Cooper Surgical Milex Guia De Inicio Rapido

CAUTION: U.S. Federal law restricts this device
to sale by or on the order of a physician.
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (800) 243-2974
Fax: (800) 262-0105
EC REP
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
MXFITDON-DFU • Rev. A • 6/13
GENERAL INFORMATION
PURPOSE
®
The Milex Pessary Fitting Kit was developed to help you as a
health care professional determine accurate pessary type and size
prior to prescribing a pessary for your patient.
CONTENTS
The pessaries included in this kit are: Incontinence Dish with
Support, Ring with Support, Donut, Gellhorn and Cube. The shaded
area indicates sizes recommended for pessary inventory, as they are
the most common sizes. With these sizes you will be able to fit
approximately 85% of patients. Also included in this kit are a foam
model and carrying case.
Warning: Fitting pessaries are not to be worn more than
15 minutes!
LATEX-FREE CURRENT SILICONE INFORMATION:
CooperSurgical has had nontoxic silicone gynecologic devices
available for hyper-allergic patients for more than 10 years.
ADVANTAGES OF SILICONE:
1. Longer shelf life and use life
2. Can be autoclaved
PESSARY CARE:
Pessaries are powdered with food-grade powder. The powder must
be washed off with a mild soap and the pessary thor ough ly rinsed with
water and dried prior to initial use.
Prior to insertion of any pessary, it is important to thoroughly clean and
remove any matter that may be on the outer surface. CooperSurgical
recommends washing with mild soap and thoroughly rinsing with water
prior to initial use.
®
Milex Donut Fitting Kit
Replacement Pessary
Fitting Instructions for the
Health Care Professional
FITTING
PESSARIES
ARE NOT
TO BE
WORN MORE
THAN
15 MINUTES!
0086
Made in the USA
International
Phone: (203) 601-9818
Fax: (203) 601-4747
CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611 USA
The yellow Milex fitting pessaries are designed to be used in the
physician's office for selecting and fitting the correct pessary for
individual patient use and should only be worn in 15-minute
increments, as many of the fitting pessaries do not have nylon pegs
for support. The yellow fitting pessaries should be cleaned and
sterilized prior to fitting each patient but do not need to be stored in
a sterile environment.
With the realization that many different techniques are practiced in
the health care community, we attempted to optimize methods to
afford the best coverage for our customers. Every facility should
validate its own equipment and parameters before processing any
medical device.
RECOMMENDED CLEANING BEFORE INSERTION
• Decontamination/Disinfection: CIDEX
• The agent must be thoroughly rinsed off with water.
RECOMMENDED STERILIZATION BEFORE INSERTION
Pre-vacuum: 270 °F - 275 °F (132 °C - 135 °C) for 4 minutes
Gravity displacement: 250 °F - 255 °F (121 °C - 124 °C) for
40 minutes
FITTING IN STRUC TIONS FOR THE HEALTH CARE PROFESSIONAL
IMPORTANT
• Pessaries are fitted by trial and error. There are no mechanical
devices available that can accurately determine the size or type
of pessary your patient requires to obtain the desired results.
• Fitting diaphragms should not be used to measure the size
pessary a patient will need. Diaphragms fit differently from
pessaries.
• Even before fitting a pessary, the patient should be informed that
it is not uncommon to have to change the size or type of pessary
more than once after being originally fitted. This is why it is so
important that your patient be instructed to return with in
24 hours of the initial fitting and again in 72 hours. Thereafter,
re-examination every few months is recommended to ensure that
a proper fit is maintained as long as the patient is wearing the
pessary.
• At each visit the pessary should be removed and the vaginal vault
inspected for signs of allergic reaction or undue pressure.
• 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 the patient
under ideal circumstances.
• The INFLATOBALL™, CUBE and TANDEM-CUBE pessaries are
the three exceptions to the above. Patients must be instructed to
insert, remove and clean these pessaries daily.
• The CUBE and TANDEM-CUBE pessaries fill the entire vaginal
vault and have no area for drainage. The INFLATOBALL pessary
should not be left in place more than 24 consecutive hours.
• A noncompliant patient should not be fitted with any 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: Each type of pessary is available in a wide range of sizes –
most pessaries are made in 7 to 14 different sizes.
Experience has shown that in order to properly fit a pessary, you
should have at least one of the most commonly used sizes of the
pessary (see the size charts).
Note: When you purchase the pessaries for your patients, detailed
fitting instructions are included in the box for your use along with
pessary instructions for the patients.
® OPA for 12 minutes
MXFITDON-DFU • Rev. A • 6/13