS Arcing Diaphragms
MXWFFS Omniflex Diaphragms
Sizes: 65 mm thru 85 mm
The diaphragms are made of Medical Grade silicone, are latex free, and are
autoclavable. Thoroughly rinse food grade powder off fitting diaphragm before
initial use. Cleanse the diaphragm before initial use by washing it with a mild,
non-perfumed detergent and warm water, rinsing and drying it carefully.
FITTING INSTRUCTIONS
To measure a patient for a diaphragm it is necessary to measure the distance from the
inside of the pubic symphysis to the posterior fornix.
To do this:
1. Bring your index finger and middle finger together and insert into vagina until you reach
the posterior fornix. Now lift your hand so that your index finger makes contact with the
pubic arch. Mark the point directly below the inferior margin of the pubic bone with the
tip of your thumb. Withdraw your fingers in this position.
2. Place one end of the fitting diaphragm on the tip of your middle finger. The opposite end
should lie in front of the thumb tip. This gives you the approximate diameter for the
diaphragm needed.
3. Select a fitting diaphragm closest to this diameter and insert into vagina. The proper size
will fit snugly in the posterior fornix and the anterior rim snugly under the pubic arch. Feel
the cervix to make sure it is completely covered by the dome of the diaphragm.
Suggestion: Try fitting the patient with one size smaller and one size larger diaphragm before
your final decision as to the correct size.
Remember: The vagina lengthens and widens during arousal so it is important the
diaphragm fits snugly allowing just enough room for finger to pass easily between the
diaphragm and the vaginal wall.
4. Ask the patient if she can feel the diaphragm; it should not be felt once in position.
5. Ask patient to do a Valsalva maneuver, cough or move about to check for comfort and to
be sure diaphragm is not displaced during normal activities.
6. If there is undue pressure or patient can feel the diaphragm, a smaller size should
be tried. If the diaphragm has been displaced a larger size or a diaphragm with a
different type spring should be tested.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
This device is not intended for contraception.
Duration of Use:
This device is intended for the sole purpose of properly fitting a diaphragm. It is
intended to be inserted only for the time necessary only for the diaphragm to be sized.
Diaphragm Fitting:
The size and shape of the vagina change and this may require a new size diaphragm.
As a matter of routine, each time a pelvic examination is performed, refitting should be
done.
STERILIZATION OF FITTING DIAPHRAGMS
1. Prior to autoclaving, clean fitting diaphragm by scrubbing AFTER EACH USE with mild
soap, including area under lip of the wideseal and rinsing thoroughly under
running water. This should help remove all the bioburden deposited on the fitting
diaphragm.
2. Gravity Autoclave 250 °F (121 °C) + 3 degrees for 20 to 30 minutes. The difference in
time is dependent upon whether the diaphragm is wrapped or unwrapped during
autoclaving.
3. Allow to air dry then return to fitting container.
A fitting diaphragm must be sterilized following each patient fitting.
ACTIONS
A diaphragm, when properly fitted, serves two purposes: to stop sperm from entering
the cervical canal and to hold spermicide.
INDICATIONS
Wide-Seal Silicone Diaphragms, in conjunction with an approved spermicidal gel or cream
are indicated for the prevention of pregnancy in women who elect to use diaphragms as a
method of contraception.
CONTRAINDICATIONS
• A known hypersensitivity to silicone
• A history of toxic shock syndrome (TSS)
WARNINGS
• The diaphragm should remain in place for at least six hours after intercourse. It should be
removed as soon after this as possible.
A diaphragm should not be worn continuously for more than 24 consecutive hours. Continuous
prolonged wearing of the diaphragm may encourage the growth of certain bacteria in the vagina.
These bacteria can lead to symptoms 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.
SYMPTOMS OF TOXIC SHOCK SYNDROME (TSS)
1. Sudden high fever (102 °F/39 °C or over).
2. Nausea, vomiting and/or diarrhea.
3. Fainting, feeling faint or dizziness when standing up.
4. Rash over much of body (may resemble sunburn).
5. Weakness, tenderness and/or aching or pain of muscles and/or joints.
6. Sore throat, red eyes, and general feeling of weakness.
Instruct your patients that if they experience a sudden high fever and one or more of the
above symptoms, they should remove the diaphragm and contact their healthcare
professional immediately.
WARNING
Diaphragm users should be instructed to consult their physician or other healthcare
provider:
1. If they are not sure about the insertion and placement of the diaphragm.
2. If they or their partner feel, or are made uncomfortable by the presence of the
diaphragm.
