CooperSurgical Milex MXWSFS Instrucciones De Uso

Vaginal Arcing and Omniflex Diaphragm Fitting Kit
Instructions 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.
DEVICE 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.
Arcing and Omniflex 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.
A properly fit Arcing and Omniflex Diaphragms 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 Arcing and Omniflex Diaphragms 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 Arcing and Omniflex 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.
INDICATIONS FOR USE
The Arcing and Omniflex 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.
WARNINGS
• 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. 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, the diaphragm should be removed and to contact their healthcare
professional immediately.
Diaphragm users should be instructed to consult their physician or other healthcare provider:
1. If they or their partner feel, or are made uncomfortable by the presence of the diaphragm.
2. 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.
3. If the diaphragm slips out of place when walking, coughing, sneezing or straining.
4. If the diaphragm no longer fits snugly above the pubic bone.
5. If at times other than menstruation there is blood on the diaphragm when it is removed.
6. If there are any holes, tears or other deterioration of the diaphragm.
7. If unable to remove the diaphragm.
8. 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.
9. 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.
10. Persons sensitive to silicone or spermicides used with the diaphragm should discontinue
use of the spermicide/diaphragm method of contraception.
CONTRAINDICATIONS
• A known hypersensitivity to silicone
• A history of toxic shock syndrome (TSS)
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 FITTING KIT
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 KIT INSTRUCTIONS FOR USE
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.
WARNINGS AND PRECAUTIONS
The fitting Diaphragms are not intended for contraception.
CLEANING/DISINFECTION INSTRUCTIONS
After each patient use, follow the combined cleaning/disinfection instructions below for the
diaphragm fitting kit.
1. CLEANING
Prepare a cleaning solution by mixing a mild soap (such as Dawn
using the soap manufacturer's recommended concentration. Prepare this solution in a container
large enough to fully submerge the device.
2. SOAK AND SCRUB
a. Soak the device in the container of prepared soap solution for a minimum of 5 minutes.
b. Following the 5-minute soak period, scrub the device for a minimum of 15 seconds with
a soft-bristled brush, such as a tooth brush and/or pipe brush. Scrub device below water
line to prevent aerosolization of contaminants.
c. Following scrub, inspect device for visible soil residue.
3. RINSE
a. Remove the device from the soap solution and thoroughly rinse under flowing tap water
for a minimum of 30 seconds.
b. Allow the device to dry.
HIGH LEVEL DISINFECTION
1. Prepare a container of Revital-Ox™ RESERT ® STERIS, Cidex ® OPA or equivalent
disinfectant in
a container large enough to fully submerge the device.
2. Transfer the device to the container to soak. Ensure that the device is completely immersed
in the disinfecting solution. Soak the device for at least 9 minutes in RESERT or 12 minutes
in Cidex OPA.
3. Rinse the device throughly in sterile water.
4. Place the clean ed/disinfected device in an appropriate dry storage area.
STERILIZATION
STERILIZATION EXPOSURE
PROCESS TEMPERATURE
Pre-Vacuum 273° F/134° C
Pre-Vacuum 270° F/132° C
Gravity 250° F/121° C
Pregnancy Probability
6-month Pregnancy
Contraception Method
Surgical Sterilization
Injectable Hormones Less than 1%
IUDs
Hormone Pills Vaginal
Ring
Male Condom
Contraceptive Diaphragm
Cervical Cap
Female Condom
These 1-year probabilities are projected since most barrier studies today are conducted as
1
6-month studies.
EXPLANATION OF SYMBOLS
REF
Reorder Number
Batch Code
Consult instructions for use
!
Caution
R Only
U.S. Federal law restricts this device to sale by or
x
on the order of a physician.
Manufacturer
Authorized Representative in the European
EC REP
Community.
LATEX
Not made with natural rubber latex.
Do not use if package is damaged
Dawn is a registered trademark of Proctor and Gamble Company.
®
Cidex is a registered trademark of Johnson & Johnson
®
CooperSurgical is a registered trademark of CooperSurgical, Inc.
®
or equivalent) with tap water
®
EXPOSURE
DRY TIME
TIME
3 minutes 30 minutes
4 minutes 30 minutes
30 minutes 30 minutes
12-month Pregnancy
Probability Probability
Less than 1%
1-2% 1-2%
7% 11%
1
8% 17%
11% 17%
13% 21%
1