General Information - CooperSurgical Milex Instrucciones

EN
Fitting Instructions for the Healthcare Professional

GENERAL INFORMATION

PURPOSE
The Milex Pessary Fitting Kit was developed to help you as a
®
healthcare professional determine accurate pessary type and size
prior to prescribing a pessary for your patient.
INDICATIONS FOR USE
See individual Pessary sections in this document for indications.
CONTENTS
The pessaries included in this kit are: INCONTINENCE DISH with
Support, RING with Support, DONUT, GELLHORN and CUBE.
Also included in this kit are a foam model, carrying case and
pessary size chart.
TRIMO-SAN™* and a Jel-Jector Applicator with instructions are
only included in kits sold in the U.S.
WARNING: Fitting pessaries are not to be worn more
than 15 minutes.
FITTING INSTRUCTIONS
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.
• 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
within 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.
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.
RECOMMENDED CLEANING, HIGH LEVEL DISINFECTION
AND STERILIZATION INSTRUCTIONS**
CLEANING
1. Prepare a cleaning solution by mixing a mild soap (such
as Dawn or equivalent) with tap water using the soap
®
manufacturer's recommended concentration. Prepare this
solution in a container large enough to fully submerge the
device.
* TRIMO-SAN is not sold outside the USA.
**New pessaries are powdered with food-grade powder.
Milex Pessary Fitting Kit
®
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
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 cleaned/disinfected device in an appropriate dry
storage area.
STERILIZATION
Sterilization Exposure
Process Temperatuare
Pre-Vacuum 273 °F / 134 °C
Pre-Vacuum 270 °F / 132 °C
Gravity 250 °F / 121 °C
INCONTINENCE DISH with Support
Fitting Pessary
For stress urinary incontinence with mild prolapse
Fitting pessary sizes available in kit and corresponding pessary sizes
INCONTINENCE DISH with Support
Fitting Kit
Replacement
Pessary Part No. Size
MXFIT0801 2
MXFIT0802 3
MXFIT0803 4
MXFIT0804 5
3
STERIS,
®
Exposure
Time
3 minutes
4 minutes
30 minutes
Product Part
No. inches
MXPCONDS02 2-1/2"
MXPCONDS03 2-3/4"
MXPCONDS04 3"
MXPCONDS05 3-1/8"
Dry Time
30 minutes
30 minutes
30 minutes
mm
65 mm
70 mm
75 mm
80 mm