3. If they 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.
4. If the diaphragm slips out of place when walking, coughing, sneezing or straining.
95 Corporate Drive • Trumbull, CT 06611 USA
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www.coopersurgical.com
MIL0620-DFU • Rev. A • 4/14
5. If the diaphragm no longer fits snugly above the pubic bone.
6. If at times other than menstruation there is blood on the diaphragm when it is removed.
7. If there are any holes, tears or other deterioration of the diaphragm.
8. If unable to remove the diaphragm.
9. IMPORTANT - For contraceptive effectiveness, the diaphragm should remain in place
for six to eight hours (depending on the spermicide that is used) after intercourse and it
should be removed thereafter. Continuous wearing of a contraceptive diaphragm for
more than twenty-four hours is not recommended. Removal of the diaphragm before six
to eight hours may increase risk of becoming pregnant.
Wearing 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 (TSS). Primary symptoms of TSS are sudden high fever (102 °F/39 °C
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.
10. The size and shape of the vagina change and this may require a new size diaphragm.
As a matter of routine, each time a pelvic examination is performed, refitting should be
done. Even if the diaphragm size does not change, it is advisable to replace the
diaphragm every two years or sooner.
11. 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.
12. Persons sensitive to silicone or spermicides used with the diaphragm should discontinue
use of the spermicide/diaphragm method of contraception.
INSTRUCT PATIENTS
1. Not to douche or remove diaphragm for at least six hours after coitus. Diaphragm should be
removed as soon after this as possible. Removal of diaphragm before six hours may
increase the risk of pregnancy.
2. Not to wear diaphragm for more than 24 consecutive hours. Continuous
prolonged wearing of the diaphragm may encourage the growth of certain bacteria in the
vagina. It has been suggested that under certain conditions, this over growth of bacteria
can lead to Toxic Shock Syndrome (TSS). Primary symptoms of TSS are
sudden high fever (102 °F/39 °C or higher), nausea, vomiting, fainting or feeling faint,
weakness, muscle or joint pain, sore throat and red eyes.
3. To be resized for a diaphragm if there is a gain or loss of ten or more pounds, if the patient
has had a baby, an abortion or any kind of pelvic/vaginal surgery. It is also
advisable to have a refitting each time patient has a routine physical examination.
DIAPHRAGM DESCRIPTION
• The Silicone Arcing Diaphragm is a molded, flesh-colored, latex-free, silicone
diaphragm which is compressible on one plane only. It is folded for insertion by
bringing the two notched sites on the inner lip together.
• The Silicone Omniflex Diaphragm is a molded, flesh-colored, latex free,
silicone non-arcing diaphragm which can be bent for insertion, at any point.
Purpose of the wide-seal lip
1. To help prevent sperm from entering the cervical canal.
2. To better retain the spermicidal gel when inserting the diaphragm.
3. To increase the barrier protection.
Advantage of Wide-Seal Diaphragm
A properly fit Wide-Seal Silicone Diaphragm remains in place not only by virtue of tension
between the spring and vaginal wall, but also because of suction created by the close contact
of the lip of the Wide-Seal Diaphragm with the vaginal mucosa. Because this
double action helps assure the diaphragm will remain in place, it may be possible to fit the
patient with a smaller size should she fall between two sizes. This helps avoid the
discomfort which occurs because of too much pressure on the urethra and bladder neck,
when fitted with too large a size.
How Supplied
The Wide-Seal Silicone Diaphragms are available in sizes 60 mm thru 95 mm, in
5 mm increments.
The Fitting Kits include a set of diaphragms from 65 mm to 85 mm, in 5 mm increments.
Pregnancy Probability
Contraception Method
Surgical Sterilization
Injectable Hormones
IUDs
Hormone Pills
Vaginal Ring
Male Condom
Contraceptive Diaphragm
Cervical Cap
Female Condom
1 These 1-year probabilities are projected since most barrier studies today
are conducted as 6-month studies.
EXPLANATION OF SYMBOLS
Reorder Number
REF
LOT
Batch Code
Consult instructions for use
!
Caution
U.S. Federal law restricts this device to
R Only
x
sale by or on the order of a physician.
Manufacturer
© 2014 CooperSurgical, Inc.
International
Phone: (203) 601-9818
Fax: (203) 601-4747
6-month Pregnancy 12-month Pregnancy
Probability Probability
Less than 1% Less than 1%
1-2% 1-2%
7% 11% 1
8% 17%
11% 17%
13% 21% 1
Product conforms to the
Medical Device
Directive 93/42/EEC
Authorized Representative
EC REP
in the European
Community.
Not made with natural
rubber latex.
EC REP
CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Made in the USA